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Completed

NCT Number: NCT07057804

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kafrelsheikh University

Kafr ash Shaykh, Kafr Elsheikh Governorate, 33516, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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).

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.

Primary outcomes

  1. Success rate of extubation

    Time frame: 48 hours post-extubation

    Success rate of extubation was recorded

Secondary outcomes

  1. Diaphragmatic Excursion (DE)

    Time frame: Within 1 hour prior to extubation

    Assessment of diaphragmatic excursion as a predictor of weaning success, measured using ultrasound.

  2. Diaphragmatic Thickening Fraction (DTF)

    Time frame: Within 1 hour prior to extubation

    Assessment of diaphragmatic Thickening Fraction (DTF) as a predictor of weaning success, measured using ultrasound.

  3. Lung Ultrasound Score (LUS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 10, 2025
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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