| CTRI Number |
CTRI/2024/12/078085 [Registered on: 13/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study of emergency calls for help in the operating rooms of a tertiary cancer institution. |
|
Scientific Title of Study
|
Prospective observational study of emergency calls for help in the operating rooms of a tertiary cancer institution.ECHO Study |
| 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 Malini Joshi |
| Designation |
Professor , Department of Anaesthesia , Critical Care and Pain, ACTREC, Tata Memorial Centre |
| Affiliation |
Tata Memorial Centre |
| Address |
ACTREC, Tata Memorial Centre , Sector 22, Kharghar, Navi Mumbai
Mumbai
MAHARASHTRA
410210
India |
| Phone |
9987226657 |
| Fax |
|
| Email |
jmalini2007@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Malini Joshi |
| Designation |
Professor , Department of Anaesthesia , Critical Care and Pain, ACTREC, Tata Memorial Centre |
| Affiliation |
Tata Memorial Centre |
| Address |
ACTREC, Tata Memorial Centre , Sector 22, Kharghar, Navi Mumbai
MAHARASHTRA
410210
India |
| Phone |
9987226657 |
| Fax |
|
| Email |
jmalini2007@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meghna Aherwar |
| Designation |
Junior Resident , Department of Anaesthesia, Critical Care and Pain, Tata Memorial Centre |
| Affiliation |
Tata Memorial Centre |
| Address |
Dept of Anaesthesiology, Critical Care and Pain, 7th floor, Rajarao Shodhika Building, ACTREC, Tata Memorial Centre, Sector 22, Kharghar, Navi Mumbai
Mumbai
MAHARASHTRA
410210
India |
| Phone |
8369474781 |
| Fax |
|
| Email |
drmeghnaaherwar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ACTREC Tata Memorial Centre |
| Address |
ACTREC Tata Memorial Centre, Sector 22, Kharghar Navi Mumbai. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Malini Joshi |
Tata Memorial Centre |
Dept of Anaesthesiology, Critical Care and Pain, 7th floor, Rajarao Shodhika Building, ACTREC, Tata Memorial Centre, Sector 22, Kharghar, Navi Mumbai
Mumbai
MAHARASHTRA |
9987226657
jmalini2007@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACTREC, Institutional Ethical Committee 3 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
NA |
| Comparator Agent |
Nil |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
The participants in this study is anyone from anaesthesia department (anaesthesia residents and consultants)who gives a call for help for patients undergoing elective surgeries in the OR including peripheral locations. This study will not look at the number of surgeries. We will only record the number of calls made during the study period of 1 year as a thesis project. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To quantify the rate and nature of calls for help in the OR of a tertiary cancer hospital. |
Data will be collected over a duration of 1 year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There is no secondary outcome |
NA |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
24/12/2024 |
| 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 Applicable |
| 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
|
The role of anaesthesiologists in the operating room is to manage critical events. It is a responsibility that is essential to our training and duty towards our patient. A call for help is defined as any situation in which the operating room anesthesia provider will require additional resources to manage the patient .Data on the number, nature and outcome of any critical event are routinely tracked by hospitals but no such data is collected for the operating room. Therefore,we wanted to conduct this study to quantify the rate and nature of calls for help in the operating room of a tertiary care cancer hospital. It is a prospective observational study to be conducted over a period of 1 year in the operating room of Tata Memorial Centre (ACTREC). The data will be collected from the case record form and there will be no direct patient contact. Data will be maintained securely and will not be disclosed at any point during the study. Interviews will be conducted with the OT personnel involved in the call being sent and accordingly the rate and nature of calls for help will be quantified. |