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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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