Provox Life HMEs for Pulmonary Rehabilitation in HME-Naïve Laryngectomy Patients: A Randomized Controlled Trial
In brief
After laryngectomy, Provox Life users had half as many forced expectorations at nine months
In a randomized trial of 79 HME-naive patients, those using Provox Life wore the devices for nearly 24 hours a day. At nine months, they averaged 3.3 forced expectorations per day, versus 6.6 in controls, and reported clinically meaningful symptom improvements and better sleep. The two-center trial supports benefit, but longer-term outcomes remain unknown.
- Journal
- Laryngoscope investigative otolaryngology (Q2)
- Published
- 27 September 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Rafael De Cicco, Rafael Pereira de Souza, Carla Gonçalves Soares Moreira, Sandra Lopez Calcines, Victor Bandini Vieira, Daniela Maria Santos Serrano Marquezin, et al.
- PMID
- 42802786
- DOI
- 10.1002/lio2.70576
Why clinicians should know about it
- Picked for Otorhinolaryngology (top studies of the week, 4 October 2026): Provox Life improves pulmonary symptoms post‑laryngectomy
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.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.