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
|
|
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
|
|
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. |