Abstract

Background: Active humidification is commonly suggested for long-term NIV. However its impacts on NIV compliance, quality of life (QoL) and NIV efficacy have not been assessed. Methods: Randomised controlled monocentric trial conducted between 05/2018 and 01/2019 that included all patients referred for home NIV initiation. Patients were randomised to have their NIV setup with a humidification device (HD group) or without (control group). Outcomes were assessed 2 months following NIV initiation. Results: Thirty-three patients were included in the trial. They had a mean age of 66±12 years. Underlying respiratory disease was: obesity hypoventilation syndrome (n:12), COPD (n:8), neuromuscular/chest-wall disease (n:8) and COPD-OSA (n:5). At baseline, there was no difference between both groups. Final assessments were available at follow-up: 14 in the HD group and 16 in the control group. At follow-up, compliance was: 5.7±3.3 in the HD group and 5.3±1.6hours/day in the control group (p:0.683). Improvement in QoL assessed by the Severe Respiratory Insufficiency questionnaire was: +5±24 in the HD group vs -11±22 in the control group (p:0.125). Improvement in daytime PaCO2 was: -0.36±0.87 in the HD group vs -0.02±0.68 kPa in the control group (p:0.260). Perceived mouth dryness assessed by visual analogue scale was: 6.1±2.7 out of 10 in the HD group and 6.3±3.1 in the control group (p:0.869). Conclusion: Active humidification does not improve compliance, efficacy of NIV nor QoL. These data need to be confirmed on a larger population.

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