title: Randomised, multi-centre study of the usefulness of the heat and moisture exchanger (Provox HME®) in laryngectomised patients.
abstract: 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.
authors.affiliation: Département de Chirurgie ORL et Cervico-faciale, Centre Antoine Lacassagne, Centre régional de lutte contre le cancer, Nice Cedex 2, France. olivier.dassonville@nice.fnclcc.fr
authors.forename: Olivier
authors.initials: O
authors.lastname: Dassonville
authors.forename: Jean Claude
authors.initials: JC
authors.lastname: Mérol
authors.forename: Alexandre
authors.initials: A
authors.lastname: Bozec
authors.forename: François
authors.initials: F
authors.lastname: Swierkosz
authors.forename: José
authors.initials: J
authors.lastname: Santini
authors.forename: André
authors.initials: A
authors.lastname: Chaïs
authors.forename: Pierre Yves
authors.initials: PY
authors.lastname: Marcy
authors.forename: Paul
authors.initials: P
authors.lastname: Giacchero
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Chamorey
authors.forename: Gilles
authors.initials: G
authors.lastname: Poissonnet
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006813:Humidity; D007825:Laryngectomy / Q000534:rehabilitation*; D007831:Larynx, Artificial; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010699:Phonation / Q000502:physiology*; D011446:Prospective Studies; D011474:Prosthesis Design; D011788:Quality of Life; D016896:Treatment Outcome; D014833:Voice Quality / Q000502:physiology*