Prediction of Successful Liberation From Invasive Mechanical Ventilation Via Lung and Diaphragmatic Ultrasound in Intensive Care Unit Patients, Prospective, Observational Study

Completed

• Conditions: Liberation From Mechanical Ventilation in ICU Patients
• Interventions: Other: Sonographic evaluation of diaphragm and lung

• Registration Number: NCT06461754
• Lead Sponsor: Sohag University

Brief Summary

Liberation from invasive mechanical ventilation (IMV) remains a challenge for intensive care physicians. Although standard indices such as blood gases and respiratory clinical data are used routinely but they still have some limitations. Diaphragmatic and lung sonographic parameters (pulmonary scores) recently became the hot spot to help in anticipation of liberation from IMV.The aim of this study was to ensure that, sonographic diaphragmatic thickening indices and lung scores are reliable and accurate additional tools to anticipate successful liberation from IMV in intensive care unit (ICU) patients.

Methods: This study was a prospective, observational study conducted at Sohag university hospital on 80 patients admitted to the Intensive Care Unit (ICU) and mechanically ventilated invasively for more than 24 hours and they were ready for weaning by standard methods. At the time of spontaneous breathing trials (SBT), we did diaphragm and lung ultrasound, where we applied diaphragmatic thickening indices (DTI) and a modified lung ultrasound scores (LUSm). Patients classified into two groups; failed group (FG) and (SG) of liberation from IMV. Comparison between (FG) and (SG) in relation to pulmonary scores (DTI and LUSm) were recorded. Cut-off values, sensitivity and specificity for DTI and LUSm were obtained. Also, comparison between (FG) and (SG) in relation to demographic, clinical and respiratory data were assessed and all data were statistically analysed.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-21
• Primary Completion: 2023-10-20
• Study Completion: 2023-12-20
• Status Verified: 2024-06
• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-06-11
• Study First Posted: 2024-06-17
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Over 18 years of age, more than 24 hours on IMV, and prepared for weaning

Exclusion Criteria

• A spinal cord injury that exceeded T8, arrhythmias, heart failure, hemodynamic instability, terminal extubation, pregnancy, pneumothorax, pneumomediastinum, COPD, thoracostomy, chest injuries that impeded ultrasound, pleural lesions, or neuromuscular diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Succeeded Group (SG)	Sonographic evaluation of diaphragm and lung	Group of patients who succeeded weaning from mechanical ventilation
Failed Group (FG)	Sonographic evaluation of diaphragm and lung	Group of patients who failed weaning from mechanical ventilation

Primary Outcome Measures

Name	Time	Method
a cut off values for DTI and LUSm with sensitivity and specificity for anticipation of liberation from invasive mechanical ventilation	One year	we reporte a cut-off value for DTI and LUSm below or above which the risk for failure of weaning can be predicted with a sensitivity persent and a specificity persent.

Secondary Outcome Measures

Name	Time	Method
The correlations of DTI and LUSm with demographic, clinical and respiratory data	one year	We recorded the relations of DTI and LUSm with demographic, clinical and respiratory data in prediction of succeeded liberation from IMV

Trial Locations

Locations (1)

Sohag University Hospital; 🇪🇬 Sohag, Egypt