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临床试验/NCT04971148
NCT04971148终止不适用

Correlation of Peak Tidal Inspiratory Flow Measured Before and After Extubation in Adult Patients With Hypoxemia, and Patients' Responses to Different Flows Above Their Peak Tidal Inspiratory Flow During High Flow Nasal Cannula Therapy

Rush University Medical Center2 个研究点 分布在 2 个国家目标入组 5 人开始时间: 2022年4月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
5
试验地点
2
主要终点
SpO2/FIO2

研究概览

简要总结

In this study, patients who are ready for extubation and indicated for high-flow nasal cannula therapy after extubation will be enrolled, the investigators would measure the patient peak tidal inspiratory flow (PTIF) pre and post extubation to explore the correlation between the two PTIFs. Moreover, different HFNC flows would be applied, to explore the patient response in terms of oxygenation and lung aeration to different flow ratios that matched and are above post-extubation PTIF.

详细描述

High-flow nasal cannula (HFNC) oxygen therapy has been shown to improve oxygenation, reduce the need for intubation for patients with acute hypoxemic respiratory failure (AHRF) and avoid reintubation for post-extubation patients who had high-risk factors. HFNC refers to the delivery of gas at flows that exceed the patient peak inspiratory flow during tidal breathing, However, patient peak tidal inspiratory flow (PTIF) is found to vary greatly among different patients, from 20 to 50 L/min, making it difficult to properly set HFNC in a way to achieve the desired effects. In two recently published studies in intubated patients, PTIF varied from 25-65 L/min or 40-80 L/min, thus this study aims to investigate the correlation between pre-extubation PTIF in different modalities of SBT and post-extubation PTIF for adult patients, who are indicated to use HFNC immediately after extubation. In addition, the investigators aim to explore the patient response in terms of oxygenation and lung aeration to different flow ratios that matched and are above post-extubation PTIF.

研究设计

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

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult intubated patients aged between 18 to 90 years
  • •Pass spontaneous breathing trial and receive the order to be extubated
  • •Have at least one of the indications to use HFNC after extubation

排除标准

  • •Need to use inhaled epoprostenol via HFNC
  • •Unable to use resuscitation mask, such as facial trauma, claustrophobia
  • •Non-English speaker
  • •Inability to verbally communicate
  • •Using extracorporeal membrane oxygenation (ECMO)
  • •Hemodynamically unstable
  • •Difficult airway

研究组 & 干预措施

HFNC flow set at 1.67 times of patient peak tidal inspiratory flow

Experimental

HFNC flow will be set at the level that is 1.67 times of patient peak tidal inspiratory flow

干预措施: HFNC flow set at 1.67 times of patient peak tidal inspiratory flow (Other)

HFNC flow set at patient peak tidal inspiratory flow

Active Comparator

HFNC flow will be set at the level that matches patient peak tidal inspiratory flow

干预措施: HFNC flow set at patient peak tidal inspiratory flow (Other)

HFNC flow set at 1.33 times of patient peak tidal inspiratory flow

Experimental

HFNC flow will be set at the level that is 1.33 times of patient peak tidal inspiratory flow

干预措施: HFNC flow set at 1.33 times of patient peak tidal inspiratory flow (Other)

HFNC flow set at 2 times of patient peak tidal inspiratory flow

Experimental

HFNC flow will be set at the level that is 2 times of patient peak tidal inspiratory flow

干预措施: HFNC flow set at 2 times of patient peak tidal inspiratory flow (Other)

结局指标

主要结局

SpO2/FIO2

时间窗: 20 minutes after each flow setting

Twenty mins after each flow setting, pulse oximetry divided by fraction of inspired oxygen will be used to assess patient's oxygenation response to different flow

次要结局

  • End-expiratory lung volume assessed by EIT(20 minutes after each flow setting)
  • self-evaluated comfort(20 minutes after each flow setting)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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