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临床试验/CTRI/2022/03/040965
CTRI/2022/03/040965尚未招募不适用

Determination of parasternal intercostal muscle activity in critically ill patients with various weaning patterns and its association with weaning-induced pulmonary oedema (WIPO)

Souvik Chaudhuri1 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2022年3月25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
145
试验地点
1
主要终点
Successful weaning from ventilator

研究概览

简要总结

Mechanically ventilated patients who are fitting the inclusion and exclusion criteria will be included for this study. The duration of spontaneous breathing trial (SBT) will be 120 minutes as per the protocol at our institute. Just before initiation of SBT, the patient will be evaluated by bedside ultrasound for the lung ultrasound score for presence of pulmonary oedema, cardiac function ( systolic and diastolic function). Patients who tolerate at least 30 minutes of SBT will be evaluated for lung ultrasound for evidence of weaning induced pulmonary oedema (WIPO), bedside echocardiography (systolic and diastolic dysfunction) and parasternal muscle thickening and parasternal muscle thickening fraction. Diaphragmatic excursion and diaphragmatic thickening fraction will also be noted.

At the end of 120 minutes of SBT, whether or not the patients are getting successfully off ventilator support as per the treating intensivist, will be noted.

The patients who fail even 30 minutes of SBT, the following parameters will be noted after the patient is put back on previous ventilatory support as per the treating intensivist- lung ultrasound for evidence of pulmonary oedema, systolic and diastolic function as per echocardiography. The patients who fail SBT for the first time, will be followed for the subsequent 3 SBT for the same parameters as outlined above for the first SBT. The number of SBT required for successful weaning from ventilator will be noted.

Patients who are removed from ventilator after SBT success at 120 minutes will be followed for next 48 hours to see if they require invasive ventilator support/ intubation again.

Outcome of the ICU stay at 28 days will be noted - survival or mortality.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Patients who were mechanically ventilated in ICU and meet the following criteria will be put on SBT for weaning will be included.
  • Following will be the criteria to consider for weaning in the ICU which is used by any intensivist at our institute:
  • Fraction of inspired oxygen (FiO2 < 0.5)
  • Positive end expiratory pressure (PEEP) ≤ 5cmH2O
  • Partial pressure of oxygen in arterial blood (PaO2)/FiO2 > 150 mmHg
  • Respiratory rate < 35/minute
  • Tidal volume >5mL /kg,
  • Minute ventilation < 10L/min
  • No abnormality in electrolyte parameters, absence of hemodynamic instability, resolution of the initial cause of ventilator requirement and patients awake with the ability to cough.

排除标准

  • Patients with chest wall abnormalities,
  • Distorted chest wall anatomy,
  • Patients with any known neuromuscular weakness,
  • Patients with any known diaphragmatic disorders
  • Pregnant patients,
  • Patients with known cardiac dysfunction on initial ECHO during hospital admission
  • Any patient in whom the SBT is aborted even before 30 minutes duration as deemed by the intensivist will be excluded.

结局指标

主要结局

Successful weaning from ventilator

时间窗: 48 hours after removal of ventilator

次要结局

  • Survival of ICU stay(28 days from day of admission to ICU)

研究者

发起方
Souvik Chaudhuri
申办方类型
Other [Other (Self)]

研究点 (1)

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