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临床试验/NCT03129217
NCT03129217已完成不适用

The Validity of Maximal Diaphragm Thickening Fraction to Measure Diaphragm Function in Mechanically Ventilated Patients

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2015年11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
29
试验地点
2
主要终点
Maximal diaphragm thickening fraction

研究概览

简要总结

This study is designed to determine whether maximal diaphragm thickening fraction measured by ultrasound during volitional maximal inspiratory efforts is a valid measure of diaphragm function in mechanically ventilated patients.

详细描述

Classically, assessing diaphragm function requires direct measurements of transdaphragmatic pressure generation. A critical requirement for valid measurements is a maximal volitional patient effort. An alternative is to standardize the stimulus to the diaphragm using magnetic twitch stimulation fo the phrenic nerve. This is the gold standard technique for diaphragm function measurement in the respiratory physiology laboratory.

Twitch measurements require technical expertise and expensive equipment; this technique is therefore basically limited to the laboratory. Bedside ultrasonography has been proposed as a method for measuring diaphragm function by assessing the thickening of the muscle during a maximal inspiratory effort. In order to achieve a maximal volitional effort in mechanically ventilated patients, several methods may be employed: coached maximal efforts, coached sniffing, and transient airway occlusion to stimulate respiratory drive (Marini maneuver).

The investigators are evaluating the validity of diaphragm functional assessment using bedside ultrasound in combination with coached efforts/sniffing/Marini maneuver against the gold standard technique: twitch transdiaphragmatic pressure.

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

入选标准

  • Adult patients (≥ 18 years old) with acute respiratory failure receiving invasive mechanical ventilation via endotracheal tube or tracheostomy
  • Patients who meet readiness-to-wean criteria (triggering the ventilator; FiO2 ≤ 50%; PEEP ≤ 8 cm H20; hemodynamic stability)

排除标准

  • Contraindication to phrenic nerve stimulation (chest tube; cardiac pacemaker or implanted defibrillator; cervical implants; use of neuromuscular blocking agents within the 24 hours preceding the first diaphragm assessment (with the exception of succinylcholine used during rapid-sequence induction of anaesthesia for intubation); cervical spine injury; known pregnancy)
  • Patients experiencing an acute exacerbation of an obstructive lung disease (chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis)

结局指标

主要结局

Maximal diaphragm thickening fraction

时间窗: On day of study

Diaphragm ultrasound to measure thickening fraction

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor
主要研究者

Ewan Goligher

Clinical Associate

University Health Network, Toronto

研究点 (2)

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