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Randomized trial in AECOPD patients to compare efficacy of iVAPS and ST mode of NIV in prevention of post extubation respiratory failure

To compare efficacy of iVAPS versus S/T Mode as Non-invasive Weaning Strategy in post extubation COPD Patients for prevention of post extubation respiratory failure: A Pilot Randomized Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/048506
Enrollment
100
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: iVAPS mode: Based on patientâ??s height targeted alveolar ventilation will be adjusted with a Tidal Volume of 8 ml/kg of ideal body weight. Expiratory Positive Airway Pressure (EPAP) w
Minimum and maximum Pressure Support (PS) will be 8-20 cm of H20 will be set and adjusted as per the need of the patient. Day 0 NIV application will be continuous and duration of 16-18 hours, On day

Sponsors

AIIMS Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Indication for NIV post extubation (any one of the following high-risk criteria): 1.Underlying chronic obstructive airway disease (COAD) with paco2 >45 mm Hg at extubation 2.Age >65 years 3.History of chronic heart failure (New York Heart Association class II-IV) or left ventricular ejection fraction 4.Prior failed spontaneous breathing trial 5.Two or more organ system failure other than chronic respiratory or heart failure. Inclusion criteria: 1.Acute exacerbation of COPD patient requiring Invasive Mechanical Ventilation (IMV) for at least 24 hours. 2.Patient on IMV fulfilling extubation criteria and passing spontaneous breathing trial. 3.Patient on IMV planned to put on NIV support post extubation for any one of the above mentioned high risk criteria.

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.Patient not giving consent to participate in the study

Design outcomes

Primary

MeasureTime frame
1.Success rate of either mode: Success will be considered when the patient is able to achieve the following: pH 7.35, decrease in partial pressure of carbon dioxide (PaCO2) of 15-20%, partial pressure of oxygen (PaO2) 60 mmHg, arterial oxygen saturation (SaO2) 90% on fraction of inspired oxygen (FiO2) 40%, RR 24 bpm and no signs of respiratory distress like agitation, diaphoresis or anxiety.Timepoint: 72 hours post extubation

Secondary

MeasureTime frame
Degree of patients comfortTimepoint: Twice a day till on NIV support;Duration spent on NIVTimepoint: Till discharge from ICU;Length of ICU stayTimepoint: Till discharge from ICU;Re-intubation rate in each groupTimepoint: 72 hours from extubation

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