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

November 20, 2023 updated by: Mona Adel, Assiut University

Can Transthoracic Ultrasound Assessment of the Diaphragmatic Performance Predict the Outcome of Non Invasive Ventilation in Critically Ill COPD Patients With Acute Exacerbation

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

155

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

COPD patients admitted to respiratory intensive care unit with acute exacerbation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ultrasonographic assessement of COPD patients
Time Frame: Baseline
To assess the diaphragmatic performance by transthoracic ultrasound in critically ill COPD patients with acute exacerbation
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time saving
Time Frame: Baseline

To estimate:

  • In hospital mortality.
  • Length of ICU stay.
  • Length of hospital stay.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 15, 2023

Primary Completion (Estimated)

November 15, 2026

Study Completion (Estimated)

December 15, 2027

Study Registration Dates

First Submitted

November 7, 2023

First Submitted That Met QC Criteria

November 20, 2023

First Posted (Estimated)

November 22, 2023

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Diaphragmatic performance

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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