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Comparison of the effects of ipratropium/salbutamol drugs combination with another drug, called glycopyrronium, all given by nebulization, in patients suffering from the disease called, chronic obstructive pulmonary disease, and are now very sick and on ventilator.

COMPARISON OF NEBULIZED GLYCOPYRRONIUM WITH COMBINATION OF SALBUTAMOL AND IPRATROPIUM ON VENTILATORY PARAMETERS IN CRITICALLY ILL PATIENTS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/11/047216
Enrollment
60
Registered
2022-11-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: J440- Chronic obstructive pulmonary disease with acute lower respiratory infection

Interventions

Intervention1: Glycopyrronium respule for nebulization: 2ml of Glycopyrronium (25mcg/ml)will be nebulized two times daily through the inbuilt vibrating mesh nebulizer of the mechanical ventilator for

Sponsors

Dr Ram Manohar Lohia Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Those patients whose next of kin consents to participation in the study 2. Age >18 years, 3. Known case of COPD who were intubated and mechanically ventilated.

Exclusion criteria

Exclusion criteria: 1. Patient’s kin’s refusal to give consent 2. Patient with heart diseases like coronary artery disease-confirmed or suspected, and valvular disease 3. Patients with tachyarrhythmia 4. Those patients who had pre-existing thick or inspissated sputum. 5. Patients on any heart rate controlling drug, like beta blockers, calcium channel blockers, amiodarone or ivabradine. 6. Patients with a diagnosis of pneumonia, pulmonary oedema, refractory hypoxaemia, pneumothorax, haemodynamic instability. 7. Patients who have known sensitivity to Glycopyrrolate, salbutamol or ipratropium.

Design outcomes

Primary

MeasureTime frame
Effectiveness in causing bronchodilation is by the End-inspiratory static compliance (Cstat), minimum (Rint) and maximum (Rrs) resistance of the respiratory system.and duration by the time the Rint remains less than 85% of baseline value. Timepoint: Data will be collected at 15, 30, 60 minutes as well as at 2, 3, 4, 6, 8, 10 and 12 hours after each nebulisation.—

Secondary

MeasureTime frame
To examine the incidence of any side effect attributable to nebulized, long acting muscarinic antagonist, glycopyrronium in critically ill mechanically ventilated patients of COPD.Timepoint: Data will be collected at 15, 30, 60 minutes as well as at 2, 3, 4, 6, 8, 10 and 12 hours after each nebulisation.—

Countries

India

Contacts

Public ContactDR Preeti Priya

Dr Ram MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES

preetipriya06@gmail.com9163426296

Outcome results

None listed

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