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临床试验/NCT05425836
NCT05425836已完成不适用

A Randomized Controlled Trial to Compare High Flow Nasal Cannula With Standard Nasal Cannula to Prevent Desaturation in Subjects Undergoing Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA)

Post Graduate Institute of Medical Education and Research, Chandigarh4 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
4
主要终点
proportion of subjects experiencing oxygen desaturation events

研究概览

简要总结

Endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (TBNA) is a routine procedure that is performed to sample mediastinal lymph nodes. At author's center the EBUS-TBNA procedure is performed under conscious sedation using midazolam. During the EBUS procedure, oxygen supplementation can either be provided using low flow or high flow through a nasal cannula.

The investigators hypothesize that the use of high flow nasal cannula (HFNC) for oxygen supplementation during EBUS would be associated with lesser incidence of clinically significant hypoxemia (SpO2 ≤90%) when compared to conventional nasal cannula. In this study, the authors plan to assess the efficacy of HFNC in reducing the incidence of hypoxemic events in subjects undergoing EBUS under conscious sedation.

详细描述

Endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (TBNA) is a routine procedure that is performed to sample mediastinal lymph nodes. The procedure is performed either under conscious sedation or using general anaesthesia. At author's center the EBUS-TBNA procedure is performed under conscious sedation using midazolam.During the EBUS procedure, oxygen supplementation is provided to prevent desaturation events. However, despite oxygen supplementation previous studies have reported fall in pulse oximetric saturation (SpO2) below 90%.

The high-flow nasal cannula (HFNC) is a novel device for providing oxygen supplementation. It delivers a flow of 10-70 litres/min of humidified, warmed 100% oxygen through a nasal cannula. The device has been used extensively in intensive care setting in adults with hypoxemic respiratory failure. In a study conducted on patients undergoing EBUS-TBNA, the use of HFNC led to a significant reduction in the number of subjects experiencing clinically significant hypoxemia (SpO2 ≤90%) compared to conventional oxygen supplementation. However, the study conclusions were limited by a small sample size. Another study demonstrated lesser episodes of hypoxemia with HFNC compared to the conventional oxygen supplementation. This study also had a small sample size (n=40). The investigators that the use of HFNC for oxygen supplementation during EBUS would be associated with lesser incidence of clinically significant hypoxemia (SpO2 ≤90%) when compared to conventional nasal cannula. In this study, the authors intend to assess the efficacy of HFNC in reducing the incidence of hypoxemic events in subjects undergoing EBUS under conscious sedation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1. All adult (aged between 18 and 80 years) subjects undergoing the EBUS-TBNA procedure and pulse oximetric SPO2 ≥95% at room air will be eligible for this study

排除标准

  • oxygen supplementation required to achieve SPO2 >95%;
  • subjects who have altered mentation;
  • failure to provide informed consent

结局指标

主要结局

proportion of subjects experiencing oxygen desaturation events

时间窗: 1 hour (during the EBUS procedure)

oxygen desaturation events (defined SpO2 \<90% for at least 10 seconds) during the EBUS-TBNA procedure

次要结局

  • number of desaturation events (SPO2 <90% for at least 10 seconds) during the procedure(1 hour (during the EBUS procedure))
  • nadir SPO2 level during the procedure(1 hour (during the EBUS procedure))
  • patient comfort and bronchoscopist satisfaction score(1 hour (during the EBUS procedure))
  • SPO2 after pre-oxygenation(1 hour (during the EBUS procedure))
  • number of participants experiencing complications in each group(1 hour (during the EBUS procedure))

研究者

发起方
Post Graduate Institute of Medical Education and Research, Chandigarh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Inderpaul singh

Assistant Professor

Post Graduate Institute of Medical Education and Research, Chandigarh

研究点 (4)

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