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MDI and Spacer vs Nebuliser in Intubated patients in ICU (MS/Neb-In ICU study)

A randomized controlled study comparing bronchodilator administered using a Metered Dose Inhaler with inline spacer vs inline nebulisation in intubated patients in the ICU - MS/Neb-In ICU study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/07/019993
Enrollment
26
Registered
2019-07-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: J960- Acute respiratory failure

Interventions

Intervention1: Metered dose inhaler (MDI) with Spacer: Levosalbutamol sulphate and ipratropium bromide delivered by MDI will be given as four puffs (100 mcg Levosalbutamol/ 20 mcg ipratropium per inha

Sponsors

VMMC and Safdarjung Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Ventilator-dependent patients, in whom the treating physician has ordered bronchodilator aerosols for suspected airways obstruction 2. Age more than 18 years 3. Informed consent available from the legally authorized representative (LAR)

Exclusion criteria

Exclusion criteria: 1. Presence of hypotension (defined as mean arterial BP of 100/min), and/or hemodynamically significant cardiac arrhythmias. 2. A history of symptomatic coronary artery disease in the 6 months prior to admission 3. Patients who have received a short acting bronchodilator in the last 6 hours or a long acting bronchodilator in the last 24 hours 4. Pregnant patients

Design outcomes

Primary

MeasureTime frame
a) Respiratory System Resistance (RRS) b) Peak Expiratory Resistance (RPEAK) c) Peak Pressure (Ppeak) d) Mean Pressure (Pmean) e) Plateau Pressure (Pplat) f) Compliance Dynamic g) Compliance Static h) Delta Airway Pressure (dPAW) i) Peak Inspiratory Flow Rate (PIFR) j) Peak Expiratory Flow Rate (PEFR) k) Ventilator Work of Breathing (WOBV) l) The intrinsicPEEP / autoPEEPAWTimepoint: The measurements will be done at baseline and then at 30 minutes, 60 minutes and 6 hours.

Secondary

MeasureTime frame
Additional nebulisation delivered in the 6 hours following administration of levosalbutamol sulphate and ipratropium bromideTimepoint: At the end of 6 hours;Any arrhythmia which requires a change in the treatment of the patientTimepoint: At the end of 6 hours;The arterial blood gas and the serum potassiumTimepoint: The arterial blood gas will be repeated after 6 hours. The serum potassium values will be documented in the following 24 hours after the administration of the bronchodilator.;The Heart rate, BP and the SpO2Timepoint: Will be documented at baseline, 30 minutes, one hour and six hours after the administration.;Time taken to administer the bronchodilator drug (in minutes)Timepoint: At the end of 6 hours

Countries

India

Contacts

Public ContactDr Rohit Kumar

Vardhman Mahavir Medical College and Safdarjung Hospital (VMMC&SJH)

dr.rohitkumar@mail.com09911218081

Outcome results

None listed

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