| CTRI Number |
CTRI/2024/03/064418 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation of the incidence of ventilator associated pneumonia in continuous versus intermittent subglottic suctioning groups intubated patients in intensive care unit |
|
Scientific Title of Study
|
Comparative evaluation of the incidence of ventilator associated pneumonia in continuous vs. intermittent subglottic suctioning in intensive care unit |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankit Sinha |
| Designation |
Senior Resident |
| Affiliation |
AHRR, DELHI |
| Address |
MAIN ICU, 2ND FLOOR, ARMY HOSPITAL RESEARCH AND REFERRAL,DELHI
South
DELHI
110029
India |
| Phone |
9811329969 |
| Fax |
|
| Email |
ideal.ankitsinha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
COL KRISHNA KUMAR M |
| Designation |
SENIOR ADVISOR |
| Affiliation |
AHRR, DELHI |
| Address |
DEPARTMENT OF ANAESTHESIA & INTENSIVE CARE, AHRR, DELHI
South
DELHI
110029
India |
| Phone |
9990457469 |
| Fax |
|
| Email |
krishnakm312@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankit Sinha |
| Designation |
Senior Resident |
| Affiliation |
AHRR, DELHI |
| Address |
MAIN ICU, 2ND FLOOR, ARMY HOSPITAL RESEARCH AND REFERRAL,DELHI
South
DELHI
110029
India |
| Phone |
9811329969 |
| Fax |
|
| Email |
ideal.ankitsinha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Army hospital research and referral,DELHI CANTT,DELHI-110010 |
|
|
Primary Sponsor
|
| Name |
ARMY HOSPITAL RESEARCH AND REFERRAL DELHI |
| Address |
ARMY HOSPITAL RESEARCH AND REFERRAL DELHI CANTT- 110010 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 ANKIT SINHA |
Army hospital Research and Referral |
Department of Academics Army Hospital Research and Referral Delhi Cantt-110010
Central
DELHI |
011-23338196
ideal.ankitsinha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,ARMY HOSPITAL RR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The study will include adult patients greater than 18 years to the ICU who are expected to require invasive mechanical ventilation for at least 48 hours |
|
| ExclusionCriteria |
| Details |
Patients with known tracheal/oesophageal injury, tracheostomy, pre existing pneumonia, or those enrolled in other clinical trials will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare the incidence of VAP in patients receiving continuous and intermittent subglottic suctioning in the ICU
2. To assess the impact of tracheal tube pressure on incidence of VAP in the ICU
|
Patients who are expected to be on mechanical ventilation for more than 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the impact of continuous and intermittent subglottic suction on the duration of mechanical ventilation, ICU length of stay, and mortality |
One and a half years |
|
|
Target Sample Size
|
Total Sample Size="178"
Sample Size from India="178"
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)
|
01/04/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This prospective randomised study aims to contribute valuable evidence to the ongoing debate surrounding the efficacy of continuous and intermittent subglottic suction in preventing VAP in ICU patients. The findings will have implications for clinical practices and may help improve patient outcomes and reduce the burden of VAP in critically ill patients on mechanical ventilation. |