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Randomized trial on AECOPD patients to assess efficacy of three strategies of NIV withdrawal in prevention of post extubation respiratory failure

Comparison of three strategies for withdrawal of post-extubation Non-Invasive Ventilation in patients of Acute Exacerbation of COPD with Acute Hypercapnic Respiratory Failure undergoing Invasive Mechanical Ventilation: Randomized Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/048501
Enrollment
84
Registered
2022-12-26
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J441- Chronic obstructive pulmonary disease with (acute) exacerbation

Interventions

Intervention1: Immediate withdrawal of NIV : Immediate withdrawal of NIV. Duration and frequency Nil Intervention2: Stepwise reduction of pressure support : Stepwise reduction of pressure support: pre

Sponsors

AIIMS Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Acute exacerbation COPD patients requiring Invasive Mechanical Ventilation (IMV). 2.Planned extubation following invasive ventilation for at least 24 hours and planned to put on NIV support post extubation for any one of the above mentioned high-risk criteria 3.Acute exacerbation COPD patients on IMV fulfilling extubation criteria and passing Spontaneous breathing trial.

Exclusion criteria

Exclusion criteria: 1.Other chest diseases (ILD, bronchiectasis, Concomitant malignancy). 2.Contraindications to NIV application (example: craniofacial trauma or surgery, ongoing upper gastrointestinal bleeding, excessive respiratory secretions or inability to handle secretion, recurrent vomiting, tracheotomised, etc.) 3.Participant denied giving a written informed consent

Design outcomes

Primary

MeasureTime frame
1.Successful withdrawal of NIV among the three groupsTimepoint: 1. 48 hours of NIV withdrawal—

Secondary

MeasureTime frame
1.Time to recurrence of HcRF (from the time of randomization) 2.Total number of hours of NIV use 3.Length of hospital stay 4.Inâ??hospital mortalityTimepoint: 1. Time of randomization to 48 hours post withdrawal of NIV 2. Time of randomization to 48 hours post withdrawal of NIV 3.Time of randomization to discharge from hospital 4. Time of randomization to death in hospital—

Countries

India

Contacts

Public ContactPrakhar Sharma

AIIMS Rishikesh

drprakhar2009@gmail.com8979616104

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026