Effectiveness of automatically-adjusted vs manually-adjusted noninvasive ventilation in obesity hypoventilation syndrome: a randomized clinical trial.

Auto-adjusted NIV could obviate the need for polysomnographic titration, thereby reducing costs and delays in care.

自适应调节的NIV可能避免了多导睡眠图监测下的调节需求，从而降低了医疗成本并减少了治疗延迟。

However, non-inferiority long-term clinical trials comparing auto-adjusted NIV with manually-adjusted NIV are lacking.

然而，缺乏比较自动调整NIV与手动调整NIV的非劣效长期临床试验。

Background

To determine the comparative effectiveness of automatic vs manual NIV modality in OHS.

确定自动与手动NIV模式在OHS中的比较效果。

Methods

In this multicenter, blinded, parallel group, non-inferiority and cost-effectiveness trial, we randomly assigned treatment-naïve ambulatory patients with OHS to auto-adjusted NIV (volume-targeted pressure support with auto-expiratory positive airway pressure) or manually-adjusted NIV (bilevel Positive Airway Pressure Spontaneous Timed mode (PAP ST).

在这项多中心、盲法、平行组、非劣效性和成本效益试验中，我们随机分配了治疗前的门诊患者，这些患者患有OHS，分别接受自动调节NIV（目标体积压力支持与自动呼气正压）或手动调节NIV（双水平正压通气定时模式（PAP ST））。

measurements

The primary outcome was change in daytime PaCO2 at 12 months, with the non-inferiority premise set at -2 mm Hg.

主要结果是12个月时白天PaCO2的变化，非劣效性前提设定为-2 mm Hg。

Secondary outcomes included symptoms, quality of life, and healthcare resource utilization.

次要结果包括症状、生活质量以及医疗资源利用情况。

Intention-to-treatand per-protocol analyses were performed.

进行了意向治疗分析和按方案分析。

main_results

205 ambulatory patients with OHS were randomized, 107 to auto-adjusted NIV and 89 to manually-adjusted NIV.

205名门诊患者被随机分为两组，107名接受自动调节的NIV治疗，89名接受手动调节的NIV治疗。

The mean [95% CI] improvement in PaCO2 was -9.2 [-9.7; -8.7] mm Hg in the auto-adjusted group and -8.7 [-9.1; -8.3] mm Hg in the manually-adjusted group, with mean adjusted difference of 0.15 mm Hg between groups ([low confidence limit -1.4]; non-inferiority P = .01).

自动调节组的平均[95% CI]PaCO2改善为-9.2[-9.7; -8.7]mm Hg，手动调节组为-8.7[-9.1; -8.3]mm Hg，两组间平均调整差异为0.15 mm Hg（[低置信限-1.4]）；非劣效性P=0.01。

Cost-effectiveness was favorable to auto-adjusted group with a saving of 1528 € (95% CI, -2 370; -6 854) per patient.

自适应组的成本效益较好，每位患者节省了1528欧元（95%置信区间，-2370; -6854）。

There were no significant differences in other secondary outcomes.

其他次要结果没有显著差异。

Conclusions

In ambulatory patients with OHS, auto-adjusted NIV had a non-inferior long-term effectiveness compared to manually-adjusted NIV while being more cost-effective.

在门诊患有OHS的患者中，自动调整的NIV与手动调整的NIV相比，其长期有效性非劣效，同时更具成本效益。

Auto-adjusted NIV may be preferred in clinical practice given its lower complexity and cost.

鉴于其较低的复杂性和成本，自动调整的NIV在临床实践中可能更受青睐。

CLINICALTRIAL.GOV IDENTIFIER: NCT04327336.

临床试验注册号：NCT04327336。