Status:
COMPLETED
Non Invasive Ventilation With NAVA vs ASV for AECOPD
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Acute Exacerbation of COPD
Eligibility:
All Genders
Phase:
NA
Brief Summary
Non invasive ventilation is the standard of care in managing patients with exacerbation of chronic obstructive pulmonary disease. However no optimal mode of NIV delivery is established; failure rates ...
Detailed Description
Study hypothesis We hypothesize that NIV-NAVA would be superior to ASV in reducing the NIV failure rates in patients with AECOPD. In this study, we plan to compare the ASV with NAVA during NIV in pati...
Eligibility Criteria
Inclusion
- Consecutive subjects with AECOPD will be eligible for inclusion in the study if they meet all the following: (a) 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; (b) arterial blood gas analysis showing a PaCO2 \>45 mm Hg with either pH between 7.10 and 7.35 or respiratory rate (fR) \>30 breaths/minute; and, (c) 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
- Contraindications for insertion of naso-/orogastric feeding tube (facial/nasal trauma, recent upper airway surgery, esophageal surgery, esophageal varices, upper gastrointestinal bleeding)
- Unwillingness to undergo placement of nasogastric catheter
- Known phrenic nerve lesions
- Suspected diaphragmatic weakness
- Patient already on home NIV therapy for chronic respiratory failure
- Failure to provide informed consent
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT04414891
Start Date
December 1 2019
End Date
December 31 2020
Last Update
August 9 2021
Active Locations (1)
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1
Respiratory Intensive Care Unit, PGIMER
Chandigarh, India, 160012