CTRI Number |
CTRI/2011/06/001840 [Registered on: 28/06/2011] Trial Registered Prospectively |
Last Modified On: |
31/05/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Medical Device |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Role of suctioning airway secretions in reducing lung infection in ICU patients requiring artificial breathing. |
Scientific Title of Study
|
Role of subglottic suctioning in the prevention of ventilator associated pneumonia in critically ill patients requiring invasive mechanical ventilation in a tertiary care hospital in South India. |
Trial Acronym |
SVAPP |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DrVarsha Kiron |
Designation |
PG Registrar |
Affiliation |
|
Address |
Department of General Medicine
Christian Medical College
Vellore-632004
Vellore TAMIL NADU 632004 India |
Phone |
|
Fax |
|
Email |
kironvarsha@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DrJohn Victor Peter |
Designation |
Associate Professor |
Affiliation |
|
Address |
Department of Critical Care
Christian Medical College
Vellore-632004
Vellore TAMIL NADU 632004 India |
Phone |
|
Fax |
|
Email |
peterjohnvictor@yahoo.com.au |
|
Details of Contact Person Public Query
|
Name |
DrVarsha Kiron |
Designation |
PG Registrar |
Affiliation |
|
Address |
Department of General Medicine
Christian Medical College
Vellore-632004
TAMIL NADU 632004 India |
Phone |
|
Fax |
|
Email |
kironvarsha@gmail.com |
|
Source of Monetary or Material Support
|
Covidien Healthcare India Private Ltd.
Doshi Towers 6th floor
156,Poonamalle High Road
Chennai
600010 |
|
Primary Sponsor
|
Name |
Christian Medical College |
Address |
Christian Medical College
Ida Scudder Road
Vellore
Tamilnadu-632004 |
Type of Sponsor |
Private 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 |
DrVarsha Kiron |
Christian Medical College |
Medical Intensive Care Unit
Department of Critical Care
Christian Medical College
Vellore
Vellore TAMIL NADU |
09894365503
kironvarsha@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL REVIEW BOARD, CHRISTIAN MEDICAL COLLEGE, VELLORE |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Ventilator associated pneumonia
, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
routine endotracheal suctioning |
Routine endotracheal suctioning involves a sterile catheter insertion through the endotracheal tube into the airway and clearing the secretions in the larynx. This however does not clear the pool of secretions in the subglottic space which is known to harbor pathogenic organisms responsible for causing ventilator associated pneumonia. |
Intervention |
Subglottic suctioning in addition to routine endoracheal suctioning |
Subglottic suctioning involves clearance of the sectretions which get accumulated between the inflated bulb of the endotracheal tube and the vocal cords. This site is not accessible routinely however the Hi Lo EVAC tubes contain additional port opening in the subglottic space enabling the suction of secretions. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
80.00 Day(s) |
Gender |
Both |
Details |
All patients requiring Medical ICU admission for invasive mechanical ventilation will be recruited into the study. |
|
ExclusionCriteria |
Details |
Patients who are intubated elsewhere and are referred to CMC for admission are excluded from the trial.
Patients admitted to ICU for Non-invasive ventilation alone are excluded.
Tracheostomised patients are excluded |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Incidence of Ventilator associated pneumonia. |
During the ICU stay. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Time to VAP diagnosis
Mortality rate
Duration of ICU stay |
During ICU stay |
|
Target Sample Size
|
Total Sample Size="320" Sample Size from India="320"
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
|
Phase 3 |
Date of First Enrollment (India)
|
01/07/2011 |
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="0" Months="8" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Suspended |
Recruitment Status of Trial (India) |
Suspended |
Publication Details
|
None as yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
This study is to assess
the role of subglottic suctioning in patients requiring mechanical ventilation
in the Medical ICU. As a part of
standard care in intubated patients, the secretions from the respiratory tract are
periodically suctioned through the endotracheal tube using sterile suction
catheters. However it was shown in multiple observational studies that the
subglottic space between the vocal cords and the bulb of the ET tube harbors a
pool of secretions that are not accessible for routine suctioning. This pool of
secretions forms a focus for colonization of various bacteria which are shown
to be responsible for Ventilator Associated Pneumonia (VAP). VAP prolongs the
duration of ICU stay as well the mortality of the patient. Also the financial burden due to a VAP is not
only the cost of additional ICU stay but also the second line antibiotics which
are often used in its treatment.
The central idea of this
study is an intervention enabling the clearance of the subglottic pool of
secretions and its ability in prevention of VAP. Patients will be randomized to
get either routine endotracheal suctioning alone or subglottic suctioning in
addition to the routine endotracheal suctioning. Subglottic suctioning is done
through a port which opens into the subglottic region in specially designed ET
tubes. Multiple randomized control trials world over have shown benefit with
subglottic suctioning in the prevention of VAP, however data from a developing
countries is lacking. We aim to show improved rates of VAP per ventilator days.
|