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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07082361
Enrollment
140
Registered
2025-07-24
Start date
2025-10-30
Completion date
2025-12-30
Last updated
2025-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Ultrasonography, Diaphragmatic, Mechanical Ventilation, Weaning

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

Interventions

DIAGNOSTIC_TESTconventional 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

DIAGNOSTIC_TESTconventional clinical criteria and ultrasonic criteria for weaning

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

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
Number of patients with failed weaning trial28 day

Secondary

MeasureTime frame
Time till extubation trial.28 days
Number of Intensive care unit discharges28 days

Countries

Egypt

Contacts

Primary ContactShimaa Badr, Resident
ahmed.mostafa.hassan2023@gmail.com+20 10 93734644

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026