| CTRI Number |
CTRI/2021/09/036640 [Registered on: 20/09/2021] Trial Registered Prospectively |
| Last Modified On: |
17/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of subglottic suctioning in patients on ventilator on pneumonia that is due to ventilatory support |
|
Scientific Title of Study
|
Effect of subglottic suctioning in intubated patients on the incidence of ventilator associated pneumonia: A randomized controlled study |
| Trial Acronym |
Subglottic suction in VAP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr B K Rao |
| Designation |
Senior Cosultant |
| Affiliation |
Sir Gangaram hospital |
| Address |
Department of Critical Care Medicine
Sir Gangaram Hospital
Old Rajinder nagar
New Delhi
New Delhi
DELHI
110060
India |
| Phone |
9811177755 |
| Fax |
|
| Email |
drbkrao@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B K Rao |
| Designation |
Senior Cosultant |
| Affiliation |
Sir Gangaram hospital |
| Address |
Department of Critical Care Medicine
Sir Gangaram Hospital
Old Rajinder nagar
New Delhi
New Delhi
DELHI
110060
India |
| Phone |
9811177755 |
| Fax |
|
| Email |
drbkrao@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr B K Rao |
| Designation |
Senior Cosultant |
| Affiliation |
Sir Gangaram hospital |
| Address |
Department of Critical Care Medicine
Sir Gangaram Hospital
Old Rajinder nagar
New Delhi
New Delhi
DELHI
110060
India |
| Phone |
9811177755 |
| Fax |
|
| Email |
drbkrao@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Critical care medicine
Sir Gangaram hospital |
|
|
Primary Sponsor
|
| Name |
sir Gangaram hospital |
| Address |
sir Gangaram hospital, New Delhi |
| Type of Sponsor |
Other [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 Priya Gupta |
Sir Ganga Ram hospital |
Intensive Care Unit, SSRB 4th floor
New Delhi
DELHI |
9992996985
priyagupta0905@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee Sir Gangaram Hospital |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: J989||Respiratory disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No subglottic suction |
No Subglottic suctioning will be done in this group |
| Intervention |
Sublottic suction |
Subglottic suction through subglottic suction port endotracheal tube every 2 hourly will the intervention |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Requiring mechanical ventilation for more than 48 hours
Without suspected or confirmed community or hospital acquired pneumonia |
|
| ExclusionCriteria |
| Details |
Prior intubation or tracheostomy |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of ventilator associated pneumonia |
Upto 28 days after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of mechanical ventilation and ICU stay, Rate of microbiological positive culture in VAP patients, ICU mortality |
uptown 28 days after intubation |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
27/09/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is a randomized controlled interventional open labelled study conducted on patients of age 18-70 years requiring mechanical ventilation for more than 48 hours. 100 patients will be enrolled divide into two group of 50 patients each- Control group intubated with conventional endotracheal tube and test group with subglottic suction port endotracheal tube. Intervention will be subglottic suction done every 2 hourly in test group. Ventilator bundles will be applied in both the groups. Screening for ventilator associated pneumonia will be done for 28 days by NHSN PNU 1 definition. Primary outcome will be the incidence of ventilator associated pneumonia and secondary outcome will be duration of mechanical ventilation and ICU stay, Rate of microbiological positive culture in VAP patients and ICU mortality. Outcomes will be analyzed in both the groups. |