University of Leipzig, Leipzig, Germany.
Hospital Emden, Bolardusstrasse 20, 26721, Emden, Germany.
Trials. 2022 Jan 10;23(1):28. doi: 10.1186/s13063-021-05978-z.
Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) have a major negative impact on health status, rates of hospitalization, readmission, disease progression and mortality. Non-invasive ventilation (NIV) is the standard therapy for hypercapnic acidotic respiratory failure in AECOPD. Despite its beneficial effects, NIV is often poorly tolerated (11-34 % failure rate). An increasing number of studies have documented a beneficial effect of nasal high-flow (NHF) in acute hypercapnia. We designed a prospective, randomized, multi-centre, open label, non-inferiority trial to compare treatment failure in nasal NHF vs NIV in patients with acidotic hypercapnic AECOPD.
The study will be conducted in about 35 sites in Germany. Patients with hypercapnic AECOPD with respiratory acidosis (pH < 7.35) will be randomized 1:1 to NIV or NHF. The primary outcome is the combined endpoint of intubation, treatment failure or death at 72 h. The switch from one to the other device marks a device failure but acts as a rescue treatment in absence of intubation criteria. A sample size of 720 was calculated to have 80% power for showing that NHF is non-inferior to NIV with a margin of 8 percentage points. Linear regression will be used for the confirmatory analysis.
If NHF is shown to be non-inferior to NIV in acidotic hypercapnic AECOPD, it could become an important alternative treatment.
ClinicalTrials.gov , NCT04881409 , Registered on May 11, 2021.
慢性阻塞性肺疾病（COPD）急性加重（AECOPD）对健康状况、住院率、再入院率、疾病进展和死亡率有重大负面影响。无创通气（NIV）是治疗 AECOPD 合并高碳酸血症酸中毒呼吸衰竭的标准疗法。尽管 NIV 具有有益的效果，但常常不能被很好地耐受（失败率为 11-34%）。越来越多的研究记录了鼻塞高流量（NHF）在急性高碳酸血症中的有益作用。我们设计了一项前瞻性、随机、多中心、开放标签、非劣效性试验，以比较 NHF 与 NIV 在合并酸中毒性高碳酸血症的 AECOPD 患者中的治疗失败率。
该研究将在德国约 35 个地点进行。将伴有呼吸性酸中毒（pH < 7.35）的高碳酸血症 AECOPD 患者随机分为 1:1 接受 NIV 或 NHF 治疗。主要结局是 72 小时时插管、治疗失败或死亡的联合终点。从一种设备切换到另一种设备标志着设备失败，但在没有插管标准的情况下作为一种抢救治疗。计算了 720 例的样本量，以 80%的效能显示 NHF 不劣于 NIV，差值为 8 个百分点。线性回归将用于确认性分析。
如果 NHF 在合并酸中毒性高碳酸血症的 AECOPD 中被证明不劣于 NIV，它可能成为一种重要的替代治疗方法。
ClinicalTrials.gov，NCT04881409，于 2021 年 5 月 11 日注册。
