Laryngoscope investigative otolaryngology · 2026
Provox Life HMEs for Pulmonary Rehabilitation in HME-Naïve Laryngectomy Patients: A Randomized Controlled Trial.
СтатьяНазвание и аннотация: Перевод в очереди
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De Cicco Rafael, de Souza Rafael Pereira, Moreira Carla Gonçalves Soares, Calcines Sandra Lopez, Vieira Victor Bandini, Marquezin Daniela Maria Santos Serrano, Nakai Marianne Yumi, Menezes Marcelo Benedito, Milan Tabata Briaunys, Dias Francisco Araújo
Аннотация
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.
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.