The Use of Diaphragmatic Ultrasonography in Mechanical Ventilation Weaning Decision in COPD Patient

NCT07082361 | Not Yet Recruiting

• 1 other identifier: 36264MS719/10/24
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the use of diaphragmatic ultrasonography in taking mechanical ventilation weaning decision and predicting outcome in Chronic obstructive pulmonary disease patient. Primary outcome:

• Number of patients with failed weaning trial and need reintubation. Secondary outcomes:
• Time till extubation trial.
• Ventilation free days after extubation less or more than 48h .
• Number of Intensive care unit discharges.
• Sensitivity and specificity of diaphragmatic assessment as a predictor of weaning.

Conditions

Ultrasonography; Mechanical Ventilation Weaning; Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Ultrasonography; Diaphragmatic; Mechanical Ventilation; Weaning

Outcome Measures

Primary Outcomes (1)

• Number of patients with failed weaning trial

  28 day

Secondary Outcomes (2)

• Time till extubation trial.

  28 days

• Number of Intensive care unit discharges

  28 days

Study Arms (2)

conventional clinical criteria of weaning from mechanical ventilation by using spontaneous breathing

EXPERIMENTAL

Patients will be weaned after fulfilling the conventional clinical criteria of weaning from mechanical ventilation by using spontaneous breathing trials

Diagnostic Test: conventional clinical criteria and ultrasonic criteria for weaning

conventional clinical criteria and ultrasonic criteria for weaning

EXPERIMENTAL

Patients will be weaned using the conventional clinical criteria and ultrasonic criteria for weaning.

Diagnostic Test: conventional clinical criteria of weaning from mechanical ventilation

Interventions

conventional clinical criteria of weaning from mechanical ventilation DIAGNOSTIC_TEST

Patients will be weaned after fulfilling the conventional clinical criteria of weaning from mechanical ventilation by using spontaneous breathing trials

conventional clinical criteria and ultrasonic criteria for weaning

conventional clinical criteria and ultrasonic criteria for weaning DIAGNOSTIC_TEST

Patients will be weaned using the conventional clinical criteria and ultrasonic criteria for weaning.

conventional clinical criteria of weaning from mechanical ventilation by using spontaneous breathing

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient more than 21 years old of both sexes, coming to our intensive care unit with acute exacerbation of Chronic obstructive pulmonary disease \& need mechanical ventilation at least 48 hr.

You may not qualify if:

• Patient refusal.
• Morbid obesity with body mass index \> 35 kg/m2.
• Patients with a history of recent thoracic surgery.
• Neuromuscular disorders affecting the diaphragm e.g.(myopathy).
• Congenital diaphragmatic disorders (Hiatal hernia).

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Gharbia Governorate, Egypt

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Weaning

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Infant Nutritional Physiological Phenomena; Child Nutritional Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Shimaa Badr, Resident

CONTACT

+20 10 93734644; ahmed.mostafa.hassan2023@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 24, 2025
• Study Start: October 30, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 24, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)