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临床试验/NCT05298319
NCT05298319已完成不适用

The 90% Effective Flow of High Flow Nasal Oxygenation During Deeply Sedated Bronchoscopy

Zhejiang Cancer Hospital1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
240
试验地点
1
主要终点
the incidence of hypoxemia

研究概览

简要总结

Patients undergoing sedated bronchoscopy were randomized into six groups (10 Liters/minute [L/min], 20 L/min, 30 L/min, 40 L/min, 50 L/min, 60 L/min). The primary outcome was the incidence of hypoxemia.

详细描述

It's a double-blind, randomized trial. The patients'demographic information, such as sex, weight, height, smoking status, present illness and history of past illness, were collected. After successful peripheral intravenous access, all patients, before sedation, received 20 min nebulization with lidocaine via a nebuliser facemask. The basic oxygen saturation, heart rate, and blood pressure of the patients were recorded by the investigators.Patients in the HFNO group received humidified oxygen at different rates via a high-flow nasal cannula (AIRVO2, New Zealand). After sedation with propofol and sufentanil, continuous electrocardiography and pulse oximetry were recorded, and the blood pressure of the patients was monitored throughout the procedure. . After bronchoscopy, patients were transferred to the post anesthesia care unit (PACU) if their vital signs were stable.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (1) undergoing sedated bronchoscopy
  • (2) 18 to 70 years of age;
  • (3) American Society of Anaesthesiologists (ASA) class: I-III

排除标准

  • (1) severe cardiac disease, including aortic stenosis, mitral stenosis, hemodynamic instability caused by severe arrhythmia, and acute myocardial infarction or cardiac surgery within the last 6 months;
  • (2) severe hypoxemia (SpO2 < 90% without oxygen supply on admission), caused by interstitial lung disease, end-stage chronic obstructive pulmonary disease (COPD) or other diseases;
  • (3) upper respiratory tract infection or lung infection;
  • (4) refusal to participate in this study.

结局指标

主要结局

the incidence of hypoxemia

时间窗: during bronchoscopy

hypoxemia was defined as SpO2 \< 90%

次要结局

  • jaw thrust maneuver(during bronchoscopy)
  • increase of flow rate(during bronchoscopy)
  • bag-mask ventilation(during bronchoscopy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wen Zhang

attending, principle investigator, department of anesthesiology

Zhejiang Cancer Hospital

研究点 (1)

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