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临床试验/NCT06445049
NCT06445049尚未招募不适用

Assessing Intrinsic Respiratory Rate in Mechanically Ventilated Adult Patients With Reverse Triggering as an Incentive for Accelerating Transition to Spontaneous Breathing and Extubation: Pilot Randomized Clinical Trial - INTRINSIC

Unity Health Toronto0 个研究点目标入组 70 人开始时间: 2024年7月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
主要终点
Number of patients tolerating the transition to assisted breathing, or having an SBT, or being extubated within 48 hours

研究概览

简要总结

The goal of this study is to identify patients with reverse triggering who's the potential to breath spontaneously is hidden because of the ventilator management strategy by performing a simple 30sec-test with includes reducing the support from the ventilator. The findings will provide clear advice to doctors on how to better care for these patients.

This will be a pilot randomized clinical trial including 70 adult patients (aimed at equal number of men and woman) sedated and under controlled ventilation having reverse triggering. The study will be conducted in two ICUs: 1) St. Michael's Hospital, Toronto Canada and 2) Toronto Western Hospital, Toronto, Canada.

详细描述

The objective of this study is to investigate the impact of assessing intrinsic respiratory rate in mechanically ventilated patients with reverse triggering on the facilitation of transition to spontaneous breathing and successful extubation.

Patients will be excluded if under current use of continuous neuromuscular blocking agent or severe metabolic acidosis (Ph<7.25 at the time of study procedure.

Patients will be screened every morning from 8:00 am to 9:00 am all the patients under controlled ventilation to detect the presence of reverse triggering by looking at the screen on the ventilator (2-5 min observation). The research team (research MDs, physiotherapists and respiratory therapists) is very well trained at detecting reverse triggering. Patients will then be randomized to standard of care or intervention using a deferred consent model.

  • Control group: standard care.
  • Intervention group: The intervention is a simple brief test as follows: With the ventilator set with the patient clinical settings, it will be performed an up to 30sec-long or two inspiratory effort and expiratory occlusion maneuver on the ventilator and/or switch the patient to pressure support for up to 30sec-long to assess the presence of intrinsic respiratory rate.

If an intrinsic respiratory rate ≥8 breaths per minute is present and P/F ratio is ≥150 it will be performed a 5-minute "test" in pressure support ventilation with the pressure support level to match the clinical setting of the patient. If the patient tolerates well 5 minutes in pressure support (see criteria below) the clinical team will be informed:

研究设计

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

入排标准

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

入选标准

  • Adult patients (aimed at equal number of men and woman) sedated and under controlled ventilation having reverse triggering.

排除标准

  • under current use of continuous neuromuscular blocking agent or severe metabolic acidosis (Ph<7.25) at the time of study procedure.

结局指标

主要结局

Number of patients tolerating the transition to assisted breathing, or having an SBT, or being extubated within 48 hours

时间窗: 48 hours

Number of patients tolerating the transition to assisted breathing (e.g., Pressure Support Ventilation, Neurally Adjusted Ventilatory Assist, Proportional assist ventilation with load-adjustable gain factors), or having an SBT, or being extubated within 48 hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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