Provox Life
HMEs
for Pulmonary Rehabilitation in
HME
‐Naïve Laryngectomy Patients: A Randomized Controlled Trial
Rafael De Cicco, Rafael Pereira de Souza, Carla Gonçalves Soares Moreira, Sandra Lopez Calcines, Victor Bandini Vieira, Daniela Maria Santos Serrano Marquezin, Marianne Yumi Nakai, Marcelo Benedito Menezes, Tabata Briaunys Milan, Francisco Araújo Dias ABSTRACT
Objective
To evaluate whether Provox Life Heat and Moisture Exchangers (HMEs) and attachments enable HME‐naïve laryngectomized patients to establish a 24‐h HME routine, and whether the resulting effect on pulmonary symptoms is sustained over 9 months, compared with standard care.
Methods
In this prospective, randomized controlled trial, 79 HME‐naïve patients post‐total laryngectomy at two Brazilian centers were randomized to the Provox Life group ( n = 41) or a control group without HMEs ( n = 38). Data were collected at baseline and at 3, 6, and 9 months. The primary endpoint was the Cough Symptoms (COUS) domain of the validated Cough and Sputum Assessment Questionnaire (CASA‐Q). Secondary endpoints included other CASA‐Q domains, forced expectorations, involuntary coughs, sleep quality (JSEQ), quality of life (EQ‐5D‐5L), shortness of breath, skin integrity, pulmonary complications, and patient satisfaction.
Results
HME adherence was near‐continuous (mean 23.3–23.9 h/day). All four CASA‐Q domains (COUS, COUI, SPUS, SPUI) improved significantly from baseline in the Provox Life group (all p ≤ 0.001 at 9 months), with changes exceeding published minimal clinically important differences; controls remained stable except for transient sputum‐domain gains at T2. At 9 months, forced expectorations were significantly lower in the Provox Life group versus controls (3.3 ± 2.2 vs. 6.6 ± 6.1 per 24 h; p = 0.023). Sleep quality (JSEQ) improved significantly with Provox Life ( p = 0.013), but not in controls. The EQ‐5D‐5L index improved at 3 and 6 months, pulmonary complications were descriptively fewer, and 89.7% rated their experience “very good”. Skin irritation was low and comparable between groups. No device‐related serious adverse events occurred.
Conclusion
In HME‐naïve patients after total laryngectomy, Provox Life enables near‐continuous HME use and is associated with clinically meaningful improvements in pulmonary symptom burden, sputum management, and sleep quality. Skin tolerability is comparable to standard care.
Level of Evidence
1b
Trial Registration: ClinicalTrials.gov identifier: NCT06084611.