Status:

COMPLETED

PSV Versus ASV With Intellisync Mode for Delivery of NIV in AECOPD

Lead Sponsor:

Post Graduate Institute of Medical Education and Research, Chandigarh

Conditions:

COPD Exacerbation Acute

COPD Exacerbation

Eligibility:

All Genders

13+ years

Phase:

NA

Brief Summary

Acute exacerbation of chronic obstructive pulmonary disease (COPD) is defined acute worsening of respiratory symptoms requiring additional therapy. COPD exacerbations affects the health status and qua...

Detailed Description

Acute exacerbation of chronic obstructive pulmonary disease are periods of acute worsening during the course of illness which increase hospital admission and mortality. Intensive care unit admission a...

Eligibility Criteria

Inclusion

  • Consecutive subjects with AECOPD will be eligible for inclusion in the study if they meet all the following:
  • an acute (\<7 days) sustained worsening of any of the patient's respiratory symptoms (cough, sputum quantity or character, dyspnea) beyond the normal day-to-day variation;
  • arterial blood gas analysis showing a PaCO2 \>45 mm Hg with either pH between 7.25 and 7.35 or respiratory rate (18) \>30 breaths/minute; and,
  • exclusion of other causes of acute breathlessness such as acute heart failure, pulmonary embolism, pneumonia, and pneumothorax.

Exclusion

  • Patients with any one of the following criteria will be excluded from the current study:
  • Non-COPD acute hyper-capneic respiratory failure.
  • Hypotension (systolic blood pressure \<90 mmHg).
  • Severe impairment of consciousness (Glasgow coma scale score \<8).
  • Inability to clear respiratory secretions.
  • Abnormalities that preclude proper fit of the NIV interface (agitated or uncooperative patient, facial trauma or burns, facial surgery, or facial anatomical abnormality).
  • Subjects who have an artificial airway like tracheostomy tube or T-tube.
  • Patient already on home NIV therapy for chronic respiratory failure.
  • Failure to provide informed consent.

Key Trial Info

Start Date :

December 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 30 2025

Estimated Enrollment :

55 Patients enrolled

Trial Details

Trial ID

NCT06160687

Start Date

December 1 2023

End Date

April 30 2025

Last Update

July 23 2025

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Respiratory ICU, Department of Pulmonary Medicine, PGIMER

Chandigarh, Chandigarh, India, 160012