Prediction of Outcome of Non Invasive Ventilation COPD Patients by Assessment of Diaphragmatic Performance

Not yet recruiting

• Conditions: Acute Exacerbation COPD

• Registration Number: NCT06143150
• Lead Sponsor: Assiut University

Brief Summary

Transthoracic ultrasonographic assessment of the diaphragmatic performance as a predictor for the outcome of NIV in critically ill COPD patients with acute exacerbation.

Detailed Description

Chronic obstructive pulmonary disease (COPD) is considered a common disease worldwide, and it poses a major health and economic problem.

COPD was the fifth leading cause for death in 2022 and will rank third by 2030. So, it's considered a devastating disease for patients and their loved ones .

Patients presented with acute exacerbations of COPD may need respiratory intensive care unit (RICU) admission. Non invasive ventilation (NIV) is considered a cornerstone management option in patients with acute exacerbation of COPD (AECOPD). Therefore, early prediction of NIV failure may help in decision making regarding escalation to invasive mechanical ventilation To date, the diaphragm is the main respiratory muscle, and derangement of it's function is an important factor in the pathophysiology of COPD COPD patients have increased airway resistance and airflow limitation, which in turn increases the mechanical load of breathing exerted on the diaphragm Diaphragmatic weakness in COPD patients results from decreased muscle strength and mobility . Although, diaphragmatic performance is a key determinant of dyspnea in COPD patients, it is rarely assessed in clinical practice In practice, only vital sign such as respiratory rate and arterial blood gases parameters (ABG) such as PH, PaO2, PaCO2, SPO2, and fiO2/paO2 are considered predictors of NIV outcome.

Assessment of diaphragmatic function transthoracic ultrasound (TUS) is a reliable, safe and bed side method for prediction of NIV outcome . Several tools commonly applied to determine diaphragmatic function such as; fluoroscopy, Computed tomography (CT), transdiaphragmatic pressure measurement, phrenic nerve stimulation, and electromyography can't be routinely used in intensive care units due to technical challenges and limitations

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-07
• Study Start: 2023-11-15
• Study First Submitted QC: 2023-11-20
• Last Update Submitted: 2023-11-20
• Study First Posted: 2023-11-22
• Last Update Posted: 2023-11-22
• Primary Completion: 2026-11-15
• Study Completion: 2027-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

• One Hundred fifty five critically ill COPD patients admitted to respiratory intensive care unit
• Diagnosis of COPD and COPD exacerbation is fulfilled according to GOLD 2022 criteria
• Age>40years

Exclusion Criteria

• Age ˂ 40 years.
• Refusal to participate in the study.
• Patients with morbid obesity (BMI>40).
• Absolute indication for intubation like coma ,hemodynamic instability, or life threatening arrhythmia.
• Contraindication to NIV like untreated pneumothorax, pneumothorax with air leak, widespread facial burn or trauma, tracheotomy, or active upper gastrointestinal bleeding.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ultrasonographic assessement of COPD patients	Baseline	To assess the diaphragmatic performance by transthoracic ultrasound in critically ill COPD patients with acute exacerbation

Secondary Outcome Measures

Name	Time	Method
Time saving	Baseline	To estimate: * In hospital mortality.; * Length of ICU stay.; * Length of hospital stay.