- Email: [email protected]
A tracheostomy obturator for a patient with hereditary angioneurotic edema
A tracheostomy obturator for a patient with hereditary angioneurotic edema Marty G. Moon, DDS,a Robert Taft, DDS,b Robert Robinson,c and Roy Marrerod Walter Reed Army Medical Center, Washington, DC; National Navy Dental Center, Bethesda, Md This article describes a technique for fabrication of a custom tracheostomy obturator for a patient with hereditary angioneurotic edema and a permanent tracheostoma. The impression technique and fabrication of a custom tracheostoma valve retainer for a laryngectomy patient closely mirrors the technique used for fabricating a tracheostomy obturator. (J Prosthet Dent 2004;91:494-8.)
H
ereditary angioneurotic edema (HAE), also known as congenital C1-inhibitor deficiency, is a rare autosomal dominant complement–mediated disease.1,2 Activation of the complement system increases vascular permeability.3 C1-esterase inhibitor (C1-INH) suppresses activation of the complement system and decreases vascular permeability.3 In HAE, the activation of the complement system cannot be inhibited due to the deficiency or alteration of the antigenic and/or functional C1-INH. The resulting increase in vascular permeability causes angioedema.3 Accumulation of bradykinin, not histamine, seems to be responsible for the activation of the complement system.4,5 Clinically, HAE is characterized by recurrent circumscribed, nonpitting, and nonpruritic subepithelial swellings of sudden onset, which can be fully manifested within a few hours.6,7 Its presentation has been observed to diminish during the course of 48 to 72 hours, but it can persist up to 1 week.6,7 Lesions can be solitary or multiple and primarily involve the extremities, larynx, face, and bowel wall. The bronchial trees are never involved in attacks of HAE.2 The frequency and severity of attacks varies considerably and may fluctuate over time. Well-known precipitating events are mental and physical stress, minor trauma, insect stings, food, alcohol, dental or surgical procedures, infections, and trivial activities such as typing, prolonged writing, pushing a lawn mower, hammering or standing in place for a few hours.3,6-10 In about half of reported instances, a precipitating event cannot be identified.6,10 Many The opinions or assertions herein are the private view of the authors and are not to be construed as official or reflecting the views of the Department of Defense. Identification of commercial materials and equipment in this report does not imply official recommendation or endorsement or that the materials and equipment are necessarily the best available for the purpose. a Colonel, US Army Dental Corps; Chief, Department of Maxillofacial Prosthetics, Walter Reed Army Medical Center. b Captain, US Navy; Chairperson, Department of Maxillofacial Prosthetics, National Naval Dental Center. c Dental Technician 2nd Class, US Navy; Section Leader, Department of Maxillofacial Prosthetics, National Naval Dental Center. d Dental Technician 2nd Class, US Navy; Department of Maxillofacial Prosthetics, National Naval Medical Center.
494 THE JOURNAL OF PROSTHETIC DENTISTRY
times HAE resolves without harm; however, laryngeal or tracheal angioedema may result in asphyxiation, which remains the major cause of death.3,6-13 Before the advent of therapy, mortality resulting from asphyxiation was as high as 30%.6,8,9,13 Three distinct phases in the management of HAE are recognized: (1) treatment of exacerbation, (2) shortterm prophylaxis, and (3) maintenance therapy.10,12 Exacerbation is managed by supportive therapy with particular attention to maintaining an airway. Severe oropharyngeal angioedema may necessitate emergency intubation and/or tracheostomy, and such patients are monitored closely in a hospital setting until the attack resolves.12 Prophylactic administration of either attenuated androgens or protease inhibitors has proven useful in reducing frequency or severity of attacks.6,7,12 The current treatment of choice for acute attacks of HAE is replacement therapy with purified vapor-heated C1INH, as it is safe and effective for both preventing and treating attacks.6,14-18 Rarely, due to a high frequency of HAE attacks, severe laryngeal angioedema, significant adverse effects from antifibrinolytic drugs, and noncompliance with taking medications, patients may request a permanent tracheostoma (Fig. 1).8 For these patients, the tracheostoma provides a patent airway for breathing when they experience a severe oropharyngeal angioedema episode. HAE patients with a tracheostoma can benefit from the fabrication of a tracheostomy obturator. There are several benefits of the tracheostomy obturator. It functions to prevent healing by primary intention, prevent stenosis of the tracheostoma, improve cosmetics, restore speech function, restore the airway particle filtration system, increase airway resistance for adequate exchange of gases in the lungs, increase heating and humidification of the inhaled air, and improve patient’s psyche for coping with the disease, and it can be removed quickly to obtain a patent airway when the patient experiences a severe oropharyngeal angioedema episode. Techniques for the fabrication of the tracheostomy obturator have been described in the literature.19-21 Rudd et al20 used alginate impression material to obtain VOLUME 91 NUMBER 5
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2.
3.
Fig. 1. Anterior view of tracheostoma.
an impression of the defect and employed safeguards in case of accidental aspiration of the impression material. The obturator was fabricated out of a flexible resin and was used for approximately 2 months. At the end of the 2-month period, the patient’s condition had improved, and surgical closure was complete. Harley and Rothwell21 fabricated molds from stainless steel tracheotomy tubes of various diameters in reversible hydrocolloid and poured autopolymerizing acrylic resin in the molds. The obturators were employed in situations where the original tracheotomy tube was removed but where it was not totally certain that the patient would continue to breathe independently of the tracheal opening. Once the obturator was no longer required, different obturators of decreasing diameter were employed to accommodate for normal healing and closure. Impression technique and fabrication of a custom tracheostoma valve retainer for a laryngectomy patient closely mirrors the technique used for fabricating a tracheostomy obturator.22-29 However, a patient breathes primarily through the custom tracheostoma valve retainer, and the tracheostomy obturator provides an emergency airway if the primary airway is constricted or blocked by severe laryngeal angioedema. The goal in fabricating a tracheostomy obturator is to provide retention of the prosthesis through muscle contraction and an intimate fit with the internal surface of the trachea, thereby limiting it from becoming dislodged by any excessive patient body movements. This article describes a technique for fabrication of a custom tracheostomy obturator for an HAE patient with a permanent tracheostoma.
4.
5.
TECHNIQUE 1. Perform the moulage-making procedures in a hospital clinical setting with a head and neck surgeon available to manage a possible airway emergency. Ensure the presence of the dental high-speed MAY 2004
6.
evacuation system and a tracheostomy tube in the event of accidental aspiration of impression material. Seat the patient in an upright position. Make the preliminary moulage of the tracheostoma and surrounding tissue using vinyl polysiloxane (VPS) putty (Exaflex; GC America Inc, Alsip, Ill). Mold the putty gently around the surrounding soft tissues and slightly into the tracheostoma. Box and pour the preliminary moulage in Type V dental stone (Die-Keen Green; Heraeus Kulzer Inc, South Bend, Ind). Fabricate a custom acrylic resin tray (Fastray; Bosworth Co, Skokie, Ill) that extends 2 to 3 cm beyond the tracheostoma margins. Design the custom tray with a handle on the cameo surface and 4 tissue stops positioned quadrilaterally, 2 cm from the margins of the defect, on the intaglio surface. Use 24-gauge relief metal (Grobet USA, Carlstadt, NJ) and 2 layers of baseplate wax (Medium Soft Pink Wax No. 3; Hygenic Corp, Akron, Ohio) as a spacer. At chairside, practice placing the impression tray in the proper position as oriented from the moulage cast. Remove the relief metal and wax spacer. Place multiple perforations in the tray with a round bur (no. 6; Midwest Dental Products Corp, Des Plaines, Ill) to allow release of impression material hydrostatic pressure and adhesion. Paint VPS adhesive (Universal VPS Adhesive; GC America Inc) on the tray. Spread the approximate volume of impression material simulating the previously removed wax (spacer), and place impression material around the tray to contact the tracheostoma. Make the intermediate moulage with VPS light or medium body impression material (Examix, GC America Inc), ensuring the impression material flows away from the tracheostoma to prevent aspiration of material. Remove the VPS impression material from the part of the custom tray touching and extending into the tracheostoma. Add mouth-temperature wax (Adaptol; J.F. Jelenko, Armonk, NY) to the areas where the VPS was removed. Ask the patient to functionally mold the wax with head and shoulder movements, swallowing, and speech articulations. Perform this step in a hospital clinical setting with a head and neck surgeon available to manage a possible airway emergency. Add wax in small increments to prevent breakage and possible tracheal aspiration of wax. Evaluate wax impression for fit and seal before each wax addition. Stop making the wax impression of the tracheostoma when there is a continuous, uniformly smooth surface (Fig. 2). Chill the completed wax impression in ice water. Box the definitive functional moulage. Sharpen the ends of approximately 20, 4-inch–long, 495
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Fig. 2. Intaglio view of definitive moulage with wax impression.
Fig. 3. Occlusal view of perforated stone mold drag.
Fig. 4. Skin surface characteristics on wax surface.
Fig. 5. Occlusal view of stone mold cope.
.036-inch–diameter, standard round, stainless steel, orthodontic wires (3M Unitek, Monrovia, Calif). Lubricate the wires with a stone-separating medium or tin foil substitute. Perforate the impression with the wires. Align wire parallel to the height of the boxing wax (Dental Boxing Wax; Moyco Union Broach, York, Pa). Pour the final functional moulage in Type V dental stone. After the dental stone has set for 48 hours, place the attached moulage to the stone complex in a water bath. Heat the water bath to 498 to 538C (1208 to 1308F) to soften the wax. Separate moulage from the undercuts without compromising the integrity of the cast. Remove the wires from the perforated stone mold drag (Fig. 3). Eliminate the undercuts just inside the tracheostoma orifice with blockout wax (Bellewax; Belle De St. Claire, Chatsworth, Calif). Burnish 24-gauge relief metal (Grobet USA) over the blockout wax and mold. Prepare a baseplate wax pattern on the mold. Remove pattern from the mold without breaking. Place additional blockout 496
wax in undercuts if the pattern breaks upon removal, and readapt the pattern to mold. 7. Evaluate the wax pattern on the patient for adequate fit, seal, and retention. Evaluate the patient and the mold to determine if increased retention is needed. Increase retention for the wax pattern by lightly scraping the undercut areas in the stone mold and readapting the wax pattern. 8. Begin tinting and custom intrinsic staining of the prosthesis. Mix silicone (MDX 4-4210 Silicone; Dow Corning Corp Medical Products, Midland, Mich) with 10% kaolin by weight, without catalyst. Tint the MDX 4-4210 Silicone using the various colorants, flocking, and earth pigments to match the patient’s skin tone to establish the base shade for the prosthesis. 9. Index keyways with a laboratory carbide bur (Goldies Shape B ½; Dedeco Int Inc, Long Eddy, NY) in a dental lathe (Baldor Polishing Lathe; Baldor Electric Co, Ft Smith, Ariz) in the perforated stone mold drag, and seal the wax VOLUME 91 NUMBER 5
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Fig. 6. Properly trimmed tracheostomy obturator.
Fig. 8. Prosthesis (>1 year wear) post placement demonstrating color change and loss of marginal adaptation.
pattern. Develop skin surface characteristics on the wax surface (Fig. 4). Apply a tin foil substitute. Box and pour with Type V dental stone to form the cope portion of the stone mold (Fig. 5). Allow the stone to set for 48 hours, then separate, trim, and boil out wax residue. Clean the mold surfaces using a stiff brush, a cleanser, and hot water. 10. Preheat the mold at approximately 388C (1008F) for 15 minutes to drive off the excess moisture and also aid in dissolving contaminants that may be present on the mold surface. Mix the tinted MDX 4-4210 Silicone with adhesive (Medical Adhesive Type A; Dow Corning Corp Medical Products) in the desired ratio (30% MDX; 70% Type A). Add additional kaolin and colorants to color correct the mixture to the originally mixed shade. Pack the perforated stone mold drag with the MDX 4-4210 Silicone/Medical Adhesive Type A mixture. Strop the material from one side to the other with a spatula without entrapping air. Close the cope to the drag with steady hand pressure to allow air to MAY 2004
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Fig. 7. Tracheostomy obturator in place.
escape through the perforations in the drag mold, decreasing void formation. Secure the mold with rubber bands, clamps, or press. Allow silicone to polymerize at room temperature for 24 hours. Recover the prosthesis. Trim off the excess flash with scissors (Castroviejo scissors; Hu-Friedy Mfg Inc, Chicago, Ill) and/or a sharp knife (Fig. 6). 11. Fit the tracheostomy obturator on the patient. Evaluate the prosthesis during speech, swallowing, and head and body movements; adjust where indicated. 12. Place an orientation mark on the intaglio surface of the prosthesis to prevent incorrect prosthesis orientation and placement problems. Have the patient rehearse prosthesis placement and removal in front of a mirror (Fig. 7). Instruct the patient on how to properly clean the prosthesis. 13. Fabricate several spare prostheses. Archive the mold for future prosthesis fabrication.
DISCUSSION The moulage of the tracheostoma can be performed under general anesthesia with endotracheal tube intubation via the oral cavity. Ensure the balloon cuff of the endotracheal tube is inflated below the tracheostoma. However, due to patient unconsciousness, muscle paralysis, and gravity (supine position), do not border mold the final moulage to achieve good adaptation. Use of a breathing tube in making the preliminary moulage is not needed due to the patient’s existing primary airway. Using a higher-viscosity impression material, such as putty, for the preliminary moulage provides better ease of handling properties, and decreases but does not eliminate risk of material aspiration. This type of impression material provides adequate preliminary impression tissue detail. If retention of the tracheostomy obturator is a problem, alter the MDX 4-420 Silicone/Medical Adhesive Type A ratio (40% MDX; 60% Type A) and 497
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fabricate a new prosthesis. If the problem persists, a suitable skin adhesive can be used to provide auxiliary retention. Multiple prostheses can be fabricated altering the MDX 4-420 Silicone/Medical Adhesive Type A ratio. In treating this patient, decreasing the Medical Adhesive Type A amount increased the flexibility of the prosthesis. This increased flexibility lessened the chance of the prosthesis becoming dislodged during muscle and body movements. It also decreased the prosthesis rigidity and lifespan. HAE patients wear the tracheostomy obturator 24 hours each day. The prosthesis should be removed and cleaned as the need arises. Proper head and body position should be stressed to help maintain retention of the prosthesis. Excessive mucous production and perspiration will adversely affect retentive qualities of skin adhesives if used. It is the authors’ experience and opinion that, due to material degradation, the lifespan of the prosthesis varies from every 6 months to 1 year (Fig. 8).
SUMMARY A clinical and laboratory technique for fabrication of a functional tracheostomy obturator for a hereditary angioneurotic edema patient with a permanent tracheostoma has been presented. The tracheostomy obturator greatly enhances the patient’s quality of life and, when removed, establishes a patent airway for breathing during a severe oropharyngeal angioedema episode. REFERENCES 1. Crowder JR, Crowder TR. Five generations of hereditary angioneurotic edema. Arch Intern Med 1917;20:840-52. 2. Ebo DG, Stevens WJ. Hereditary angioneurotic edema: review of the literature. Acta Clin Belg 2000;55:22-9. 3. Donaldson VH, Evans RR. A biochemical abnormality in hereditary angioneurotic edema: absence of serum inhibitor of C1-esterase. Am J Med 1963;31:37-44. 4. Israili ZH, Hall WD. Cough and angioneurotic edema associated with angiotensin-converting enzyme inhibitor therapy. A review of the literature and pathophysiology. Ann Intern Med 1992;117:234-42. 5. Sabroe RA, Black AK. Angiotensin-converting enzyme (ACE) inhibitors and angioedema. Br J Dermatol 1997;136:153-8. 6. Agostoni A, Cicardi M. Hereditary and acquired C1 inhibitor deficiency: biological and clinical characteristics in 235 patients. Medicine 1992;71:206-15. 7. Winnewisser J, Rossi M, Spath P, Burgi H. Type I hereditary angioedema. Variability of clinical presentation and course within two large kindreds. J Int Med 1997;241:39-46. 8. Frank MM, Gelfand JA, Atkinson JP. Hereditary angioedema: the clinical syndrome and its management. Ann Intern Med 1976;84:580-93.
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9. Cicardi M, Bergamaschini L, Marasini B, Boccassini G, Tucci A, Agostoni A. Hereditary angioedema: an appraisal of 104 cases. Am J Med Sci 1982;284:2-9. 10. Sim TC, Grant JA. Hereditary angioedema: its diagnostic and management perspectives. Am J Med 1990;88:656-64. 11. Schreiber AD, Kaplan AP, Austen KF. Inhibition by C1INH of Hageman factor fragment activation of coagulation, fibrinolysis and kinin generation. J Clin Invest 1973;52:1402-9. 12. Huston DP, Bressler RB. Urticaria and angioedema. Med Clin North Am 1992;76:805-40. 13. Osler W. Hereditary angioneurotic edema. Am J Med Sci 1888;93:362-7. 14. Cicardi M, Bergamaschini L, Cugno M, Beretta A, Zingale LC, Colombo M, et al. Pathogenic and clinical aspects of C1 inhibitor deficiency. Immunobiology 1998;199:366-76. 15. Spaulding WB. Methyltestosterone therapy for hereditary episodic edema (hereditary angioneurotic edema). Ann Intern Med 1960;53:739-45. 16. Waytes AT, Rosen FS, Frank MM. Treatment of hereditary angioedema with a vapor-heated C1 inhibitor concentrate. N Engl J Med 1996; 334:1630-4. 17. Kunschak M, Engl W, Maritsch F, Rosen FS, Eder G, Zerlauth G, et al. A randomized, controlled trial to study the efficacy and safety of C1 inhibitor concentrate in treating hereditary angioedema. Transfusion 1998; 38:540-9. 18. Visentin DE, Yang WH, Karsh J. C1-esterase inhibitor transfusions in patients with hereditary angioedema. Ann Allergy Asthma Immunol 1998;80:457-61. 19. Beumer J, Curtis TA, Marunick MT. Maxillofacial rehabilitation: prosthodontic and surgical considerations. 2nd ed. St. Louis: Medico Dental Media International; 1996. p. 514. 20. Rudd K, Morrow RM, Rosenthal DS. Prosthesis for the temporary closure of a tracheostomy stoma. J Prosthet Dent 1966;16:1159-61. 21. Harley WT, Rothwell KS. Fabrication of tracheotomy prostheses. J Prosthet Dent 1971;22:679-84. 22. Moore DJ. Cervical esophagus prosthesis. J Prosthet Dent 1973;30:442-5. 23. Grisius RJ, Moore DJ, Simpkins WT Jr. Prosthetic treatment of the laryngectomized patient. J Prosthet Dent 1974;32:300-6. 24. Light J, Silverman SI, Garfinkel L. The use of an intraoral training aid in the speech rehabilitation of laryngectomy patients. J Prosthet Dent 1976; 35:430-40. 25. Shedd DP, Schaaf NG, Kielich M. A prosthetic device for air-tunnel speech rehabilitation. J Prosthet Dent 1976;36:82-7. 26. Andres CJ, Newton AD, Cantu E. A custom speech valve retainer for the laryngectomee. J Prosthet Dent 1987;57:208-14. 27. Jacob RF, Bowman JB. A custom tracheostoma valve retainer for the laryngectomy patient. J Prosthet Dent 1987;57:479-82. 28. Meyer JB, Knudson RC. Fabrication of a custom recessed tracheostoma valve retainer for the total laryngectomy patient. J Prosthet Dent 1990;63:182-6. 29. Smith RM, Sutton AJ, Hansen NA. Custom retainer for the Blom-Singer adjustable tracheostoma valve. J Prosthet Dent 2000;84:341-4. Reprint requests to: DR MARTY G. MOON 1219 CARTLEY COURT WOODBINE, MD 21797 FAX: (202) 782-6987 E-MAIL: [email protected] 0022-3913/$30.00
doi:10.1016/j.prosdent.2004.02.010
VOLUME 91 NUMBER 5
H
ereditary angioneurotic edema (HAE), also known as congenital C1-inhibitor deficiency, is a rare autosomal dominant complement–mediated disease.1,2 Activation of the complement system increases vascular permeability.3 C1-esterase inhibitor (C1-INH) suppresses activation of the complement system and decreases vascular permeability.3 In HAE, the activation of the complement system cannot be inhibited due to the deficiency or alteration of the antigenic and/or functional C1-INH. The resulting increase in vascular permeability causes angioedema.3 Accumulation of bradykinin, not histamine, seems to be responsible for the activation of the complement system.4,5 Clinically, HAE is characterized by recurrent circumscribed, nonpitting, and nonpruritic subepithelial swellings of sudden onset, which can be fully manifested within a few hours.6,7 Its presentation has been observed to diminish during the course of 48 to 72 hours, but it can persist up to 1 week.6,7 Lesions can be solitary or multiple and primarily involve the extremities, larynx, face, and bowel wall. The bronchial trees are never involved in attacks of HAE.2 The frequency and severity of attacks varies considerably and may fluctuate over time. Well-known precipitating events are mental and physical stress, minor trauma, insect stings, food, alcohol, dental or surgical procedures, infections, and trivial activities such as typing, prolonged writing, pushing a lawn mower, hammering or standing in place for a few hours.3,6-10 In about half of reported instances, a precipitating event cannot be identified.6,10 Many The opinions or assertions herein are the private view of the authors and are not to be construed as official or reflecting the views of the Department of Defense. Identification of commercial materials and equipment in this report does not imply official recommendation or endorsement or that the materials and equipment are necessarily the best available for the purpose. a Colonel, US Army Dental Corps; Chief, Department of Maxillofacial Prosthetics, Walter Reed Army Medical Center. b Captain, US Navy; Chairperson, Department of Maxillofacial Prosthetics, National Naval Dental Center. c Dental Technician 2nd Class, US Navy; Section Leader, Department of Maxillofacial Prosthetics, National Naval Dental Center. d Dental Technician 2nd Class, US Navy; Department of Maxillofacial Prosthetics, National Naval Medical Center.
494 THE JOURNAL OF PROSTHETIC DENTISTRY
times HAE resolves without harm; however, laryngeal or tracheal angioedema may result in asphyxiation, which remains the major cause of death.3,6-13 Before the advent of therapy, mortality resulting from asphyxiation was as high as 30%.6,8,9,13 Three distinct phases in the management of HAE are recognized: (1) treatment of exacerbation, (2) shortterm prophylaxis, and (3) maintenance therapy.10,12 Exacerbation is managed by supportive therapy with particular attention to maintaining an airway. Severe oropharyngeal angioedema may necessitate emergency intubation and/or tracheostomy, and such patients are monitored closely in a hospital setting until the attack resolves.12 Prophylactic administration of either attenuated androgens or protease inhibitors has proven useful in reducing frequency or severity of attacks.6,7,12 The current treatment of choice for acute attacks of HAE is replacement therapy with purified vapor-heated C1INH, as it is safe and effective for both preventing and treating attacks.6,14-18 Rarely, due to a high frequency of HAE attacks, severe laryngeal angioedema, significant adverse effects from antifibrinolytic drugs, and noncompliance with taking medications, patients may request a permanent tracheostoma (Fig. 1).8 For these patients, the tracheostoma provides a patent airway for breathing when they experience a severe oropharyngeal angioedema episode. HAE patients with a tracheostoma can benefit from the fabrication of a tracheostomy obturator. There are several benefits of the tracheostomy obturator. It functions to prevent healing by primary intention, prevent stenosis of the tracheostoma, improve cosmetics, restore speech function, restore the airway particle filtration system, increase airway resistance for adequate exchange of gases in the lungs, increase heating and humidification of the inhaled air, and improve patient’s psyche for coping with the disease, and it can be removed quickly to obtain a patent airway when the patient experiences a severe oropharyngeal angioedema episode. Techniques for the fabrication of the tracheostomy obturator have been described in the literature.19-21 Rudd et al20 used alginate impression material to obtain VOLUME 91 NUMBER 5
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THE JOURNAL OF PROSTHETIC DENTISTRY
2.
3.
Fig. 1. Anterior view of tracheostoma.
an impression of the defect and employed safeguards in case of accidental aspiration of the impression material. The obturator was fabricated out of a flexible resin and was used for approximately 2 months. At the end of the 2-month period, the patient’s condition had improved, and surgical closure was complete. Harley and Rothwell21 fabricated molds from stainless steel tracheotomy tubes of various diameters in reversible hydrocolloid and poured autopolymerizing acrylic resin in the molds. The obturators were employed in situations where the original tracheotomy tube was removed but where it was not totally certain that the patient would continue to breathe independently of the tracheal opening. Once the obturator was no longer required, different obturators of decreasing diameter were employed to accommodate for normal healing and closure. Impression technique and fabrication of a custom tracheostoma valve retainer for a laryngectomy patient closely mirrors the technique used for fabricating a tracheostomy obturator.22-29 However, a patient breathes primarily through the custom tracheostoma valve retainer, and the tracheostomy obturator provides an emergency airway if the primary airway is constricted or blocked by severe laryngeal angioedema. The goal in fabricating a tracheostomy obturator is to provide retention of the prosthesis through muscle contraction and an intimate fit with the internal surface of the trachea, thereby limiting it from becoming dislodged by any excessive patient body movements. This article describes a technique for fabrication of a custom tracheostomy obturator for an HAE patient with a permanent tracheostoma.
4.
5.
TECHNIQUE 1. Perform the moulage-making procedures in a hospital clinical setting with a head and neck surgeon available to manage a possible airway emergency. Ensure the presence of the dental high-speed MAY 2004
6.
evacuation system and a tracheostomy tube in the event of accidental aspiration of impression material. Seat the patient in an upright position. Make the preliminary moulage of the tracheostoma and surrounding tissue using vinyl polysiloxane (VPS) putty (Exaflex; GC America Inc, Alsip, Ill). Mold the putty gently around the surrounding soft tissues and slightly into the tracheostoma. Box and pour the preliminary moulage in Type V dental stone (Die-Keen Green; Heraeus Kulzer Inc, South Bend, Ind). Fabricate a custom acrylic resin tray (Fastray; Bosworth Co, Skokie, Ill) that extends 2 to 3 cm beyond the tracheostoma margins. Design the custom tray with a handle on the cameo surface and 4 tissue stops positioned quadrilaterally, 2 cm from the margins of the defect, on the intaglio surface. Use 24-gauge relief metal (Grobet USA, Carlstadt, NJ) and 2 layers of baseplate wax (Medium Soft Pink Wax No. 3; Hygenic Corp, Akron, Ohio) as a spacer. At chairside, practice placing the impression tray in the proper position as oriented from the moulage cast. Remove the relief metal and wax spacer. Place multiple perforations in the tray with a round bur (no. 6; Midwest Dental Products Corp, Des Plaines, Ill) to allow release of impression material hydrostatic pressure and adhesion. Paint VPS adhesive (Universal VPS Adhesive; GC America Inc) on the tray. Spread the approximate volume of impression material simulating the previously removed wax (spacer), and place impression material around the tray to contact the tracheostoma. Make the intermediate moulage with VPS light or medium body impression material (Examix, GC America Inc), ensuring the impression material flows away from the tracheostoma to prevent aspiration of material. Remove the VPS impression material from the part of the custom tray touching and extending into the tracheostoma. Add mouth-temperature wax (Adaptol; J.F. Jelenko, Armonk, NY) to the areas where the VPS was removed. Ask the patient to functionally mold the wax with head and shoulder movements, swallowing, and speech articulations. Perform this step in a hospital clinical setting with a head and neck surgeon available to manage a possible airway emergency. Add wax in small increments to prevent breakage and possible tracheal aspiration of wax. Evaluate wax impression for fit and seal before each wax addition. Stop making the wax impression of the tracheostoma when there is a continuous, uniformly smooth surface (Fig. 2). Chill the completed wax impression in ice water. Box the definitive functional moulage. Sharpen the ends of approximately 20, 4-inch–long, 495
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Fig. 2. Intaglio view of definitive moulage with wax impression.
Fig. 3. Occlusal view of perforated stone mold drag.
Fig. 4. Skin surface characteristics on wax surface.
Fig. 5. Occlusal view of stone mold cope.
.036-inch–diameter, standard round, stainless steel, orthodontic wires (3M Unitek, Monrovia, Calif). Lubricate the wires with a stone-separating medium or tin foil substitute. Perforate the impression with the wires. Align wire parallel to the height of the boxing wax (Dental Boxing Wax; Moyco Union Broach, York, Pa). Pour the final functional moulage in Type V dental stone. After the dental stone has set for 48 hours, place the attached moulage to the stone complex in a water bath. Heat the water bath to 498 to 538C (1208 to 1308F) to soften the wax. Separate moulage from the undercuts without compromising the integrity of the cast. Remove the wires from the perforated stone mold drag (Fig. 3). Eliminate the undercuts just inside the tracheostoma orifice with blockout wax (Bellewax; Belle De St. Claire, Chatsworth, Calif). Burnish 24-gauge relief metal (Grobet USA) over the blockout wax and mold. Prepare a baseplate wax pattern on the mold. Remove pattern from the mold without breaking. Place additional blockout 496
wax in undercuts if the pattern breaks upon removal, and readapt the pattern to mold. 7. Evaluate the wax pattern on the patient for adequate fit, seal, and retention. Evaluate the patient and the mold to determine if increased retention is needed. Increase retention for the wax pattern by lightly scraping the undercut areas in the stone mold and readapting the wax pattern. 8. Begin tinting and custom intrinsic staining of the prosthesis. Mix silicone (MDX 4-4210 Silicone; Dow Corning Corp Medical Products, Midland, Mich) with 10% kaolin by weight, without catalyst. Tint the MDX 4-4210 Silicone using the various colorants, flocking, and earth pigments to match the patient’s skin tone to establish the base shade for the prosthesis. 9. Index keyways with a laboratory carbide bur (Goldies Shape B ½; Dedeco Int Inc, Long Eddy, NY) in a dental lathe (Baldor Polishing Lathe; Baldor Electric Co, Ft Smith, Ariz) in the perforated stone mold drag, and seal the wax VOLUME 91 NUMBER 5
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Fig. 6. Properly trimmed tracheostomy obturator.
Fig. 8. Prosthesis (>1 year wear) post placement demonstrating color change and loss of marginal adaptation.
pattern. Develop skin surface characteristics on the wax surface (Fig. 4). Apply a tin foil substitute. Box and pour with Type V dental stone to form the cope portion of the stone mold (Fig. 5). Allow the stone to set for 48 hours, then separate, trim, and boil out wax residue. Clean the mold surfaces using a stiff brush, a cleanser, and hot water. 10. Preheat the mold at approximately 388C (1008F) for 15 minutes to drive off the excess moisture and also aid in dissolving contaminants that may be present on the mold surface. Mix the tinted MDX 4-4210 Silicone with adhesive (Medical Adhesive Type A; Dow Corning Corp Medical Products) in the desired ratio (30% MDX; 70% Type A). Add additional kaolin and colorants to color correct the mixture to the originally mixed shade. Pack the perforated stone mold drag with the MDX 4-4210 Silicone/Medical Adhesive Type A mixture. Strop the material from one side to the other with a spatula without entrapping air. Close the cope to the drag with steady hand pressure to allow air to MAY 2004
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Fig. 7. Tracheostomy obturator in place.
escape through the perforations in the drag mold, decreasing void formation. Secure the mold with rubber bands, clamps, or press. Allow silicone to polymerize at room temperature for 24 hours. Recover the prosthesis. Trim off the excess flash with scissors (Castroviejo scissors; Hu-Friedy Mfg Inc, Chicago, Ill) and/or a sharp knife (Fig. 6). 11. Fit the tracheostomy obturator on the patient. Evaluate the prosthesis during speech, swallowing, and head and body movements; adjust where indicated. 12. Place an orientation mark on the intaglio surface of the prosthesis to prevent incorrect prosthesis orientation and placement problems. Have the patient rehearse prosthesis placement and removal in front of a mirror (Fig. 7). Instruct the patient on how to properly clean the prosthesis. 13. Fabricate several spare prostheses. Archive the mold for future prosthesis fabrication.
DISCUSSION The moulage of the tracheostoma can be performed under general anesthesia with endotracheal tube intubation via the oral cavity. Ensure the balloon cuff of the endotracheal tube is inflated below the tracheostoma. However, due to patient unconsciousness, muscle paralysis, and gravity (supine position), do not border mold the final moulage to achieve good adaptation. Use of a breathing tube in making the preliminary moulage is not needed due to the patient’s existing primary airway. Using a higher-viscosity impression material, such as putty, for the preliminary moulage provides better ease of handling properties, and decreases but does not eliminate risk of material aspiration. This type of impression material provides adequate preliminary impression tissue detail. If retention of the tracheostomy obturator is a problem, alter the MDX 4-420 Silicone/Medical Adhesive Type A ratio (40% MDX; 60% Type A) and 497
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fabricate a new prosthesis. If the problem persists, a suitable skin adhesive can be used to provide auxiliary retention. Multiple prostheses can be fabricated altering the MDX 4-420 Silicone/Medical Adhesive Type A ratio. In treating this patient, decreasing the Medical Adhesive Type A amount increased the flexibility of the prosthesis. This increased flexibility lessened the chance of the prosthesis becoming dislodged during muscle and body movements. It also decreased the prosthesis rigidity and lifespan. HAE patients wear the tracheostomy obturator 24 hours each day. The prosthesis should be removed and cleaned as the need arises. Proper head and body position should be stressed to help maintain retention of the prosthesis. Excessive mucous production and perspiration will adversely affect retentive qualities of skin adhesives if used. It is the authors’ experience and opinion that, due to material degradation, the lifespan of the prosthesis varies from every 6 months to 1 year (Fig. 8).
SUMMARY A clinical and laboratory technique for fabrication of a functional tracheostomy obturator for a hereditary angioneurotic edema patient with a permanent tracheostoma has been presented. The tracheostomy obturator greatly enhances the patient’s quality of life and, when removed, establishes a patent airway for breathing during a severe oropharyngeal angioedema episode. REFERENCES 1. Crowder JR, Crowder TR. Five generations of hereditary angioneurotic edema. Arch Intern Med 1917;20:840-52. 2. Ebo DG, Stevens WJ. Hereditary angioneurotic edema: review of the literature. Acta Clin Belg 2000;55:22-9. 3. Donaldson VH, Evans RR. A biochemical abnormality in hereditary angioneurotic edema: absence of serum inhibitor of C1-esterase. Am J Med 1963;31:37-44. 4. Israili ZH, Hall WD. Cough and angioneurotic edema associated with angiotensin-converting enzyme inhibitor therapy. A review of the literature and pathophysiology. Ann Intern Med 1992;117:234-42. 5. Sabroe RA, Black AK. Angiotensin-converting enzyme (ACE) inhibitors and angioedema. Br J Dermatol 1997;136:153-8. 6. Agostoni A, Cicardi M. Hereditary and acquired C1 inhibitor deficiency: biological and clinical characteristics in 235 patients. Medicine 1992;71:206-15. 7. Winnewisser J, Rossi M, Spath P, Burgi H. Type I hereditary angioedema. Variability of clinical presentation and course within two large kindreds. J Int Med 1997;241:39-46. 8. Frank MM, Gelfand JA, Atkinson JP. Hereditary angioedema: the clinical syndrome and its management. Ann Intern Med 1976;84:580-93.
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9. Cicardi M, Bergamaschini L, Marasini B, Boccassini G, Tucci A, Agostoni A. Hereditary angioedema: an appraisal of 104 cases. Am J Med Sci 1982;284:2-9. 10. Sim TC, Grant JA. Hereditary angioedema: its diagnostic and management perspectives. Am J Med 1990;88:656-64. 11. Schreiber AD, Kaplan AP, Austen KF. Inhibition by C1INH of Hageman factor fragment activation of coagulation, fibrinolysis and kinin generation. J Clin Invest 1973;52:1402-9. 12. Huston DP, Bressler RB. Urticaria and angioedema. Med Clin North Am 1992;76:805-40. 13. Osler W. Hereditary angioneurotic edema. Am J Med Sci 1888;93:362-7. 14. Cicardi M, Bergamaschini L, Cugno M, Beretta A, Zingale LC, Colombo M, et al. Pathogenic and clinical aspects of C1 inhibitor deficiency. Immunobiology 1998;199:366-76. 15. Spaulding WB. Methyltestosterone therapy for hereditary episodic edema (hereditary angioneurotic edema). Ann Intern Med 1960;53:739-45. 16. Waytes AT, Rosen FS, Frank MM. Treatment of hereditary angioedema with a vapor-heated C1 inhibitor concentrate. N Engl J Med 1996; 334:1630-4. 17. Kunschak M, Engl W, Maritsch F, Rosen FS, Eder G, Zerlauth G, et al. A randomized, controlled trial to study the efficacy and safety of C1 inhibitor concentrate in treating hereditary angioedema. Transfusion 1998; 38:540-9. 18. Visentin DE, Yang WH, Karsh J. C1-esterase inhibitor transfusions in patients with hereditary angioedema. Ann Allergy Asthma Immunol 1998;80:457-61. 19. Beumer J, Curtis TA, Marunick MT. Maxillofacial rehabilitation: prosthodontic and surgical considerations. 2nd ed. St. Louis: Medico Dental Media International; 1996. p. 514. 20. Rudd K, Morrow RM, Rosenthal DS. Prosthesis for the temporary closure of a tracheostomy stoma. J Prosthet Dent 1966;16:1159-61. 21. Harley WT, Rothwell KS. Fabrication of tracheotomy prostheses. J Prosthet Dent 1971;22:679-84. 22. Moore DJ. Cervical esophagus prosthesis. J Prosthet Dent 1973;30:442-5. 23. Grisius RJ, Moore DJ, Simpkins WT Jr. Prosthetic treatment of the laryngectomized patient. J Prosthet Dent 1974;32:300-6. 24. Light J, Silverman SI, Garfinkel L. The use of an intraoral training aid in the speech rehabilitation of laryngectomy patients. J Prosthet Dent 1976; 35:430-40. 25. Shedd DP, Schaaf NG, Kielich M. A prosthetic device for air-tunnel speech rehabilitation. J Prosthet Dent 1976;36:82-7. 26. Andres CJ, Newton AD, Cantu E. A custom speech valve retainer for the laryngectomee. J Prosthet Dent 1987;57:208-14. 27. Jacob RF, Bowman JB. A custom tracheostoma valve retainer for the laryngectomy patient. J Prosthet Dent 1987;57:479-82. 28. Meyer JB, Knudson RC. Fabrication of a custom recessed tracheostoma valve retainer for the total laryngectomy patient. J Prosthet Dent 1990;63:182-6. 29. Smith RM, Sutton AJ, Hansen NA. Custom retainer for the Blom-Singer adjustable tracheostoma valve. J Prosthet Dent 2000;84:341-4. Reprint requests to: DR MARTY G. MOON 1219 CARTLEY COURT WOODBINE, MD 21797 FAX: (202) 782-6987 E-MAIL: [email protected] 0022-3913/$30.00
doi:10.1016/j.prosdent.2004.02.010
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