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NCT Number: NCT07082361

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

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.

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Key information

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

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

Diagnostic Test

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

Primary outcomes

  1. Number of patients with failed weaning trial

    Time frame: 28 day

Secondary outcomes

  1. Time till extubation trial.

    Time frame: 28 days

  2. Number of Intensive care unit discharges

    Time frame: 28 days

Study contacts

Contact information is provided by the study sponsor or research team.

Shimaa Badr, Resident

CONTACT

[email protected]

+20 10 93734644

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

The Use of Diaphragmatic Ultrasonography: Does It Change Mechanical Ventilation Weaning Decision and Predict Outcome in COPD Patient?

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 24, 2025
Registry last updated
Jul 24, 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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