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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  
Tata Memorial Centre 
 
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 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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 
 
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.
 
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