跳至主要内容
临床试验/CTRI/2024/12/078805
CTRI/2024/12/078805尚未招募不适用

Prediction of Weaning Outcome by Diaphragmatic Surface Electromyography: A Prospective Observational Study

Dr. Souvik Maitra1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2025年2月3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
129
试验地点
1
主要终点
To determine whether non- invasively measured diaphragmatic surface electromyography (sEMG) is useful in predicting weaning failures within 48 hours of extubation in critically ill patients.

研究概览

简要总结

All patients who satisfy the inclusion criteria will be included in the study after obtaining a written informed consent from the patients next of kin. When an SBT is planned by the treating physician, the investigator will perform the ultrasound measurements. First, the patients’ demographic characters like age, sex, nature of ICU (Medical /Surgical), presence of comorbid condition, primary diagnosis of the patient, indication of ICU admission, APACHE II and SOFA scores at ICU admission, duration of ICU stay, duration of mechanical ventilation prior to the SBT will be recorded. Baseline hemodynamic parameters such as heart rate (HR), systolic blood pressure (SBP), mean arterial pressure (MAP), diastolic blood pressure (DBP), oxygen saturation (SpO2), type of respiratory support, PaO2/FiO2 ratio, cumulative fluid balance after ICU admission at the time will also be noted.

Immediately before SBT, sEMG of diaphragm will be noted from two surface electrode by a commercially available sEMG device (PheezeeⓇ, Sartoon Labs). Another sets of reading of sEMG will be obtained as the end of SBT protocol irrespective of the decision of extubation. All patients will be followed 48 hours after extubation to note requirement of oxygen therapy (oxygen by face mask, non-invasive ventilation and HFNC) and requirement for re-intubation within 48 hours.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Critically ill patients with a diagnosis of respiratory failure, duration of mechanical ventilation of more than 48 hrs and eligible for a SBT as decided by the intensivist.

排除标准

  • Pregnancy
  • Patients with spinal cord injury
  • Presence of significant arrhythmias
  • Patients with diaphragmatic paralysis/injury.

结局指标

主要结局

To determine whether non- invasively measured diaphragmatic surface electromyography (sEMG) is useful in predicting weaning failures within 48 hours of extubation in critically ill patients.

时间窗: To determine whether non- invasively measured diaphragmatic surface electromyography (sEMG) is useful in predicting weaning failures within 48 hours of extubation in critically ill patients.

次要结局

  • 1. To determine the possibility of a composite index made up of patients demographic, baseline disease severity and fluid balance with diaphragmatic sEMG for predicting weaning outcomes.(2. To determine predictive ability of sEMG for SBT outcome.)

研究者

发起方
Dr. Souvik Maitra
申办方类型
Other [Principal Investigator]
责任方
Principal Investigator
主要研究者

Dr Souvik Maitra

All India Institute of Medical Sciences, New Delhi

研究点 (1)

Loading locations...

相似试验