Authors: Dassonville O, Merol JC, Bozec A, Swierkosz F, Santini J, Chais A, Marcy PY, Giacchero P, Chamorey E, Poissonnet G
Title: Randomised, multi-centre study of the usefulness of the heat and moisture exchanger (Provox HME®) in laryngectomised patients
Source: European Archives of Oto Rhino Laryngology 2011 268(11): 1647-1654
Year: 2011
Research Design: Randomised Controlled Trial
Rating Score: 03/10
This rating is confirmed
Eligibility specified - Y
Random allocation - Y
Concealed allocation - N
Baseline comparability - N
Blind subjects - N
Blind therapists - N
Blind assessors - N
Adequate follow-up - Y
Intention-to-treat analysis - N
Between-group comparisons - Y
Point estimates and variability - N

This study included 60 patients (30 in Nice and 30 in Reims), who were randomised between a control group that used no device of this type and a group equipped with the Provox HME®. After 3 months of using the device, a notable improvement was found which was statistically significant with regard to cough (P = 0.00174) and to bronchorrhoea (P = 0.0031), and very close to achieving significance with regard to breathing effort. An overall improvement in the prosthetic (tracheo-oesophageal) voice was found in the 21 patients using the HME® and a voice prosthesis for all of the parameters studied. The device was used daily by 80% of the patients of whom 42% used it day and night at the end of the 3 months. Seven patients suffered from minor cutaneous intolerance (of whom 6 had received radiation therapy), which did not require the use of the HME® to be abandoned (PC). After 3 months, patients were asked the following questions: "Do you feel any improvement?": 92% of affirmative answers; "Are you breathing better?": 88% of affirmative answers; "Are you speaking more easily?": 81% had experienced speech improvement. The general adaptation to the device was judged to be satisfactory for 95% of the patients after 3 months. The results of this randomised study show an improvement in the pulmonary symptoms and in the prosthetic voice after 3 months of using Provox HME®. This light and easy-to-use device appears to us to afford a significantly improved quality of life for laryngectomees and should be offered systematically during functional rehabilitation of these patients.

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