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

NCT ID: NCT07082361

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-30
• Study Completion Date: 2025-12-30

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.

Detailed Description

Chronic obstructive pulmonary disease is the fourth killer among all diseases worldwide. It can be prevented and treated, so it is an important public health challenge. Inspiratory muscle weakness has a great clinical association with Chronic obstructive pulmonary disease patients. The prolonged mechanical ventilation and weaning failure may be related to diaphragmatic muscle dysfunction. The traditional weaning parameters (e.g., spontaneous tidal volume ), Maximum inspiratory pressure , and rapid shallow breathing index are considered useful parameters for weaning. Although, they have unsatisfactory prediction rates.

Exacerbation of Chronic obstructive pulmonary disease is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management .

In most patients, mechanical ventilation can be discontinued as soon as the underlying reason for acute respiratory failure has been resolved. However, Patients spend receiving mechanical ventilation is devoted to weaning and increase up to, 59% in Chronic obstructive pulmonary disease patients .

There are innumerable factors responsible for the failure of weaning from mechanical ventilation. Factors that should be considered in all patients include misadjusted ventilator settings, infections, airway patency and respiratory muscle performance. Malnutrition, which is common in ventilator dependent patients, has detrimental effects on the respiratory system. Heart failure or coronary ischemia can be induced by the reduction of ventilatory support which causes weaning failure. A number of electrolyte imbalances and psychological problems can be an impediment to successful weaning.

Diaphragmatic ultrasound is non-invasive, radiation-free, widely available, provides immediate and accurate results, and can be repeated at the bedside . Diaphragm sonography values provide useful information for assessing and monitoring mechanically ventilated patients .

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.

A randomized controlled study will be carried out on patients admitted to Anesthesia & Surgical intensive care unit Department in Tanta University Hospitals over a period of 1 year

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

conventional clinical criteria and ultrasonic criteria for weaning

Intervention Type: DIAGNOSTIC_TEST

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

conventional clinical criteria and ultrasonic criteria for weaning

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

Group Type: EXPERIMENTAL

conventional clinical criteria of weaning from mechanical ventilation

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

conventional clinical criteria of weaning from mechanical ventilation

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

Intervention Type: DIAGNOSTIC_TEST

conventional clinical criteria and ultrasonic criteria for weaning

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Shimaa Adel Mohamed Helmy Badr

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, Gharbia Governorate, Egypt

Countries

Egypt

Central Contacts

Shimaa Badr, Resident

Role: CONTACT

ahmed.mostafa.hassan2023@gmail.com

+20 10 93734644

Facility Contacts

Shimaa Badr, Resident

Role: primary

aliaamohamedali@gmail.com

01099531489

Other Identifiers

36264MS719/10/24

Identifier Type: -

Identifier Source: org_study_id