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Not yet recruiting NCT07082361

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

No phase Interventional Ultrasonography Mechanical Ventilation Weaning Chronic Obstructive Pulmonary Disease (COPD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: conventional clinical criteria of weaning from mechanical ventilation, conventional clinical criteria and ultrasonic criteria for weaning.
Who it may be relevant to
Registry conditions: Ultrasonography, Mechanical Ventilation Weaning, Chronic Obstructive Pulmonary Disease (COPD). Basic parameters: 21 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Primary outcome measures

  • Number of patients with failed weaning trial [Time frame: 28 day]
Secondary outcome measures (2)
  • Time till extubation trial. [Time frame: 28 days]
  • Number of Intensive care unit discharges [Time frame: 28 days]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Egypt · 1 center
  • Tanta University — Tanta

Identifiers

NCT: NCT07082361 · 36264MS719/10/24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗