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CTRI Number  CTRI/2017/11/010587 [Registered on: 22/11/2017] Trial Registered Prospectively
Last Modified On: 21/11/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Other (Specify) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of clearing the secretions below the entry of windpipe( Trachea) in prevention of lung infection associated with breathing machine.  
Scientific Title of Study   Efficacy of subglottic suctioning in the prevention of ventilator associated pneumonia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Moses Charles Dsouza 
Designation  Professor & Head Of Surgical ICU 
Affiliation  St Johns medical college hospital 
Address  Department of Anaesthesia & Critical Care St Johns Medical college Hospital Bangalore



560079
Other 
Phone  7829000524  
Fax    
Email  drmosescharlesdsouza@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Moses Charles Dsouza 
Designation  Professor & Head Of Surgical ICU 
Affiliation  St Johns medical college hospital 
Address  Department of Anaesthesia & Critical Care St Johns Medical college Hospital Bangalore



560079
Other 
Phone  7829000524  
Fax    
Email  drmosescharlesdsouza@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Moses Charles Dsouza 
Designation  Professor & Head Of Surgical ICU 
Affiliation  St Johns medical college hospital 
Address  Department of Anaesthesia & Critical Care St Johns Medical college Hospital Bangalore



560079
Other 
Phone  7829000524  
Fax    
Email  drmosescharlesdsouza@gmail.com  
 
Source of Monetary or Material Support  
St Johns Medical College Hospital 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 
Dr Moses Charles DSouza  St. Johns medical college hospital  Department of Anaesthesiology,Surgical ICU (Division) Room number 12
Bangalore
KARNATAKA 
7829000524

drmosescharlesdsouza@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee St Johns Medical College and Hospital Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients who are admitted in the surgical Intensive Care unit,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group C (control)  Patients in this group will be intubated with a regular Endo tracheal tube 
Intervention  Group S (subglottic suction)  patients will be intubated with Endotracheal tube which has a port for subglottic suctioning  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All patients aged between 18-70 years who are expected to be ventilated for a duration of more than 72 hours.

 
 
ExclusionCriteria 
Details  1.Patients with pneumonia, Acute respiratory distress syndrome
2.Patients suspected to have pulmonary aspiration
3.Intubated patients received from another hospital
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome will be the incidence of Ventilator Associated Pneumonia (VAP).   Everyday at 10 AM from Day 1 to Day 14 the objective parameters are assessed



 
 
Secondary Outcome  
Outcome  TimePoints 
duration of ventilation, duration of ICU stay, addition of new antibiotics and 30 day mortality  Everyday at 10 AM from Day 1 to Day 30 the parameters are assessed
 
 
Target Sample Size   Total Sample Size="172"
Sample Size from India="172" 
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)   04/12/2017 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   1. Guihua C, Jing W, Chunyi L, et al. Subglottic secretion drainage and semirecumbent position for preventing ventilator associated pneumonia. Int J Clin Exp Med 2016;9(2):5193-5198 2. Muscedere J, Rewa O, Mckechnie K, et al. Subglottic secretion drainage for the prevention of ventilator-associated pneumonia: A systematic review and meta-analysis. Crit Care Med 2011; 39:1985-1991 3. Lorente L, Lecuona M, Jimenez A, et al. Subglottic secretion drainage and continuous control of cuff pressure used together save health care costs: American Journal of infection Control 2014; 42: 1101-1105 4. Damas P, Frippiat F, Ancion A, et al. Prevention of ventilator-associated pneumonia and ventilator associated conditions : A randomized controlled trial with subglottic secretion suctioning.Critical Care Medicine 2014 5.Ramos de Souza C, Taciana SV, Impact of supra-cuff suction on ventilator –associated pneumonia prevention. Rev Bras Ter Intensiva 2012; 24(4): 401-406 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Recruited 172 subjects will be  randomised into two  groups- groupC who will receive regular endotracheal tube and group S who will receive endotracheal tube with a port for subglottic suctioning.
The primary outcome is to note the incidence of ventilator associated pneumonia between the two groups. The objective measures noted for primary outcome are  : temperature, total count, secretions (clear/purulent),rales/bronchial breath sounds, inspired oxygen concentration (FiO2), PEEP, Chest X ray (infiltrate/consolidation) , microbiological analysis. These are recorded every day from Day 1 to Day14.
The secondary outcome is duration of ventilation, duration of ICU stay, addition of new antibiotics and 30 day mortality.
Data collected will be statistically analysed.
 
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