Lung and Diaphragm Ultrasound in Predicting Extubation and Weaning of Mechanically Ventilated Patients in Intensive Care Unit

Completed

• Conditions: Lung; Diaphragm; Mechanically Ventilation; Ultrasound; Extubation; Weaning; Intensive Care Unit

• Registration Number: NCT07057804
• Lead Sponsor: Kafrelsheikh University

Brief Summary

This study aims to evaluate the role of lung ultrasound score (LUS), diaphragmatic excursion (DE), and diaphragmatic thickening fraction (DTF) as predictors of successful extubation in mechanically ventilated patients in the intensive care unit (ICU). It also compares these ultrasound-based parameters to traditional weaning criteria.

Detailed Description

Mechanical ventilation is a necessary life support technology for critically ill patients. The weaning outcome affects the morbidity and mortality of patients when their primary disease improves.

Moreover, lung ultrasonography can be used as an effective measure in the evaluation of lung aeration which is useful during the weaning procedure as it reflect the aeration loss and consequently predict the respiratory distress in the postintubation period, a validated score termed the lung ultrasound score(LUS) can be used to evaluate the loss of lung aeration.

Numerous data measured through diaphragmatic ultrasonography have been recommended for the same purpose, which involve measurement of diaphragmatic muscle movement during inspiration or excursion during the respiratory cycle (DE), and diaphragmatic muscle thickening or diaphragmatic thickening fraction (DTF).

Study Timeline

• Study Start: 2024-06-01
• Status Verified: 2025-06
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01
• Study First Submitted: 2025-06-30
• Study First Submitted QC: 2025-06-30
• Last Update Submitted: 2025-06-30
• Study First Posted: 2025-07-10
• Last Update Posted: 2025-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• All patients who will meet the following weaning criteria undergo Spontaneous Breathing Trial, which include,

  • Improvement of disease acute phase which necessitated mechanical ventilation.
  • Stable neurological status.
  • No hemodynamic instability (heart rate ≤ 120/min, systolic blood pressure higher than 90 mmHg and lower than 160 mmHg) in the absence of any vasoactive support therapy.
  • PaO2>60 mm Hg or SaO2 ≥ 90% or more with FiO2 ≤ 0.4.
  • Afebrile and there were no significant abnormalities in the electrolyte levels.

Exclusion Criteria

• Hemodynamic unstable patients
• Patients with severe intracranial disease,
• Tracheostomy.
• Severe intensive care unit (ICU) acquired neuromyopathy, with primary unilateral/bilateral absence of diaphragmatic mobility,
• Patients who had previously failed spontaneous breathing trial (SBT).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Success rate of extubation	48 hours post-extubation	Success rate of extubation was recorded

Secondary Outcome Measures

Name	Time	Method
Diaphragmatic Thickening Fraction (DTF)	Within 1 hour prior to extubation	Assessment of diaphragmatic Thickening Fraction (DTF) as a predictor of weaning success, measured using ultrasound.
Diaphragmatic Excursion (DE)	Within 1 hour prior to extubation	Assessment of diaphragmatic excursion as a predictor of weaning success, measured using ultrasound.
Lung Ultrasound Score (LUS)	Within 1 hour prior to extubation	Evaluation of lung Ultrasound Score (LUS) as a predictor of extubation outcome, measured before extubation using standard lung ultrasound protocols.

Trial Locations

Locations (1)

Kafrelsheikh University; 🇪🇬 Kafr Ash Shaykh, Kafr Elsheikh Governorate, Egypt