Preventing oxygen desaturation during bronchoscopy in COPD patients using high flow oxygen versus standard management: the randomised controlled PROSA 2 Trial.
Andrei M Darie, Leticia Grize, Kathleen Jahn, Anna Salina, Jonathan Röcken, Matthias J Herrmann, Maria Pascarella, Vivian Suarez, Werner Strobel, Michael Tamm, Daiana Stolz
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引用次数: 0
Abstract
Background: Patients with chronic obstructive pulmonary disease (COPD) are at increased risk for developing additional respiratory comorbidities associated with smoking, and are thus prone to undergo flexible bronchoscopy. However, COPD patients have increased periprocedural complications risk and lower oxygen saturation during bronchoscopy.
Methods: This was an investigator-initiated, single centre, open-label randomised controlled trial designed to assess the benefits of high flow nasal oxygen compared to conventional low flow oxygen by nasal cannula during conscious sedation for bronchoscopy in patients with COPD. Low flow was supplied at a starting rate of 4 L / min and gradually increased up to 12 L / min to maintain the oxygen saturation (SpO2) above 90%. High flow delivered using LM Flow 100 (Löwenstein Medical GmbH, Bad Ems, Germany) starting at a rate of 60 L / min and an inspired fraction of oxygen (FiO2) of 0.6 was increased up to 80 L / min to preserve the SpO2 above 90%. The primary endpoint was cumulative hypoxaemia time.
Results: We randomised 600 COPD cases with a median age of 69.0 (62.0-76.0) years to either high flow (295) or low flow (305). The cumulative hypoxaemia time was 53% lower in the high flow group (1.8% [95%CI 1.5-2.2] versus 3.8% [95%CI 3.2-4.5] of monitoring time, p<0.001). Additionally, the high flow group experienced 3.0 (1.0-6.0) hypoxaemia events (SpO2<90%) as compared to 6.0 (3.0-10.0) in the low flow group (p<0.001). The low flow group had five-fold higher odds of experiencing hypoxaemia during bronchoscopy (OR 5.1 [95%CI 3.2-8.2], p<0.001).
Conclusion: High flow is feasible, decreases cumulative hypoxaemia time and reduces hypoxaemia events during bronchoscopy in patients with COPD but does not impact patient comfort.
Clinical trial registration: This trial was registered on the International Clinical Trials Registry Platform, ISRCTN18159882.
背景:慢性阻塞性肺疾病(COPD)患者发生与吸烟相关的其他呼吸道合并症的风险增加,因此易于接受柔性支气管镜检查。然而,COPD患者在支气管镜检查时术中并发症风险增加,血氧饱和度降低。方法:这是一项研究者发起的、单中心、开放标签的随机对照试验,旨在评估在COPD患者支气管镜检查的清醒镇静期间,高流量鼻吸氧与传统低流量鼻插管吸氧相比的益处。以4 L / min的启动速率提供低流量,逐渐增加至12 L / min,使氧饱和度(SpO2)保持在90%以上。使用LM flow 100 (Löwenstein Medical GmbH, Bad Ems, Germany)以60 L / min的速率开始高流量输送,吸入氧(FiO2) 0.6的分数增加到80 L / min,以保持SpO2高于90%。主要终点是累积低氧血症时间。结果:我们将600例中位年龄为69.0(62.0-76.0)岁的COPD患者随机分为高流量组(295)和低流量组(305)。高流量组累积低氧血症时间减少53% (1.8% [95%CI 1.5-2.2]与3.8% [95%CI 3.2-4.5]的监测时间相比)。结论:高流量是可行的,可减少COPD患者支气管镜检查期间累积低氧血症时间和低氧血症事件,但不影响患者舒适度。临床试验注册:本试验在国际临床试验注册平台ISRCTN18159882上注册。
期刊介绍:
The European Respiratory Journal (ERJ) is the flagship journal of the European Respiratory Society. It has a current impact factor of 24.9. The journal covers various aspects of adult and paediatric respiratory medicine, including cell biology, epidemiology, immunology, oncology, pathophysiology, imaging, occupational medicine, intensive care, sleep medicine, and thoracic surgery. In addition to original research material, the ERJ publishes editorial commentaries, reviews, short research letters, and correspondence to the editor. The articles are published continuously and collected into 12 monthly issues in two volumes per year.