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To compare the result of inhaler vs nebulisation therapy while using NIV in acute exacerbation of COPD.

To compare the serum level of Ipratropium Bromide delivered through pMDI versus nebulization during NIV therapy in acute exacerbation of COPD cases.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/054734
Enrollment
40
Registered
2023-07-04
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

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: Ipratropium Bromide delivery via pMDI through Easy2Neb mask during NIV therapy.: Ipratropium Bromide (20mcg) via pMDI, 2 puffs 6 hourly for first 24 hours while on NIV therapy. Control

Sponsors

Pt. B. D. Sharma PGIMS Rohtak
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged >40 years. 2. Clinically suspected patients in AECOPD. 3. Patients of COPD in type 2 respiratory failure and pH between 7.25-7.35.

Exclusion criteria

Exclusion criteria: 1. Any obstructive or restrictive respiratory disease other than COPD. 2. Hemodynamically unstable, defined as systolic blood pressure 3. Patients in need of emergency intubation. 4. Arterial pH 5. Patients in altered sensorium or Glasgow Coma Scale (GCS) less than 12. 6. Patients with facial deformity, trauma or surgery where proper oronasal mask seal cannot be ensured. 7. Patients with hypersensitivity to Levosalbutamol, coronary artery disease (CAD), tachyarrhythmias, and diabetic ketoacidosis (DKA).

Design outcomes

Primary

MeasureTime frame
To measure the level of Ipratropium Bromide in blood post aerosol therapy using pMDI versus jet nebulizer via face mask during NIV therapy.Timepoint: 30 minutes, 1 hour & 6 hours after aerosol therapy (prior to the next dose) in both arms.

Secondary

MeasureTime frame
pH, pO2 & pCO2 will be measuredTimepoint: Before & after 2 hours of aerosol therapy in both arms.;Respiratory rate (RR), heart rate (HR) & oxygen saturation by pulse oximeter (SpO2) will be measuredTimepoint: 30 minutes, 1 hour & 6 hours after aerosol therapy (prior to the next dose) in both arms.

Countries

India

Contacts

Public ContactVishal Raj

Pt. B. D. Sharma PGIMS Rohtak

vishalraj.raj5@gmail.com7992476491

Outcome results

None listed

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