跳至主要内容
临床试验/CTRI/2025/10/095695
CTRI/2025/10/095695尚未招募不适用

Comparison and correlation between occlusion pressure with diaphraghmatic thickening fraction versus occlusion pressure with diaphraghmatic excursion in predicting successful extubation in critically ill patients - A Randomized clinical study

Department of Critical Care Medicine1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年10月23日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
To assess the correlation between the diaphragmatic thickness fraction , Diaphraghmatic excursion and P0.1 in the assessment of patients’ contribution in mechanical ventilation.

研究概览

简要总结

P0.1(Airway occlusion pressure) is the
static pressure generated by all inspiratory muscles against an occluded
airway at 0.1s after the onset of inspiration. It is independent of any
mechanical load, and it is independant of respiratory system mechanics[1].
P0.1in spontaneous breathing is reliable even in cases of critical illness
myopathy of the respiratory muscles. In healthy adults the
normal values are in the range of 0.5 to 1.5 cm H2O.

In COPD , it ranges from 2-5 cm H2O. Any value above 3.5 cm H2O in mechanically ventilated patients is considered as increased respiratory muscle effort. Values of 3 to 6 cm H2O are recorded among patients undergoing ventilation for ARDS, whereas values as high as 13 cmH2O have been recorded during weaning. Its limitations are it may dissociate from the actual respiratory drive in case of auto peep, nonintubated patients, and it may also vary based on the algorithm used to calculate the p0.1.

Ultrasound of the diaphragm is a non-invasive, straightforward procedure that is highly reproducible in the same individuals. As a result of its extensive usage, several criteria for diaphragmatic ultrasonography have been defined, including diaphragm excursion (DE) and diaphragm thickening fraction (DTF). Bedside assessment of the measurements of diaphragm thickening during inspiration (i.e, thickening fraction ) with ultrasound, can be used to assess the inspiratory efforts during respiration. It correlates with the diaphragmatic pressure-time product(PTP) and can be considered as a low cost, noninvasive method for the evaluation of respiratory drive.

The existing few literature comparing P0.1 with diaphragmatic USG have been done without randomization. To various biases and confounding factors, we will be doing this study by randomization and blinding.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • patients willing to give consent Respiratory failure with mechanical ventilation more than 24 hours The ability to tolerate spontaneous breathing trial for more than 1 hour.

排除标准

  • Neuromuscular diseases or 2.Diaphragmatic paralysis and 3.Tracheostomized patients.
  • 4.Recent thoracoabdominal surgeries, 5.Morbidly obese patients, 6.Hemodynamically unstable patients, 7.Hhigh positive end expiratory pressure (PEEP) and intrinsic PEEP.

结局指标

主要结局

To assess the correlation between the diaphragmatic thickness fraction , Diaphraghmatic excursion and P0.1 in the assessment of patients’ contribution in mechanical ventilation.

时间窗: 0,12,24 hours

次要结局

  • Extubation success, duration of mechanical ventilation, length of ICU and hospital stays.(days)

研究者

发起方
Department of Critical Care Medicine
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Sathya Narayanan K

Bangalore Medical College and Research Institute

研究点 (1)

Loading locations...

相似试验