It was a triple-arm, open-label, randomised controlled trial. Ninety patients with COPD were randomly assigned into three intervention arms in 1:1:1 ratio. The incidence of hypoxia, lowest recorded oxygen saturation measured by plethysmography (SpO2), ECG, patient vitals and comfort levels were assessed.
Mean age of the study population was 61.71±7.5 years. Out of 90 cases enrolled, 51, 34 and 5 were moderate, severe and very-severe COPD, respectively, as per GOLD (Global Initiative for Chronic Obstructive Lung Disease) classification. Rest of the baseline characteristics were similar. SpO2 during flexible bronchoscopy (FB) was lowest in COT group (COT: 87.03±5.7% vs HFOT: 95.57±5.0% vs NIV: 97.40±1.6%, p<0.001). Secondary objectives were similar except respiratory-rate (breaths-per-minute) which was highest in COT group (COT: 20.23±3.1 vs HFOT: 18.57±4.1 vs NIV: 16.80±1.9, p<0.001). Whereas post FB partial of oxygen in arterial blood was highest in NIV group (NIV: 84.27±21.6 mm Hg vs HFOT: 69.03±13.6 mm Hg vs COT: 69.30±11.9 mm Hg, p<0.001). Post FB partial pressure of carbon dioxide in arterial blood was similar in the three arms. Operator\'s ease-of-performing-procedure was least in the NIV group as assessed with Visual Analogue Scale (p<0.01). A higher number of NIV group participants reported nasal pain as compared with the other two arms (p<0.01).
NIV and HFOT are superior to COT in preventing hypoxia during bronchoscopy, but NIV is associated with poor patient-tolerance and inferior operator\'s ease of doing procedure.
CTRI/2021/03/032190.
方法:这是一个三臂,开放标签,随机对照试验。90例COPD患者以1:1:1的比例被随机分配到三个干预组。缺氧的发生率,通过体积描记术(SpO2)测量的最低记录氧饱和度,心电图,评估患者生命体征和舒适度.
结果:研究人群的平均年龄为61.71±7.5岁。在90例登记病例中,51、34和5为中度,严重和非常严重的COPD,分别,根据GOLD(全球慢性阻塞性肺疾病倡议)分类。其余的基线特征相似。COT组柔性支气管镜(FB)期间的SpO2最低(COT:87.03±5.7%vsHFOT:95.57±5.0%vsNIV:97.40±1.6%,p<0.001)。次要目标相似,但呼吸频率(每分钟呼吸)在COT组中最高(COT:20.23±3.1vsHFOT:18.57±4.1vsNIV:16.80±1.9,p<0.001)。而FB后动脉血中的部分氧气在NIV组中最高(NIV:84.27±21.6mmHgvsHFOT:69.03±13.6mmHgvsCOT:69.30±11.9mmHg,p<0.001)。三臂中动脉血中二氧化碳的FB后分压相似。根据视觉模拟评分法评估,NIV组中操作员的操作简便程度最低(p<0.01)。与其他两组相比,NIV组参与者报告鼻痛的人数更高(p<0.01)。
结论:NIV和HFOT在预防支气管镜检查期间的缺氧方面优于COT,但NIV与较差的患者耐受性和较差的操作者操作容易程度有关。
背景:CTRI/2021/03/032190。