Department of Pneumology, Cologne Merheim Hospital, Kliniken der Stadt Köln gGmbH, Witten/Herdecke University, Faculty of Health/School of Medicine, Cologne, Germany.
Clinical Trials Unit, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Respir Res. 2021 Apr 26;22(1):123. doi: 10.1186/s12931-021-01710-2.
Long-term non-invasive ventilation (NIV) is as an established treatment option for chronic hypercapnic COPD patients. Beneficial effects have also been shown during exercise, but this is restricted to rehabilitation programs. New portable NIV (pNIV) devices may now enable NIV application during walking at home.
In two randomized crossover trials, the impact of pNIV on dyspnea and endurance capacity was investigated in patients with moderate to severe COPD. Participants performed a standardized 6-min walking test, with and without pNIV, using a pre-set inspiratory/expiratory positive airway pressure of 18/8 cmHO. The first study was performed in NIV-naïve patients (Study I), while the second study was performed in those already established on long-term NIV (Study II).
38 patients (66.9 ± 7.4 years, mean FEV: 30.3 ± 8%pred) and 23 patients (67.6 ± 8.7 years, mean FEV: 29.8 ± 10.4%pred) participated in Study I and II, respectively. In Study I, the mean difference in the Borg Dyspnea Scale (BDS, primary outcome) score following walking was 3.2 (IQR 2-4) without pNIV, compared to 2.6 (IQR 1-4) with pNIV (ΔBDS 0.65, P = 0.04), while walking distance increased from 311.8 m (95%CI 276.9-346.6 m) to 326.3 m (95%CI 291.5-361.2 m) (P = 0.044) when pNIV was used. Accordingly, in Study II, the mean difference in BDS was 4.4 (IQR 3-6) without pNIV, compared to 4.5 (IQR 3-6) with pNIV (ΔBDS 0.09, P = 0.54), while walking distance decreased from 291.5 m (95%CI 246.1-336.9 m) to 258.4 m (95%CI 213-303.8 m) (P ≤ 0.001).
The use of a pNIV device during walking can improve dyspnea and walking distance in patients with moderate to severe COPD. Patients who do not already receive long-term NIV therapy are more likely to benefit compared to those undergoing long-term NIV. Careful patient selection is mandatory. Clinical Trial Register: DRKS00013203; DRKS00012913 registered October 20th 2017 and October 16th 2017; https://www.drks.de/drks_web/.
长期无创通气（NIV）是慢性高碳酸血症 COPD 患者的既定治疗选择。在运动期间也显示出了有益的效果，但这仅限于康复计划。新的便携式无创通气（pNIV）设备现在可能使在家中行走时能够应用无创通气。
在两项随机交叉试验中，研究了在中度至重度 COPD 患者中使用 pNIV 对呼吸困难和耐力的影响。参与者使用预设的吸气/呼气正压气道压力 18/8 cmHO 进行了标准化的 6 分钟步行测试，同时使用和不使用 pNIV。第一项研究是在 NIV 初治患者中进行的（研究 I），而第二项研究是在已经接受长期 NIV 治疗的患者中进行的（研究 II）。
38 名患者（66.9±7.4 岁，平均 FEV：30.3±8%pred）和 23 名患者（67.6±8.7 岁，平均 FEV：29.8±10.4%pred）分别参加了研究 I 和 II。在研究 I 中，在没有 pNIV 时，Borg 呼吸困难量表（BDS，主要结局）评分在行走后的平均差异为 3.2（IQR 2-4），而使用 pNIV 时为 2.6（IQR 1-4）（BDS 差异 0.65，P=0.04），而行走距离从 311.8 m（95%CI 276.9-346.6 m）增加到 326.3 m（95%CI 291.5-361.2 m）（P=0.044）。因此，在研究 II 中，在没有 pNIV 时，BDS 的平均差异为 4.4（IQR 3-6），而使用 pNIV 时为 4.5（IQR 3-6）（BDS 差异 0.09，P=0.54），而行走距离从 291.5 m（95%CI 246.1-336.9 m）减少到 258.4 m（95%CI 213-303.8 m）（P≤0.001）。
在行走过程中使用 pNIV 设备可以改善中重度 COPD 患者的呼吸困难和行走距离。与接受长期 NIV 治疗的患者相比，尚未接受长期 NIV 治疗的患者更有可能受益。必须对患者进行仔细选择。临床试验登记：DRKS00013203；DRKS00012913 于 2017 年 10 月 20 日和 2017 年 10 月 16 日注册；https://www.drks.de/drks_web/。
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