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CTRI Number  CTRI/2024/02/062966 [Registered on: 21/02/2024] Trial Registered Prospectively
Last Modified On: 01/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   an observational study to find out the rate of occurrence of a decrease in body temperature occurring during cancer surgery in children and the factors responsible for it for improving quality in providing standard of care in our hospital.  
Scientific Title of Study   INCIDENCE AND RISK FACTORS FOR INTRAOPERATIVE HYPOTHERMIA IN CHILDREN UNDERGOING SURGERY FOR CANCER - A QUALITY IMPROVEMENT AUDIT. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Project no 4299 Version 1.0 dated 20 July 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nayana Amin 
Designation  Professor 
Affiliation  Tata Memorial Hospital, Mumbai 
Address  Department of Anesthesia, Critical Care and Pain, Main Building, Second floor, Dr E Borges Road, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9820742327  
Fax    
Email  drnayana.amin@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nayana Amin 
Designation  Professor 
Affiliation  Tata Memorial Hospital, Mumbai 
Address  Department of Anesthesia, Critical Care and Pain, Main Building, Second floor, Dr E Borges Road, Parel, Mumbai


MAHARASHTRA
400012
India 
Phone  9820742327  
Fax    
Email  drnayana.amin@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Harshwardhan Masal 
Designation  Junior Resident 
Affiliation  Tata Memorial Hospital, Mumbai 
Address  Department of Anesthesia, Critical Care and Pain, Main Building, Second floor, Dr E Borges Road, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9284104191  
Fax    
Email  harshwardhanmasal@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai, Maharashtra 400012 
 
Primary Sponsor  
Name  Tata Memorial Hospital,Mumbai 
Address  Dr E Borges Road, Parel, Mumbai, Maharashtra 400012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Not Any  Not Any 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hrshawardhan Masal  Tata Memorial Hospital, Mumbai  OT Room NO 1 to 27a, Major OT complex, Department of Anesthesia, Critical Care and Pain,Second Floor, Main Building,Tata Memorial Hospital Dr E Borges Road, Parel
Mumbai
MAHARASHTRA 
9284104191

harshwardhanmasal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Centre- Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T885||Other complications of anesthesia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. Participant age less than 18 years
2. All surgeries in children lasting for more than 30 minutes 
 
ExclusionCriteria 
Details  1.Emergency surgeries
2.Surgeries where temperature monitoring has not been done
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
incidence and severity of intraoperative hypothermia in children undergoing oncosurgical procedures.  1 year after the start of the enrollment 
 
Secondary Outcome  
Outcome  TimePoints 
evaluate current practice of preventing intraoperative hypothermia  1 year after the start of the enrollment 
risk factors associated with perioperative hypothermia.   1 year after the start of the enrollment 
rate of the occurrence of complications associated with warming measures during surgeries   1 year after the start of the enrollment 
association between intraoperative hypothermia and postoperative complications (Clavien Dindo classification) following oncosurgery in children.  1 year after the start of the enrollment 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   01/03/2024 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Background:

Hypothermia is defined as core body temperature < 36ËšC(Normal body temperature: 36.5°C to 37.5°C).Hypothermia can be further classified as mild (when body temperature is 35.0-36°C, moderate (when body temperature is 33-34.9°C and severe (when body temperature is <33°C. During surgery hypothermia can result due to heat loss from the patient’s body either by conduction, radiation, convection or evaporation. Conduction is the physical transmission of heat from the patient to another item, like a bed or theatre table. Radiation is the heat that a patient’s metabolism produces and emits. Convection is the process by which air travels about the patient to dissipate heat. Evaporation, which happens continuously as the patient breathes. Exposure to the cold operating room and evaporative losses further exacerbate the issue as anaesthesia affects the body’s ability to regulate its internal temperature, causing core-heat redistribution and heat loss to the environment.

Hypothermia during surgery causes many pathophysiological changes.The circulatory, adrenergic, and respiratory systems are all affected by prolonged hypothermia. Moderate hypothermia even delays the time it takes to recover from anaesthesia and the metabolism of anaesthetics and neuromuscular blocking drugs resulting in unplanned postoperative ventilation. Ventricular dysrhythmias are more likely when the sympathetic nervous system is stimulated in response to cold and when serum potassium levels change. Additionally, hypothermia changes the coagulation cascade and platelet function, increasing bleeding. Vasoconstriction-induced tissue hypoxia can cause a wound to take longer to heal. Also patients are more vulnerable to developing an infection at the surgical site because hypothermia inhibits neutrophil activity and reduces the effectiveness of macrophages and lymphocytes.

Infants and children are at a greater risk to develop hypothermia as they have less effective regulatory capacity, limited subcutaneous fat stores and differences in body size. Few studies have reported 4.5%-50% incidence of perioperative hypothermia in children. Reports of pediatric outcomes resulting from perioperative hypothermia are limited.

Peri-operative hypothermia is a silent and often missed factor which may contribute to adverse post operative outcomes like delay in surgical site wound healing, increased risk of wound infection, delayed recovery, prolonged ICU or hospital stay and increased mortality.Therefore, perioperative temperature monitoring and use of various measures (cutaneous warming systems like under surface warming mattress and warming blankets and fluid warming devices) to avoid intraoperative hypothermia are important quality improvement measures aimed to optimize surgical care and improve perioperative outcomes.

Study Design: This study is a prospective observational study as a part of dissertation in Tata Memorial Hospital for the period of 1 year. This study will be carried out after obtaining approval from the Institutional Ethics committee and CTRI registration

Study methodology:

 

Data will be collected from all eligible patients. All children will receive anaesthesia according to the current standard of care. All children coming for surgery are premedicated and taken in the OT. The OT table is pre warmed with a warming blanket before taking the patient in. Standard monitors (Electrocardiogram, noninvasive blood pressure and pulse oximetry) are attached according to the ASA guidelines. After induction of anesthesia temperature monitoring will be done with either an esophageal or surface temperature probe. The need for invasive blood pressure monitoring and regional anaesthesia techniques for pain management will be decided by the anaesthesiologist conducting the case.Forced air warming blankets and fluid warmers will be used to prevent intraoperative hypothermia. This is our current standard of care and no additional interventions will be done for the purpose of the study. We are just auditing our current practice of perioperative temperature regulation. Data will be collected from the electronic records of all the children undergoing elective surgery at Tata Memorial Centre.

 

The following data will be collected

 

Demographic data

 

·         Age and gender

·         Height weight and BMI

 

Intra - operative information

 

-    Type of anaesthesia: General anaesthesia(GA) / Regional anaesthesia (RA) / GA+RA.

-    Temperature monitoring method – Core temperature/Surface temperature

-    Method of active warming used – fluid warmers, warming blankets, other measures

-    Temperature at the start and end of anaesthesia

-    Hourly temperature recorded for the duration of surgery

-    Minimum and maximum intra-operative temperature

-    Duration of hypothermia

-    Need to stop active warming

-    Intraoperative blood loss

-    Intraoperative complications – arrhythmia, bleeding, hypotension needing vasopressors

-    Details of surgery

o   Grade of surgery- Minor /Intermediate/Major

o   Site of surgery – Cavity surgery / surface surgery

-    Duration of surgery and anaesthesia

 

Post-operative information

 

-    Post op core temperature

-    Need for active warming device

-    Unplanned mechanical ventilation

-    Delay recovery

-    Complications according to Clavien Dindo classification

-    ICU stay

-    Hospital stay

All patients included in the study will be followed up by the study team till discharge from the hospital.No biological samples will be taken from the patient. No additional hospital visits will be required.There are no stop points or withdrawal criteria.

Statistical Analysis:

Categorical variables will be expressed as percentages. Data for continuous variables will be expressed as mean (SD) with range (minimum ± maximum values). Univariate and multivariate logistic regression analysis will be done to see if there is any association between intraoperative hypothermia and age, BMI, duration of surgery, grade of surgery, site of surgery, warming measures, blood loss and intraoperative complications. Data will be presented as mean value + SD unless otherwise indicated and P < 0.05 will be considered significant. Analysis will be done using SPSS version 25 (IBM Corp. Released in 2017. IBM SPSS Statistics for Windows, Version 25).

 

 
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