| CTRI Number |
CTRI/2023/03/050983 [Registered on: 22/03/2023] Trial Registered Prospectively |
| Last Modified On: |
04/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the effectiveness of ETT with Subglottic suction device in prevention of VAP over conventional ET tube |
|
Scientific Title of Study
|
Intermittent subglottic suction for prevention of Ventilator associated pneumonia in emergency medical patients-an open label parallel group
randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr pallvi |
| Designation |
Jr Medicine ( department of internal medicine) |
| Affiliation |
PGIMER Chandigarh |
| Address |
Sector 12 Sanjeevani girls hostel PGIMER s block room no 38
Sector 12 Sanjeevani girls hostel PGIMER
Chandigarh
CHANDIGARH
Dr Pallvi PGIMER
India |
| Phone |
8278772101 |
| Fax |
|
| Email |
pallvibhardwaj56@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh c sharda |
| Designation |
Assistant professor internal medicine |
| Affiliation |
PGIMER Chandigarh |
| Address |
Medicine office 4th floor nehru hospital PGIMER sector 12
Medicine office 4th floor nehru hospital PGIMER sector 12
Chandigarh
CHANDIGARH
160017
India |
| Phone |
9868404808 |
| Fax |
|
| Email |
saurabhcsharda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurabh c sharda |
| Designation |
Assistant professor internal Medicine |
| Affiliation |
PGIMER Chandigarh |
| Address |
Medicine office 4th floor Nehru hospital PGIMER Chandigarh sector 12
Medicine office 4th floor Nehru hospital PGIMER chandigarh sector 12
Chandigarh
CHANDIGARH
176001
India |
| Phone |
9868404808 |
| Fax |
|
| Email |
saurabhcsharda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Special research thesis grant Deptt of internal medicine PGIMER Chandigarh |
|
|
Primary Sponsor
|
| Name |
Post graduate institute of medical education and research chandigarh |
| Address |
Post graduate institute of medical education and research chandigarh. Sector 12 Chandigarh |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr pallvi |
Sector 12 Sanjeevani hostel PGIMER |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pallvi |
PGIMER ( Nehru hospital) |
Emergency ward 22 under Emergency medicine OPD
Chandigarh
CHANDIGARH |
8278772101
Pallvibhardwaj56@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
intermitent subglottic suction
|
We plan to conduct a study with a group of patients receiving intermittent subglottic suction every 4-6 hours with standard ET care vs group receiving standard ET care. These suction will be sent for cultures and to match wether ET aspirate and these subglottic secretions have same organism growing if patient is suspected to develop VAP( fever, thick or purulent ET secretions and new infiltrate on chest x ray or CT scan. The other comparator group won’t receive any subglottic suction.. The patient will be observed for this study for 14 days |
| Comparator Agent |
Intermittent subglottic suction |
The comparator group won’t receive any intermittent suctioning.
In this study model these comparator agent/ control will receive only standard endotracheal tube care instead of intermittent subglottic suction and standard ET care in intervention group.
Patient will have a follow up of 14 days. These patient will receive treatment as standard treatment protocol for given disease. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.90 Year(s) |
| Gender |
Both |
| Details |
Neurological symptoms
CVS symptoms
sepsis and MODS
Poisoning patients
Snake venum patients |
|
| ExclusionCriteria |
| Details |
1. community acquired pneumonia
2. Hospital acquired pneumonia
3. ARDS
4. Immunocompromised hosts
5. Trauma patients
6. Pregnant females
7. Surgical patients
8. COVID positive patients
9. Intubated outside PGIMER |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of VAP |
14days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary VAP
Length of stay
Duration of ventilation |
14 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
Modification(s)
|
28/03/2023 |
| 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="1"
Months="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Nill |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an open label parallel group randomised control trial to study the effect of subglottic suction device(SSD) with intermittent subglottic suction in prevention of VAP. This study focus on incidence of VAP in the group receiving SSD vs patient with standard ET care. |