| CTRI Number |
CTRI/2025/06/088878 [Registered on: 16/06/2025] Trial Registered Prospectively |
| Last Modified On: |
14/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARING THE INCIDENCE OF VENTILATOR ASSOCIATED PNEUMONIA IN MECHANICALLY VENTILATED PATIENTS BY USING THREE DIFFERENT TECHNIQUES OF BRNCHODILATION: A PROSPECTIVE OPEN LABELLED RANDOMISED CONTROL STUDY
|
|
Scientific Title of Study
|
COMPARING THE INCIDENCE OF VENTILATOR ASSOCIATED PNEUMONIA IN MECHANICALLY VENTILATED PATIENTS BY USING THREE DIFFERENT TECHNIQUES OF BRNCHODILATION: A PROSPECTIVE OPEN LABELLED RANDOMISED CONTROL STUDY
|
| Trial Acronym |
Prospective open labelled randomised controlled study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SOURAV DEY |
| Designation |
DM TRAINEE CRITICAL CARE MEDICINE |
| Affiliation |
AIIMS Jodhpur |
| Address |
A/904,Mangaldeep Apartment
Pal Road,Jodhpur
Rajasthan
Pin Code:342008
Jodhpur
RAJASTHAN
342008
India |
| Phone |
07001105639 |
| Fax |
|
| Email |
iamfrodo48@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SOURAV DEY |
| Designation |
DM TRAINEE CRITICAL CARE MEDICINE |
| Affiliation |
AIIMS Jodhpur |
| Address |
A/904,Mangaldeep Apartment
Pal Road,Jodhpur
Rajasthan
Pin Code:342008
Jodhpur
RAJASTHAN
342008
India |
| Phone |
07001105639 |
| Fax |
|
| Email |
iamfrodo48@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SOURAV DEY |
| Designation |
DM TRAINEE CRITICAL CARE MEDICINE |
| Affiliation |
AIIMS Jodhpur |
| Address |
A/904,Mangaldeep Apartment
Pal Road,Jodhpur
Rajasthan
Pin Code:342008
Jodhpur
RAJASTHAN
342008
India |
| Phone |
07001105639 |
| Fax |
|
| Email |
iamfrodo48@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR- INSTITUTIONAL FUND. |
|
|
Primary Sponsor
|
| Name |
AIIMS Jodhpur |
| Address |
Marudhar Industrial Area,Basni
Jodhpur.Rajasthan
Pin Code 342005 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SOURAV DEY |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR |
Adult Intensive Care Unit
Marudhar Industrial area,
Basni,Jodhpur
Rajasthan
Pin 342005
Jodhpur
RAJASTHAN |
07001105639
iamfrodo48@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS JODHPUR Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J398||Other specified diseases of upperrespiratory tract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bronchodilatation using three different techniques in mechanically ventilated patients |
Three different types of intervention for broncho dilatation in patients with mechanical ventilation. |
| Comparator Agent |
Three techniques for broncho dilatation. |
1. Inhalational bronchodilator will be given through nebulisation.
2.Inhalational bronchodilator will be given through metered dose inhaler.
3. Intravenous agent with bronchodilatation property will be given. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients in ICU requiring mechanical ventilatory support |
|
| ExclusionCriteria |
| Details |
Patients already developed VAP at the time of evaluation for inclusion in the study.
Immuno-compromised patients (HIV, HBsAg positive, Leukemia, On immune suppressants).
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of ventilator associated pneumonia (VAP) in patients with mechanical ventilation when three different techniques of bronchodilatation are used. |
VAP incidence during their stay in adult intensive care unit. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Level of TNF alfa in bronchoalveolar lavage fluid (BAL) in all the patients.
Level of CRP (C reactive protein) in blood in all the patients.
Number of days bronchodilator ( i.e. nebulization/MDI/Intravenous drugs) administration required
Number of ventilator free days.
Length of ICU stay
All-cause mortality at 28 days
|
During their stay in adult intensive care unit. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
COMPARING THE INCIDENCE OF VENTILATOR ASSOCIATED PNEUMONIA IN MECHANICALLY VENTILATED PATIENTS BY USING THREE DIFFERENT TECHNIQUES OF BRNCHODILATION: A PROSPECTIVE OPEN LABELLED RANDOMISED CONTROL STUDY This study is to check whether there is any difference in incidence of VAP in patients using three different ways of brocho-dilatation. |