| CTRI Number |
CTRI/2025/09/094301 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
06/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of 10 minute prewarming before surgery on prevention of low body temperature in children |
|
Scientific Title of Study
|
Comparison of perioperative hypothermia with and without active short-term prewarming in paediatric patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prajjwal Angrish |
| Designation |
Junior resident |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar West,New Delhi
South DELHI 110029 India |
| Phone |
9805311644 |
| Fax |
|
| Email |
A9805311644@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Kavita Rani Sharma |
| Designation |
Director Professor and Head of Department |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar West,New Delhi
South DELHI 110029 India |
| Phone |
9968604376 |
| Fax |
|
| Email |
drkavitadn@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Kavita Rani Sharma |
| Designation |
Director Professor and Head of Department |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar West,New Delhi
DELHI 110029 India |
| Phone |
9968604376 |
| Fax |
|
| Email |
drkavitadn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia and intensive care, Vardhaman Mahavir medical College and
Safdarjung hospital, Ansari Nagar West, New Delhi,India. 110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of anaesthesia and intensive care, Vardhman Mahavir medical college and Safdarjung hospital, Ansari nagar West, New Delhi,India. 110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kavita Rani Sharma |
Vardhman Mahavir medical college and Safdarjung hospital |
operation theater 2, main OT complex, Department of anaesthesia and
intensive care, near New emergency building, Ansari
nagar West, New Delhi, India
110029
New Delhi
DELHI South DELHI |
9968604376
drkavitadn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vardhman Mahavir Medical College, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Active short term prewarming |
Application of active forced air warming device for 10 minutes before induction of anaesthesia in paediatric patients undergoing elective surgery. Continuous intraoperative warming with forced air warmer will be used until end of surgery. |
| Comparator Agent |
No active prewarming. |
Patients will receive standard perioperative care without active prewarming before induction. Continuous intraoperative warming with forced air warmer will be used until end of surgery. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
All paediatric patients who meet the standards of the American Society of Anaesthesiologists (ASA) grade I, II and aged between 1 to 12 years, undergo elective surgery under general anaesthesia.
Expected Duration of surgery 1 to 3 hours. |
|
| ExclusionCriteria |
| Details |
Preoperative core temperature more than 38°C |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of intraoperative hypothermia (core temperature less than 36°C). |
From induction of anaesthesia until end of surgery monitored every 10 minutes intraoperatively.
. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of postoperative shivering |
It will be measured in post anaesthetic care unit at arrival and at 1 hour post arrival using Wrench scoring system |
| Incidence of hypothermia at time of shifting to post anaesthetic care unit. |
It will be measured immediately after shifting the patient to the post anaesthetic care unit. |
| Core peripheral temperature gradient. |
It will be measured at beginning and end of surgery. |
| Degree of hypothermia which is duration of hypothermia and fall in temperature during total duration of surgery. |
It will be measured at the end of the surgery. |
|
|
Target Sample Size
|
Total Sample Size="66" Sample Size from India="66"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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="6" 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
|
Perioperative hypothermia defined as a core body temperature below 36C is a significant concern in surgical patients. It occurs in 50 to 90 percent of cases even during minor procedures. It is associated with complications including increased blood loss, higher infection risk, prolonged hospital stays, delayed wound healing and adverse cardiovascular effects. Paediatric patients are more vulnerable due to larger surface area to body mass ratio, less insulating fat, immature thermoregulation and increased heat loss. Despite active warming strategies like forced air warming blankets, infusion heating and increasing operating room temperature, studies report that nearly 65 percent of patients still develop hypothermia within the first hour of surgery. This is due to redistribution of heat after induction of anaesthesia. Prewarming increases peripheral tissue temperature and reduces redistribution. While traditional guidelines recommend 30 minutes, recent studies show even 10 minutes can be effective. However most existing literature is in adults and data in children is lacking. This study aims to investigate whether a 10 minute active prewarming protocol provides additional benefits for paediatric patients undergoing elective surgery with continuous intraoperative warming. The goal is to optimize perioperative temperature management, reduce incidence of perioperative hypothermia and improve recovery in children aged 1 to 12 years.
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