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

NCT07057804 | Completed

• 1 other identifier: KFSIRB200-202
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung; Diaphragm; Ultrasound; Extubation; Weaning; Mechanically Ventilation; Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• Success rate of extubation

  Success rate of extubation was recorded

  48 hours post-extubation

Secondary Outcomes (3)

• Diaphragmatic Excursion (DE)

  Within 1 hour prior to extubation

• Diaphragmatic Thickening Fraction (DTF)

  Within 1 hour prior to extubation

• Lung Ultrasound Score (LUS)

  Within 1 hour prior to extubation

Study Arms (1)

Study group

Patients who met the standard clinical weaning criteria underwent bedside lung and diaphragm ultrasound at the end of a successful spontaneous breathing trial (SBT).

Diagnostic Test: Lung Ultrasound; Diagnostic Test: Diaphragm Ultrasound

Interventions

Lung Ultrasound DIAGNOSTIC_TEST

Ultrasound was performed at the bedside with the patient in a semi-recumbent position using a 3.5-5 MHz curvilinear probe. Lung ultrasound was conducted across 12 zones (anterior and posterior) to evaluate aeration and calculate the lung ultrasound score (LUS).

Study group

Diaphragm Ultrasound DIAGNOSTIC_TEST

Ultrasound was performed at the bedside with the patient in a semi-recumbent position using a 3.5-5 MHz curvilinear probe. Diaphragmatic excursion and thickening fraction were measured on the right hemidiaphragm.

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study trial was carried out on 90 patients required invasive mechanical ventilation for a minimum of 24 hours and weaning criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafr Elsheikh Governorate, 33516, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine, Kafr Elsheikh University, Kafr Elsheikh, Egypt.

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 10, 2025
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)