| CTRI Number |
CTRI/2020/06/026145 [Registered on: 25/06/2020] Trial Registered Prospectively |
| Last Modified On: |
28/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Incidence and risk factors of low body temperature during surgery in adults undergoing cancer surgery- A quality improvement audit |
|
Scientific Title of Study
|
Incidence and risk factors of perioperative hypothermia in adults undergoing cancer surgery- A quality improvement audit |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayana Amin |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anaesthesiology, Critical Care and Pain,
2nd Floor Main Building,
Tata Memorial Hospital,
Dr.E.Borges Road,
Parel,
Mumbai.
Mumbai MAHARASHTRA 400012 India |
| Phone |
02224177057 |
| Fax |
|
| Email |
drnayana.amin@yahoo.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Roshni Ravichandran |
| Designation |
Post graduate student |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anaesthesiology, Critical Care and Pain,
2nd Floor Main Building,
Tata Memorial Hospital,
Dr.E.Borges Road,
Parel,
Mumbai.
Mumbai MAHARASHTRA 400012 India |
| Phone |
9535678020 |
| Fax |
|
| Email |
drroshniravichandran@gmail.com |
|
Details of Contact Person Public Query
Modification(s)
|
| Name |
Dr Nayana Amin |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anaesthesiology, Critical Care and Pain,
2nd Floor Main Building,
Tata Memorial Hospital,
Dr.E.Borges Road,
Parel,
Mumbai. Department of Anaesthesiology, Critical Care and Pain, 2nd Floor Main Building, Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai-400012 Mumbai MAHARASHTRA 400012 India |
| Phone |
02224177057 |
| Fax |
|
| Email |
drnayana.amin@yahoo.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Department of Anaesthesiology, Critical Care and Pain,
2nd Floor Main Building,
Tata Memorial Hospital,
Dr.E.Borges Road,
Parel,
Mumbai. |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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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 Amin |
Tata Memorial Hospital (TMH) |
Department of Anaesthesia, Critical Care and Pain,
2nd Floor Main Building,
Tata Memorial Hospital,
Dr.E.Borges Road,
Parel,
Mumbai. Mumbai MAHARASHTRA |
9820742327
drnayana.amin@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All surgeries lasting more than 30 mins |
|
| ExclusionCriteria |
| Details |
Emergency surgeries
Day care procedures
Patients needing therapeutic hypothermia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To analyse the incidence of perioperative hypothermia in adult patients undergoing cancer surgery. |
1. After induction of anaesthesia
2. During the surgery hourly analysis
3. Before shifting the patient out of the operation theatre
4. Immediately after the surgery in the recovery room |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To identify the risk factors for perioperative hypothermia.
To observe incidence of adverse outcomes of perioperative hypothermia like intra operative arrhythmia, blood loss, delayed recovery from anaesthesia /neuromuscular blockade, unplanned post op ventilator support, post-op shivering, surgical site infection, prolonged ICU stay, prolonged hospital stay. The study will also observe if there are any complications like hyperthermia and thermal injury due to the warming measures. |
1. During the surgery
2. Immediate post operative period |
|
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Target Sample Size
|
Total Sample Size="2000" Sample Size from India="2000"
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)
|
28/06/2020 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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)?
|
|
Brief Summary
|
Anaesthesia (either general or neuraxial) is known to impair the thermoregulatory mechanisms that maintain the body temperature. As a result of this anaesthetised patients who are not warmed can become hypothermic with a temperature drop of 1- 2 °C. Hypothermia is defined as core body temperature < 36 ̊C. Hypothermia causes many pathophysiological changes like respiratory depression due to altered drug metabolism, increased oxygen demands, arrhythmias, myocardial ischaemia, tissue hypoxia, metabolic acidosis, and coagulopathy.Hypothermia is a silent and often missed factor with adverse post operative out- comes like delayed recovery, adverse cardiac events, increased risk of wound infection, delay in surgical site wound healing, increased transfusion requirements, patient discomfort due to shivering, prolonged ICU or hospital stay. Hence it is very important to maintain normothermia during the perioperative period.This study therefore aims to analyse incidence of perioperative hypothermia in cancer surgeries along with its risk factors and adverse effects like intra-operative arrhythmia, blood loss, delayed recovery from anaesthesia or neuromuscular blockade, unplanned post op ventilator support, post-op shivering, surgical site infection, prolonged ICU stay, prolonged hospital stay. We will also see if there are any complications like hyperthermia and thermal injury due to the warming measures.The results of this quality improvement audit would help in developing institution specific protocols for preventing perioperative hypothermia and improving patient care. |