| CTRI Number |
CTRI/2012/08/002937 [Registered on: 30/08/2012] Trial Registered Retrospectively |
| Last Modified On: |
09/08/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Audit on Perioperative mortality and significant morbidity |
|
Scientific Title of Study
|
Audit on Perioperative mortality and significant morbidity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Project no 923 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayana S Amin |
| Designation |
Associate Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anaesthesiology, Critical Care and Pain, Tata Memorial Hospital, Dr Ernest Borges Marg, Parel, Mumbai
Department of Anaesthesiology, Critical Care and Pain, Tata Memorial Hospital, Dr Ernest Borges Marg, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
91-9820742327 |
| Fax |
022-24146937 |
| Email |
drnayana_sa@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayana S Amin |
| Designation |
Associate Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anaesthesiology, Critical Care and Pain, Tata Memorial Hospital, Dr Ernest Borges Marg, Parel, Mumbai
Department of Anaesthesiology, Critical Care and Pain, Tata Memorial Hospital, Dr Ernest Borges Marg, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
91-9820742327 |
| Fax |
022-24146937 |
| Email |
drnayana_sa@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nayana S Amin |
| Designation |
Associate Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anaesthesiology, Critical Care and Pain, Tata Memorial Hospital, Dr Ernest Borges Marg, Parel, Mumbai
Department of Anaesthesiology, Critical Care and Pain, Tata Memorial Hospital, Dr Ernest Borges Marg, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
91-9820742327 |
| Fax |
022-24146937 |
| Email |
drnayana_sa@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Not applicable] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not applicable |
NA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nayana S Amin |
Tata Memorial Hospital |
Department of Anaesthesiology, Critical Care and Pain, Tata Memorial Hospital,
Dr Ernest Borges Marg, Parel, Mumbai-400012
Mumbai
MAHARASHTRA |
91-9820742327
drnayana_sa@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethics Committee, Tata Memorial Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Post operative patients, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Post surgical patients with morbidity. Morbidity has been defined as patients requiring any intervention in the immediate post-operative period. (reintubation, ventilation, vasoactive agents, insulin infusion, pain management, fluid management, evidence of organ hypoperfusion)
ICU/RR stay >24hrs
ICU/RR readmission in post surgical patients during present hospital admission
Resurgery during present hospital admission
post surgical mortality during present hospital admission |
|
| ExclusionCriteria |
| Details |
Postsurgical patients without any morbidity |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To see our overall Perioperative morbidity and mortality rates
The incidence of Anaesthesia related morbidity and mortality
|
Anytime during present hospital admission
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of ICU stay in patients with significant morbidity or mortality (ICU/RR stay24hrs or death within24hrs)
Duration of hospital stay in patients with morbidity or mortality
ICU Readmission rates
Re-exploration rates
|
Anytime during the present hospital admission |
|
|
Target Sample Size
|
Total Sample Size="800"
Sample Size from India="800"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2011 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Anaesthesia has the potential to induce physiological changes that may lead to morbidity and mortality. However in recent years anaesthesia is relatively safe and there are few perioperative adverse events directly related to anaesthesia. This is because of better monitoring techniques and the use of practice guidelines.Evaluation of perioperative morbidity and mortality provides knowledge of quality of anaesthesia management. |