| 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.
|