To compare between two groups of patients suffering from chronic lung disease who fails to maintain breathing on artificial machine through mask , the two groups includes one who receives oral tablets and the other who receives injections

Comparing non-invasive ventilation failure with oral versus intravenous systemic steroids in the treatment of moderate to severe exacerbation of chronic obstructive pulmonary disease patients in the respiratory intensive care unit: Pilot study - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/069844

Enrollment

Registered

2024-07-03

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

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: Inj. Hydrocortisone: Inj. Hydrocortisone 100mg BD after food for 5 days followed by 60 mg BD after food for 5 days. Total duration -10 days Control Intervention1: Oral prednisolone: Ta

Eligibility

Inclusion criteria

Inclusion criteria: ï?? COPD in moderate to severe acute exacerbation requiring NIV admitted in RICU ï?? Age more than 40 years ï?? Informed Consent for study

Exclusion criteria

Exclusion criteria: Contraindications of NIV: 1. Unable to tolerate NIV reduced consciousness and inability to protect the airways 2. Uncooperative patient 3. Copious respiratory secretions 4. Nausea with vomiting 5. Facial trauma burns 6. Shock patients requiring inotropes Contraindications of steroids: 1. H/o git bleed in the past 1 month Others: 1. Chronic kidney injury 2. Left heart failure 3. Cor pulmonale in failure 4. liver failure 5. pneumonia 6. pneumothorax requiring intervention 7. pregnancy 8. lactating mother

Design outcomes

Primary

Measure	Time frame
To compare the NIV failure between oral steroids and IV steroids as an occurrence in any of the following events, subjects requiring Endotracheal intubation The reinstitution of NIV within 48 hours of initial discontinuation of NIV Any Hospital DeathTimepoint: 4 weeks	—

Secondary

Measure	Time frame
To compare the following variables between oral steroids and IV steroids Duration of ventilation NIV and mechanical combined Length of hospital stay Readmission of acute exacerbation of COPD within 28 days Quality of life assessment by clinical COPD respiratory questionnaire and St George respiratory questionnaire at discharge and 28 day follow up Adverse effects of systemic steroids such as hyperglycemia, started on insulin therapy, gastrointestinal bleeding, and hospital acquired infectionsTimepoint: 28days	—

Measure

Time frame

To compare the following variables between oral steroids and IV steroids Duration of ventilation NIV and mechanical combined Length of hospital stay Readmission of acute exacerbation of COPD within 28 days Quality of life assessment by clinical COPD respiratory questionnaire and St George respiratory questionnaire at discharge and 28 day follow up Adverse effects of systemic steroids such as hyperglycemia, started on insulin therapy, gastrointestinal bleeding, and hospital acquired infectionsTimepoint: 28days

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Countries

India

Contacts

Public ContactDr KaminiM

Jawarhalal Institute of Postgraduate Medical Education and Research, Puducherry

kaminimariyappan@gmail.com8220181658

Outcome results

None listed

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