BACKGROUND: Previous work from this department has shown that resistive tracheostomy filters increase the partial pressure of oxygen in capillary blood and also provide a significant amount of heat/moisture exchange. Until now it has not been shown whether there is any long-term beneficial effect and in particular whether raised tissue oxygenation is maintained using a practical filter device. METHODS: We carried out a 6-month randomized control trial including 50 laryngectomees. Twenty-five patients were treated with the Liverpool Heat Moisture Exchange device incorporating an airway resistor (Trachinaze). Another 25 patients were treated with a placebo device. Relevant subjective and objective data were collected before and at the end of the study. The objective measurements were capillary oxygen tension (which parallels blood arterial tension), carbon dioxide tension, FEV(1), FVC, and PIF. Patients were reviewed at intervals throughout the study. Data were analyzed using the Mann-Whitney U test and the paired t test to test the difference between the active device and placebo at 6 months. RESULTS:Subjective lower airway parameters, including cough, number of chest infections, mucus production, and shortness of breath at rest, were significantly improved in the active group compared with the placebo group. The objective parameters FEV(1), FVC, and PIF were not significantly different. Capillary oxygen tension, however, was highly significantly raised in the active group at 6 months. CONCLUSIONS:Trachinaze is highly superior to placebo at improving subjective pulmonary parameters, including shortness of breath. It is also superior in its ability to maintain an increased peripheral tissue oxygen tension over a 6-month period. Copyright 2003 Wiley Periodicals, Inc.
RCT Entities:
BACKGROUND: Previous work from this department has shown that resistive tracheostomy filters increase the partial pressure of oxygen in capillary blood and also provide a significant amount of heat/moisture exchange. Until now it has not been shown whether there is any long-term beneficial effect and in particular whether raised tissue oxygenation is maintained using a practical filter device. METHODS: We carried out a 6-month randomized control trial including 50 laryngectomees. Twenty-five patients were treated with the Liverpool Heat Moisture Exchange device incorporating an airway resistor (Trachinaze). Another 25 patients were treated with a placebo device. Relevant subjective and objective data were collected before and at the end of the study. The objective measurements were capillary oxygen tension (which parallels blood arterial tension), carbon dioxide tension, FEV(1), FVC, and PIF. Patients were reviewed at intervals throughout the study. Data were analyzed using the Mann-Whitney U test and the paired t test to test the difference between the active device and placebo at 6 months. RESULTS: Subjective lower airway parameters, including cough, number of chest infections, mucus production, and shortness of breath at rest, were significantly improved in the active group compared with the placebo group. The objective parameters FEV(1), FVC, and PIF were not significantly different. Capillary oxygen tension, however, was highly significantly raised in the active group at 6 months. CONCLUSIONS: Trachinaze is highly superior to placebo at improving subjective pulmonary parameters, including shortness of breath. It is also superior in its ability to maintain an increased peripheral tissue oxygen tension over a 6-month period. Copyright 2003 Wiley Periodicals, Inc.
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