Département de physiologie, explorations fonctionnelles, unité des pathologies du sommeil, AP-HP, Hôpital Raymond Poincaré, 104, boulevard Raymond-Poincaré, 92380 Garches, France; Université Versailles - Saint-Quentin-en-Yvelines, «End:icap» U1179 Inserm, UFR Des sciences de la sante - Simone-Veil, Versailles, France.
University Grenoble Alpes, Inserm, CHU Grenoble Alpes, HP2, 38000 Grenoble, France; AGIR à dom. Association, Meylan F-38240, France.
Arch Bronconeumol (Engl Ed). 2021 Apr;57(4):273-280. doi: 10.1016/j.arbres.2020.05.024. Epub 2020 Jun 23.
Around 25% of patients with neuro-muscular diseases (NMD) are treated by home noninvasive ventilation (NIV) through an oronasal mask. However, there is growing evidence that nasal masks require lower NIV pressures and result in fewer residual obstructive events. We hypothesized that nasal masks would improve efficacy and reduce side effects compared to oronasal masks in this population.
open label, cross-over, randomized, study in 2 tertiary care hospitals. Patients with NMD treated by home NIV were randomized for one-week periods to nasal and oronasal interfaces respectively (cross-over). At the end of each period, nocturnal polygraphy (monitoring mouth opening) under NIV, synchronized with transcutaneous partial pressure in CO (tcCO) was performed. Data were collected from the NIV built-in software and NIV side-effects were collected. Intention-to-treat and per protocol analyses were performed. The primary outcome was mean nocturnal SpO. The secondary outcomes were: percentage of sleep with SpO<90%, oxygen desaturation index (ODI), mean tcCO, mean duration of mouth opening during sleep, level of non-intentional leaks and side-effects.
Thirty patients with NMD were included. There were no between-group differences for either the primary or secondary outcomes. Post hoc comparisons showed that changing between interfaces reduced NIV efficacy: mean nocturnal SpO (p=0.04), ODI (p=0.01), mean tcCO2 (p=0.048), side-effects (p=0.008).
Nasal masks did not improve NIV efficacy or reduce side effects compared to oronasal masks in patients with NMD treated by home NIV. The efficacy of NIV is reduced during the transition to another interface, requiring close monitoring. Registration number: NCT03458507.
约 25%的神经肌肉疾病（NMD）患者通过口鼻面罩接受家庭无创通气（NIV）治疗。然而，越来越多的证据表明，与口鼻面罩相比，鼻罩需要更低的 NIV 压力，并且导致更少的残留阻塞性事件。我们假设在该人群中，与口鼻面罩相比，鼻罩将提高疗效并减少副作用。
在 2 家三级护理医院进行开放标签、交叉、随机研究。通过家庭 NIV 治疗的 NMD 患者被随机分为鼻罩和口鼻面罩组，各进行为期一周的治疗（交叉）。在每个治疗周期结束时，在 NIV 下进行夜间多导睡眠图（监测口张开度），同时监测经皮二氧化碳分压（tcCO）。数据从 NIV 内置软件和 NIV 副作用收集器中收集。采用意向治疗和方案分析。主要结局是夜间平均 SpO。次要结局是：睡眠中 SpO<90%的百分比、氧减指数（ODI）、平均 tcCO、睡眠中口张开的平均持续时间、非意愿性漏气水平和副作用。
共纳入 30 例 NMD 患者。主要或次要结局均无组间差异。事后比较显示，在接口之间切换会降低 NIV 疗效：夜间平均 SpO（p=0.04）、ODI（p=0.01）、平均 tcCO2（p=0.048）、副作用（p=0.008）。
与口鼻面罩相比，NMD 患者接受家庭 NIV 治疗时，鼻罩并未提高 NIV 疗效或减少副作用。在转换到另一个接口时，NIV 的疗效会降低，需要密切监测。注册号：NCT03458507。
