| CTRI Number |
CTRI/2023/04/051416 [Registered on: 10/04/2023] Trial Registered Prospectively |
| Last Modified On: |
06/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
The percentage of pneumonia with subglottic suction port endotracheal tube versus standard endotracheal tube in patients admitted in ICU |
|
Scientific Title of Study
|
INCIDENCE OF VENTILATOR ASSOCIATED PNEUMONIA (VAP) IN COMPARISON WITH ENDOTRACHEAL TUBE WITH SUBGLOTTIC SUCTION PORT VERSUS STANDARD ENDOTRACHEAL TUBE FOR PATIENTS ADMITTED IN ICU – A PROSPECTIVE OBSERVATIONAL STUDY†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SATYASISH KABI |
| Designation |
SENIOR RESIDENT (ACADEMIC) |
| Affiliation |
SHRI BALAJI INSTITUTE OF MEDICAL SCIENCES |
| Address |
SHRI BALAJI INSTITUTE OF MEDICAL SCIENCES MOWA RAIPUR
Department of critical care medical, 4th floor ICU
Raipur
CHHATTISGARH
492004
India |
| Phone |
9438640528 |
| Fax |
|
| Email |
satyasish.kabi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SATYASISH KABI |
| Designation |
SENIOR RESIDENT (ACADEMIC) |
| Affiliation |
SHRI BALAJI INSTITUTE OF MEDICAL SCIENCES |
| Address |
SHRI BALAJI INSTITUTE OF MEDICAL SCIENCES MOWA RAIPUR
Department of critical care medicine, 4th floor ICU
Raipur
CHHATTISGARH
492004
India |
| Phone |
9438640528 |
| Fax |
|
| Email |
satyasish.kabi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SATYASISH KABI |
| Designation |
SENIOR RESIDENT (ACADEMIC) |
| Affiliation |
SHRI BALAJI INSTITUTE OF MEDICAL SCIENCES |
| Address |
SHRI BALAJI INSTITUTE OF MEDICAL SCIENCES MOWA RAIPUR
Department of Critical Care medicine 4th floor ICU
Raipur
CHHATTISGARH
492004
India |
| Phone |
9438640528 |
| Fax |
|
| Email |
satyasish.kabi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR SATYASISH KABI |
| Address |
SHRI BALAJI INSTITUTE OF MEDICAL SCIENCES MOWA RAIPUR |
| Type of Sponsor |
Private medical college |
|
|
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 SATYASISH KABI |
SHRI BALAJI INSTITUTE OF MEDICAL SCIENCES |
Department of critical care medicine 4th floor ICU
Raipur
CHHATTISGARH |
9438640528
satyasish.kabi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE SBIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J17||Pneumonia in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients above 18 years of age
2. Patients ventilated for more than 48 hrs in ICU |
|
| ExclusionCriteria |
| Details |
1. Patients intubated outside hospital.
2. Patients suspected to have aspirated or at risk of aspiration prior to or during intubation.
3. Admitted with a diagnosis of community acquired pneumonia.
4. Pregnant women & Children.
5. Refusal of assent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of VAP or Ventilator Associated Pneumonia |
52 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
All VAEs - Ventilator Associated Events
• VAC-Ventilator Associated Condition ,
• IVAC- Infection related Ventilator Associated Condition ,
• Possible VAP- Ventilator Associated Pneumonia and
• Probable VAP- Ventilator Associated Pneumonia
• Duration of mechanical ventilation,
• Length of ICU stay,
• Length of hospital stay and
• In hospital mortality |
52 weeks |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
10/04/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1) To study the incidence of Ventilator Associated Pneumonia in both group of patients in general, 2) To study the incidence of Ventilator Associated Events such as, Ventilator Associated Condition (VAC), Infection related Ventilator Associated Complication (IVAC), Possible Ventilator Associated Pneumonia and Probable Ventilator Associated Pneumonia. 3) To study the (a) duration of mechanical ventilation, (b) duration of ICU stay and (c) duration hospital stay in both the groups 4) To find the in hospital mortality in both groups of patients. |