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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06143150
Collaborator
(none)
155
49

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: transthoracic ultrasound

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 Design

Study Type:
Observational
Anticipated Enrollment :
155 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Can Transthoracic Ultrasound Assessment of the Diaphragmatic Performance Predict the Outcome of Non Invasive Ventilation in Critically Ill COPD Patients With Acute Exacerbation
Anticipated Study Start Date :
Nov 15, 2023
Anticipated Primary Completion Date :
Nov 15, 2026
Anticipated Study Completion Date :
Dec 15, 2027

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Time saving [Baseline]

    To estimate: In hospital mortality. Length of ICU stay. Length of hospital stay.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Mona Adel, Doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT06143150
Other Study ID Numbers:
  • Diaphragmatic performance
First Posted:
Nov 22, 2023
Last Update Posted:
Nov 22, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 22, 2023