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)
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1
Respiratory ICU, Department of Pulmonary Medicine, PGIMER
Chandigarh, Chandigarh, India, 160012