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CTRI Number  CTRI/2024/03/064809 [Registered on: 27/03/2024] Trial Registered Prospectively
Last Modified On: 26/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Observational Study 
Study Design  Other 
Public Title of Study   Evaluation of practices of body temperature management before, during and after surgery in patients undergoing major abdominal surgery 
Scientific Title of Study   Practice pattern of perioperative temperature management in patients undergoing major abdominal surgery 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
4329_Version 1.1 dated 15.01.24  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vandana Agarwal 
Designation  Professor 
Affiliation  Tata memorial hospital 
Address  Department of anaesthesia critical care and pain, 2nd floor, Main Building, Tata Memorial Hospital, Dr E Borges marg, Parel Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177042  
Fax    
Email  vandanachaukar@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vandana Agarwal 
Designation  Professor 
Affiliation  Tata memorial hospital 
Address  Department of anaesthesia critical care and pain, 2nd floor, Main Building, Tata Memorial Hospital, Dr E Borges marg, Parel Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177042  
Fax    
Email  vandanachaukar@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sachin GS 
Designation  Junior Resident 
Affiliation  Tata memorial hospital 
Address  Department of anaesthesia critical care and pain, 2nd floor, Main Building, Tata Memorial Hospital, Dr E Borges marg, Parel Mumbai MAHARASHTRA 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9448563543  
Fax    
Email  Sachinshanth9@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Dr E Borges Road, Parel, Maharashtra- 400012 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dr Ernest Borges road, Parel East, Parel, Mumbai, Maharashtra, 400012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Not applicable   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vandana Agarwal  Tata Memorial Hospital  Department of Anaesthesia, Critical care and Pain, 2nd floor, OT complex and recovery area, Main Building, Tata Memorial Hospital, Dr E Borges marg, Parel Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 
02224177042

vandanachaukar@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Hospital_Institutional Ethics Committee I  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, (2) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, (3) ICD-10 Condition: C64-C68||Malignant neoplasms of urinary tract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  NA 
Comparator Agent  Nil  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Consenting patients more than 18 years of age, undergoing elective major abdominal procedures (gastrointestinal, urology, gynaecology, retroperitoneal resections and CRS with or without HIPEC.
2. Duration of surgery more than or equal to 2 hours 
 
ExclusionCriteria 
Details  1. Patients less than 18 years age.
2. Pregnant women.
3. Patients in whom core temperature cannot be monitored 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Incidence of hypothermia within 2 hours of anaesthesia induction  Preoperative and intraoperative with in 2 hours of anaesthesia induction 
 
Secondary Outcome  
Outcome  TimePoints 
1. Proportion of patients shifted to recovery/ ICU with hypothermia (Temperature less than 36°C)
2. Practice pattern of perioperative hypothermia management (use of active warming, grade of hypothermia during and after surgery, presence of shivering during recovery)
3. Unplanned ventilation secondary to hypothermia (Temperature less than 36°C) 
Peroperative, intraoperative and post operative until discharge from recovery room, and in case of pancreatic resections until discharge from hospital 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   08/04/2024 
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  

Introduction

 

Inadvertent perioperative hypothermia is a common complication of perioperative period. Perioperative hypothermia is defined as core body temperature less than 36°C. The incidence ranges between 60-90% of all surgical patients. Perioperative inadvertent hypothermia results from a combination of impaired regulation of temperature control mechanisms secondary to anaesthesia and exposure of body surface and cavities to cold operation room environment over a period. Inadvertent hypothermia is associated with increased bleeding, cardiovascular events, postoperative shivering and increased oxygen consumption, thermal discomfort, increased rate of surgical site infections (SSI) and delayed wound healing. Patients at high risk for developing perioperative inadvertent hypothermia fulfil any two of the following criteria.(1)

a) American Society of Anesthesiologists (ASA) grade II to V (the higher the grade, the greater the risk)
b) Preoperative temperature below 36.0°C (and preoperative warming is not possible because of clinical urgency)
c) Use of combined general and regional anaesthesia
d) Major or intermediate surgery
e) At risk of cardiovascular complications. 

 

In patients with cardiac disease undergoing non-cardiac surgery, perioperative normothermia was associated with reduced rates of major cardiac events and ventricular tachycardia.(2)American College of Cardiology and American Heart Association recommends maintenance of normothermia to reduce perioperative cardiac events in patients undergoing noncardiac surgery as class IIb.(3) Hypothermia within 2 hours of induction of anaesthesia (delayed hypothermia) was identified as an independent risk factor for developing severe hypothermia (temperature <35°C). Delayed hypothermia is associated with increased SSI and organ space infection (4)

 

Pre-warming initiated 30 min before induction of anaesthesia prevents rapid decline of core temperature that occurs due to redistribution.(5,6) Prewarming was also associated with normothermia in recovery (7). In a meta-analysis of RCT’s, active body surface warming systems (ABSW) (heating using air, water or gel) was associated with reduced blood loss, significant reduction in SSI, postoperative shivering and thermal discomfort. Forced air warming system was associated with reduced major cardiovascular events in patients with heart disease.(8) ABSW are associated with reduced blood loss, significant reduction in SSI, postoperative shivering and thermal discomfort (9). Therefore, active warming is superior to passive warming (10)

In addition to active warming, administration of warm fluids is associated with less shivering (11), in patients requiring >500 ml fluid volume.(12) National Institute for Health and Care Excellence (NICE) guidance recommends irrigation fluids used intraoperatively by surgeons should be warmed in a thermostatically controlled cabinet to a temperature of 38-40°C.(1). The purpose of this study is to audit current practice regarding perioperative temperaturemanagement in patients undergoing major abdominal surgery.

 

Aim 

To audit practice pattern of perioperative temperature management in patients undergoing major abdominal surgery.

 

Primary Objective

1. Incidence of hypothermia within 2 hours of anaesthesia induction

 

Secondary Objectives

1. Proportion of patients shifted to recovery/ ICU with hypothermia (Temperature <36°C)
2. Practice pattern of perioperative hypothermia management (use of active warming, grade of hypothermia during and after surgery, presence of shivering during recovery)
3. Unplanned ventilation secondary to hypothermia (Temperature <36°C)

 

Study design 

Prospective observational audit.

 

Material and Methods 

This study is a prospective observational study of perioperative temperature management following major abdominal surgery in Tata Memorial Hospital over a period of 5 months. Post Institutional ethics committee approval and CTRI registration; we will audit our current practice regarding perioperative temperature management in patients undergoing elective liver, pancreatic, urology, gynaecology, retroperitoneal resections and CRS with or without HIPEC procedures. Perioperative hypothermia is defined as follows:

Normothermia - > 36°C

Mild Hypothermia – 35.5°C-35.9°C

Moderate Hypothermia – 35°C-35.4°C

Severe hypothermia – <35°C

 

Inclusion criteria 

1. Consenting patients > 18 years of age, undergoing elective major abdominal procedures (gastrointestinal, urology, gynaecology, retroperitoneal resections and CRS with or without HIPEC. 
2. Duration of surgery > 2 hours 

 

Exclusion criteria 

1. Patients <18 years age. 
2. Pregnant women. 
3. Patients in whom core temperature cannot be monitored

 

We will record the following patient variables after the patient arrives in the operation room (OR). 

1. Demographic details 
2. Comorbidities if any 
3. ASA grade
4. Duration of anaesthesia
5. Duration of surgery
6. Minimally invasive surgery
7. Axillary temperature on arrival in the OR
8. Core temperature 2 hours after induction of anaesthesia
9. Intraoperative lowest temperature and duration since induction of anaesthesia
10. Maximum intraoperative temperature
11. Grade of hypothermia intraoperative (Lowest reading will be considered)
12. Devices used for perioperative temperature management
13. Intraoperative blood loss
14. Temperature before shifting to Recovery room/ ICU
15. Grade of hypothermia following RR/ICU admission 
16. Warming devices used intraoperatively
17. Unplanned ventilation due to hypothermia (Temp <36°C)
18. Presence of shivering in recovery room/ ICU
19. Need for medication to control shivering if any
20. Use of active warming in Recovery room/ICU
21. Postoperative complications in patients undergoing pancreatic resections.

 

Patients undergoing pancreatic resections will be followed up until discharge for postoperative complications if any by the study team. This is a non-interventional study with no patient contact. Source document for recording all parameters will be anaesthesia and ICU/RR monitoring charts and EMR notes.

 

Sample size

We will include consecutive patients undergoing major abdominal surgery over a period of 5 months. We will screen approximately 600 patients and enrol 400 patients during the study period (or whichever is earlier).

 

Statistical Methods 

Data will be presented as mean ± (SD), median (range), and frequency (percentage) where appropriate. We will analyse categorical data using the chi-square test or Fisher Exact test (for binary data). Similarly, for comparisons of two groups we will use independent sample t-test or Mann-Whitney U test as per the distribution of data. We will evaluate association between hypothermia and grades of hypothermia and postoperative complications in patients with pancreatic resection using categorical tests chi-square/ Mann Whitney U test depending on the distribution of data. Statistical significance is defined as P-value <0.05. For the purpose of thesis, data will be analysed in May 2024

 
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