| CTRI Number |
CTRI/2012/07/002837 [Registered on: 27/07/2012] Trial Registered Retrospectively |
| Last Modified On: |
26/07/2012 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Rapid Response Team Activation in Medical Emergencies on patient outcome |
|
Scientific Title of Study
|
Effect of Rapid Response Team Activation in Medical Emergencies on Patient Outcome: A Retrospective Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RRT 01 version 1.2 dated 22-06-12 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohammed Fayyaz Rashid |
| Designation |
Clinical Research Trainee |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Clinical Research Department 6th floor
Max Super Speciality Hospital
2 Press Enclave Road Saket
New Delhi
Critical care Unit 6th floor
Max Super Speciality Hospital
1, Press Enclave Road Saket
New Delhi 110062
New Delhi
DELHI
110017
India |
| Phone |
9990156545 |
| Fax |
|
| Email |
mf_rashid27@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mohammed Fayyaz Rashid |
| Designation |
Clinical Research Trainee |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Clinical Research Department 6th floor
Max Super Speciality Hospital
2 Press Enclave Road Saket
New Delhi
Critical care Unit 6th floor
Max Super Speciality Hospital
1, Press Enclave Road Saket
New Delhi 110062
DELHI
110017
India |
| Phone |
9990156545 |
| Fax |
|
| Email |
mf_rashid27@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohammed Fayyaz Rashid |
| Designation |
Clinical Research Trainee |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Clinical Research Department 6th floor
Max Super Speciality Hospital
2 Press Enclave Road Saket
New Delhi
Critical care Unit 6th floor
Max Super Speciality Hospital
1, Press Enclave Road Saket
New Delhi 110062
DELHI
110017
India |
| Phone |
9990156545 |
| Fax |
|
| Email |
mf_rashid27@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Max Super Speciality Hospital |
|
|
Primary Sponsor
|
| Name |
Max super Speciality Hospital |
| Address |
Max super Speciality Hospital
2 Press Enclave Road Saket
New delhi 110017 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Yash Javeri |
Max super Speciality Hospital |
Critical Care Unit 6th floor
Max super Speciality Hospital
1 Press Enclave Road Saket
New delhi 110062
New Delhi
DELHI |
9818716943
yash.javeri@maxhealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Max Healthcare Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Emergency
, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All inpatients and outpatients requiring RRT activation for one or more of the following reasons:
•SPO2 Less than 90%
•SBP less < 90 mmHg or >180mmHg
•RR <8 or >28 per minute
•Acute mental status change
•Heart Rate <50 or >130 per minute
•Acute significant bleed
•New onset of chest pain
•Sudden loss of movement of face, arm or leg or Seizures
•Staff concerned/worried
|
|
| ExclusionCriteria |
| Details |
•RRT record form not completely filled.
•RRT record form unclear.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Determination of the status of patients after the Rapid Response Team activation in terms of the following:
a)Patient stayed in the room.
b)Patient shifted to ICU.
c)Occurrence of Code Blue Event.
d)Mortality.
e)Patient discharged
f)Length of stay in
ICU/Hospital
|
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| no secondary outcomes |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The Primary purpose of the study is to evaluate the effect of Rapid Response Team in medical emergencies on patient outcome. |