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

Phase 4

Conditions: Health Condition 1: J960- Acute respiratory failure

Registration Number: CTRI/2019/07/019993

Lead Sponsor: VMMC and Safdarjung Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

1.Presence of hypotension (defined as mean arterial BP of <65mmHg), tachycardia (defined as a heart rate 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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