跳至主要内容
临床试验/NCT06998927
NCT06998927进行中(未招募)不适用

Proportional Assist Ventilation Plus and Estimation of Respiratory Effort in Critically Ill Patients During the Transition to Spontaneous Ventilation: A Prospective Cohort Study

Argentinian Intensive Care Society1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
35
试验地点
1
主要终点
Correlation Between Ventilator-Measured Work of Breathing Tool and and invasive respiratory effort markers

研究概览

简要总结

In intensive care units, many critically ill patients need help from a machine called a ventilator to breathe. Once these patients start to recover, doctors try to gradually reduce this support and help them breathe on their own again. However, not all patients are ready to be taken off the ventilator right away. During this transition, it's important to find the right amount of help-enough to support their breathing, but not so much that the machine does all the work for them.

This study focuses on a special type of ventilator setting called Proportional Assist Ventilation Plus (PAV+). Unlike traditional modes, which give a fixed level of support, PAV+ adjusts the amount of help it gives based on how hard the patient is trying to breathe. The more effort a patient makes, the more support the machine provides-and vice versa. This can make breathing feel more natural and may protect the lungs and breathing muscles during recovery.

Modern ventilators also display a measurement called "Work of Breathing," which tells how much effort the patient is using to breathe. This study wants to find out whether this measurement from the ventilator is a reliable way to monitor a patient's breathing effort, compared to other more invasive or complex methods.

The research will include 20 adult patients who are recovering in the ICU and have been on mechanical ventilation for more than 48 hours. All patients will have already met some criteria showing they're ready to begin breathing more on their own, but are not quite ready to have the breathing tube removed.

Each patient will go through different levels of PAV+ support, and researchers will record how much effort they make to breathe using several methods, including special pressure sensors and data from the ventilator.

The goal of the study is to better understand how to measure breathing effort safely and easily, and to improve how we support patients as they recover the ability to breathe on their own. If successful, this could help reduce complications and improve recovery for people on ventilators.

There are no added risks or costs for the patients involved. All equipment used in the study is already part of regular ICU care. Participation requires informed consent and the privacy of all participants will be fully protected.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • •Adults (>18 yrs) requiring invasive MV >48 hrs
  • •Meeting spontaneous breathing transition criteria:
  • •Hemodynamic stability (NE <0.1 μg/kg/min)
  • •Spontaneous breathing efforts
  • •RASS -2 to +1
  • •FiO₂ <50% or PaO₂ >60mmHg with PEEP ≤10cmH₂O
  • •Pre-existing esophageal balloon
  • •Tolerates spontaneous modes >5 mins
  • •Signed informed consent

排除标准

  • •Meets extubation criteria
  • •Hemodynamic instability
  • •Psychomotor agitation (RASS >+1)
  • •Bronchopleural fistula
  • •Severe weakness (MRC <36)
  • •Neuromuscular disease
  • •Pregnancy

结局指标

主要结局

Correlation Between Ventilator-Measured Work of Breathing Tool and and invasive respiratory effort markers

时间窗: From enrollment to the end of measurents at 3 hours

Correlation between non-invasive WOB (measured by Puritan Bennett™ ventilators tool) and invasive metrics (Pes/PTPes via esophageal catheter, in cmH₂O and cmH₂O·s) during PAV+. Analyzed across 3 assistance levels (20%/50%/70%) to validate ventilator-based effort monitoring.

次要结局

  • Pocc (expiratory occlusion pressure in cmH₂O) during PAV+ analyzed across 3 assistance levels (20%/50%/70%) to validate ventilator-based effort monitoring.(From enrollment to the end of measurements at 3 hours)
  • P0.1 (inspiratory occlusion pressure at 100 mseg in cmH₂O) during PAV+ analyzed across 3 assistance levels (20%/50%/70%) to validate ventilator-based effort monitoring.(From enrollment to the end of measurements at 3 hours)

研究者

发起方
Argentinian Intensive Care Society
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gustavo Plotnikow

Head of Physical and Respiratory Care Department, ICU

Argentinian Intensive Care Society

研究点 (1)

Loading locations...

相似试验