| CTRI Number |
CTRI/2024/03/063868 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
07/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Compliance to quality indicators and its impact on outcome in mechanically ventilated patients. |
|
Scientific Title of Study
|
To study the compliance to quality indicators and its impact on outcome in mechanically ventilated patients. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr DEEPAK |
| Designation |
DrNB Resident |
| Affiliation |
Institute of Critical Care Medicine, Max Super Speciality Hospital, Saket, New Delhi 110017 |
| Address |
Onco Medical ICU, Doctor Duty Room, Department of Critical Care Medicine,Max Super Speciality Hospital, Press enclave road, Saket-110017,India
New Delhi
DELHI
110017
India |
| Phone |
9166699083 |
| Fax |
|
| Email |
deepakrajvikramsingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Omender Singh |
| Designation |
Principal Director |
| Affiliation |
Institute of Critical Care Medicine, Max Super Speciality Hospital, Saket, New Delhi 110017 |
| Address |
Onco Medical ICU, Doctor Duty Room, Department of Critical Care Medicine,Max Super Speciality Hospital, Press enclave road, Saket-110017,India
Onco Medical ICU, Doctor Duty Room, Department of Critical Care Medicine,Max Super Speciality Hospital, Press enclave road, Saket-110017,India
New Delhi
DELHI
110017
India |
| Phone |
9810734246 |
| Fax |
|
| Email |
omender.singh@maxhealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr DEEPAK |
| Designation |
DrNB Resident |
| Affiliation |
Institute of Critical Care Medicine, Max Super Speciality Hospital, Saket, New Delhi 110017 |
| Address |
Onco Medical ICU, Doctor Duty Room, Department of Critical Care Medicine,Max Super Speciality Hospital, Press enclave road, Saket-110017,India
New Delhi
DELHI
110017
India |
| Phone |
9166699083 |
| Fax |
|
| Email |
deepakrajvikramsingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Max Super Speciality Hospital, Saket, New Delhi 110017 |
|
|
Primary Sponsor
|
| Name |
Max Super Specialty Hospital |
| Address |
2nd Floor Onco Medical ICU, Doctor Duty Room,Department of Critical Care Medicine, Max Super Speciality Hospital, (A unit of Devki Devi Foundation) 2 Press Enclave Road, Saket, New Delhi 110017 India. |
| Type of Sponsor |
Other [Max Super Specialty Hospital Saket, New Delhi 110017 India] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepak |
Devki Devi Foundation Hospital (Max Healthcare) |
2nd Floor Onco MICU Devki Devi Foundation Hospital,a Unit of Max Healthcare,2 Press enclave Road,Saket Delhi 110017
New Delhi
DELHI |
9166699083
Deepakrajvikramsingh@gmail.com |
| Dr Deepak |
Max Super Speciality Hospital, Saket |
5th MICU , 6th MICU Max Super Speciality Hospital(A Unit of Maxhealthcare Institute Limited),West Block,1
Press enclave road, Saket, New Delhi 110017
New Delhi
DELHI |
9166699083
Deepakrajvikramsingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Devki Devi Foundation, Max Super Speciality Hospital |
Approved |
| Max Healthcare Ethics Committee, Max Super Speciality Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients admitted in the medical ICUs and on invasive ventilation will be eligible to be included in this study.
|
|
| ExclusionCriteria |
| Details |
Age less than 18yrs
Those who refuse consent
Those on IMV for less than 12 hours
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the compliance of various quality indices in mechanically ventilated ICU patients.
|
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To compare the compliance with international benchmarks.
2)Impact of raised P-peak pressures on incidence of barotrauma.
3)Impact of barotrauma on clinical outcome (ICU mortality, Days on IMV, Days in ICU.
4)Impact of VAP on clinical outcome (ICU mortality, Days on IMV, Days in ICU).
|
1 Year |
|
|
Target Sample Size
|
Total Sample Size="359"
Sample Size from India="359"
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)
|
15/03/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Routine measurement of quality indicators (QIs) through an Electronic Health Record (EHR) or registries are increasingly used to benchmark care and evaluate improvement interventions. However, existing indicators of quality for intensive care are derived almost exclusively from relatively narrow subsets of ICU patients from high-income healthcare systems. It is therefore becoming mandatory for the institutions to monitor quality indicators/parameters and compare their performance level with the national standard or international benchmarks. So the aim of this study is to measure and evaluate the quality markers and compare with the international benchmarks. We will select all adult patient admitted in medical ICU on ventilator and evaluate the incidence of various quality markers. |