Cologne Merheim Hospital, Department of Pneumology, Kliniken der Stadt Köln gGmbH, Witten/Herdecke University, Cologne, Germany.
Department of Neurology and Neurophysiology, Helios Hospital Wuppertal, Witten/Herdecke University, Wuppertal, Germany.
Int J Chron Obstruct Pulmon Dis. 2021 Mar 26;16:771-781. doi: 10.2147/COPD.S289755. eCollection 2021.
The impact of oronasal and nasal masks on the quality of nocturnal non-invasive ventilation (NIV) needs to be clarified. This trial was designed to compare the impact of oronasal and nasal masks on the objective quality and subjective acceptance of nocturnal NIV in COPD-patients.
In a randomized crossover trial, 30 COPD-patients with well-established high-intensity NIV (mean inspiratory/expiratory positive airway pressure 26±3/5±1 cmHO, mean respiratory back-up rate 17±1/min) were ventilated for two consecutive nights on oronasal and nasal masks, respectively.
Full polysomnography, nocturnal blood gas measurements, and subjective assessments were performed. There was a tendency towards improved sleep efficiency (primary outcome) when an oronasal mask was worn (+9.9%; 95% CI:-0.2%-20.0%; =0.054). Sleep stages 3/4 were favored by the oronasal mask (+12.7%; 95% CI: 6.0%-19.3%; =<0.001). Subjective assessments were comparable with the exception of items related to leakage (<0.05 in favor of nasal masks). The mean transcutaneous PCO value for oronasal masks (47.7±7.4 mmHg) was comparable to that of nasal masks (48.9±6.6 mmHg) (=0.11). There was considerable diversity amongst individual patients in terms of sleep quality and gas exchange following mask exchange. Subjective mask preference was not associated with sleep quality, but with nocturnal dyspnea. Over 40% of patients subsequently switched to the mask that they were not previously accustomed to.
In general, oronasal and nasal masks are each similarly capable of successfully delivering NIV in COPD-patients. However, the individual response to different interfaces is extremely heterogeneous, while subjective mask preference is independent from objective measures, but associated with dyspnea.
German Clinical Trials Registry (DRKS00007741).
需要阐明口鼻面罩和鼻面罩对夜间无创通气（NIV）质量的影响。本试验旨在比较口鼻面罩和鼻面罩对 COPD 患者夜间 NIV 的客观质量和主观接受度的影响。
在一项随机交叉试验中，30 名 COPD 患者在接受高强度 NIV（平均吸气/呼气正压 26±3/5±1cmHO，平均后备呼吸频率 17±1/min）治疗后，连续两晚分别使用口鼻面罩和鼻面罩进行通气。
进行了全睡眠多导图、夜间血气测量和主观评估。与佩戴鼻面罩相比，佩戴口鼻面罩时睡眠效率有改善的趋势（主要结局）（+9.9%；95%CI：-0.2%-20.0%；=0.054）。口鼻面罩更有利于睡眠阶段 3/4（+12.7%；95%CI：6.0%-19.3%；<0.001）。除与泄漏相关的项目外（<0.05，鼻面罩更优），主观评估结果相似。口鼻面罩的平均经皮 PCO 值（47.7±7.4mmHg）与鼻面罩（48.9±6.6mmHg）相当（=0.11）。在更换面罩后，患者的睡眠质量和气体交换存在很大的个体差异。主观面罩偏好与睡眠质量无关，但与夜间呼吸困难有关。超过 40%的患者随后改用他们之前不习惯的面罩。
总的来说，口鼻面罩和鼻面罩在 COPD 患者中均能成功地提供 NIV。然而，不同接口的个体反应差异很大，而主观面罩偏好与客观测量无关，但与呼吸困难有关。
德国临床试验注册（DRKS00007741）。
