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CTRI Number  CTRI/2021/06/034389 [Registered on: 25/06/2021] Trial Registered Prospectively
Last Modified On: 21/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Observational Study 
Study Design  Other 
Public Title of Study   INTRAOPERATIVE TEMPERATURE MONITORING BY ZHF DEVICE AND NASOPHARYNGEAL TECHNIQUES IN PEDIATRIC PATIENTS 
Scientific Title of Study   COMPARISON OF INTRAOPERATIVE TEMPERATURE MONITORING BY ZHF DEVICE AND NASOPHARYNGEAL TECHNIQUES IN PEDIATRIC PATIENTS: A PROSPECTIVE , OBSERVATIONAL STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shilpa Goyal 
Designation  Additional Professor 
Affiliation  AIIMS JODHPUR 
Address  Department of Anaesthesia & Critical Care ,AIIMS JODHPUR Basni Phase 2, Jodhpur , Rajasthan
Department of Anaesthesia & Critical Care ,AIIMS JODHPUR Basni Phase 2, Jodhpur , Rajasthan
Jodhpur
RAJASTHAN
342005
India 
Phone  8003996880  
Fax    
Email  goyals@aiimsjodhpur.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Shilpa Goyal 
Designation  Additional Professor 
Affiliation  AIIMS JODHPUR 
Address  Department of Anaesthesia & Critical Care ,AIIMS JODHPUR Basni Phase 2, Jodhpur , Rajasthan
Department of Anaesthesia & Critical Care ,AIIMS JODHPUR Basni Phase 2, Jodhpur , Rajasthan
Jodhpur
RAJASTHAN
342005
India 
Phone  8003996880  
Fax    
Email  goyals@aiimsjodhpur.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Navin Vincent 
Designation  Junior Resident 
Affiliation  AIIMS JODHPUR 
Address  Department of Anaesthesia & Critical Care ,AIIMS JODHPUR Basni Phase 2, Jodhpur , Rajasthan
Department of Anaesthesia & Critical Care ,AIIMS JODHPUR Basni Phase 2, Jodhpur , Rajasthan
Jodhpur
RAJASTHAN
342005
India 
Phone  8921920414  
Fax    
Email  navincentp@gmail.com  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF MEDICAL SCIENCES.BASNI PHASE 2,JODHPUR 342005 
 
Primary Sponsor  
Name  AIIMS JODHPUR 
Address  BASNI INDUSTRIAL AREA , MIA 2ND PHASE BASNI,JODHPUR RAJASTHAN 342005 
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 Navin Vincent  AIIMS JODHPUR  Department of Anaesthesia & Critical Care ,AIIMS JODHPUR Basni Phase 2, Jodhpur , Rajasthan
Jodhpur
RAJASTHAN 		 8921920414

navincentp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE AIIMS JODHPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Pediatric patients of age 1 to 12 years,ASA grade I or II undergoing elective surgeries under general anaesthesia from the beginning of surgery till the end point 
 
ExclusionCriteria 
Details  Refusal of informed consent,fragile forehead skin,known allergy to probe material,hemodynamic instability,procedure impending probe placement 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the methods of temperature monitoring betweeen ZHF and Nasopharyngeal temperature monitoring devices  Baseline and then after every 15 minutes till the end of surgery  
 
Secondary Outcome  
Outcome  TimePoints 
To assesss the side effects due to application of these probes  Baseline : from beginning of surgery, then every 15min till end of surgery  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   30/06/2021 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [navincentp@gmail.com].

  6. For how long will this data be available start date provided 28-06-2023 and end date provided 28-02-2045?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   General anaesthesia can impair the thermoregulatory process and contribute to perioperative hypothermia. Intraoperative monitoring of core body temperature is thus recommended during general or neuraxial regional anaesthesia lasting >30 min .Perioperative temperature monitoring has prime importance in pediatric patients- a population particularly vulnerable to thermal variations as they loss a significant percentage of their core heat through conduction and radiation. Perioperatively these thermal variations are aggravated due to increased exposure of body surfaces and impaired physiologic compensatory mechanisms. Hence , adequate measurement of body core temperature is a prerequisite. Nasopharyngeal measurement has been shown to be a reliable method for core temperature monitoring, but it is not suitable in awake or head-injured patients.As an alternative the non-invasive ZHF sensor(3M SpotOn) , to be placed on forehead is composed of an isolating material that minimizes the heat loss from skin surface and a servo controlled heater able to reach skin temperature favoring the formation of an isothermal tunnel between the sensor and deep forehead. And as the temperatures equalize ,heat flow falls to zero and core temperature is measured.The present study aims to compare the ZHF sensor with the Nasopharyngeal probe with respect to their correlation, accuracy and precision in paediatric population undergoing surgery under General Anaesthesia. 
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