CTRI

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CTRI Number

CTRI/2025/07/091088 [Registered on: 17/07/2025] Trial Registered Prospectively

Last Modified On:

16/03/2026

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Single Arm Study

Public Title of Study

Study to Find Out Whether Upper or Lower Body Warmers Work Better to Prevent Body Temperature Drop During Lower Back Surgery

Scientific Title of Study

Effect of upper versus lower body forced air warming in preventing perioperative hypothermia in patients undergoing lumbar spine surgeries: An observational study

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Sanidhya N Rai
Designation	Post Graduate Student
Affiliation	Yenepoya School Of Allied Health Sciences
Address	Department of Anaesthesia and OT Technology Yenepoya School Of Allied Health Sciences Yenepoya (Deemed to be university) Derlakatte Mangalore Department of Anesthesiology, Yenepoya Medical College Hospital, Yenepoya (Deemed to be a University), Deralakatte Mangalore Dakshina Kannada KARNATAKA 575018 India
Phone	9353822252
Fax
Email	sanidhyarai87@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Shruthi R Nayak
Designation	Assistant Professor
Affiliation	Yenepoya Medical College Hospital
Address	Department of Anesthesiology, Yenepoya Medical College Hospital, Yenepoya (Deemed to be a University), Deralakatte Mangalore Dakshina Kannada KARNATAKA 575018 India
Phone	9449764601
Fax
Email	shrunayak1991@gmail.com

Details of Contact Person
Public Query

Name	Dr Shruthi R Nayak
Designation	Assistant Professor
Affiliation	Yenepoya Medical College Hospital
Address	Department of Anesthesiology, Yenepoya Medical College Hospital, Yenepoya (Deemed to be a University), Deralakatte Mangalore Dakshina Kannada KARNATAKA 575018 India
Phone	9449764601
Fax
Email	shrunayak1991@gmail.com

Source of Monetary or Material Support

Yenepoya Medical College,Yenepoya( Deemed to be university) Deralakatte,Mangalore, Dakshina Kannada, Karnataka,India 575018

Primary Sponsor

Name	Sanidhya N Rai
Address	Yenepoya School of Allied Health Science,Mudipu campus near Surya Tech Park Kayargoli,Kurnad Post Bantwal 575018
Type of Sponsor	Other [self]

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 Shruthi R Nayak	Yenepoya medical college hospital	Preoperative setting, operation theater complex, and postoperative ward, 6th floor, Department of Anaesthesiology Deralakatte Mangalore 575018 Dakshina Kannada KARNATAKA	9449764601 shrunayak1991@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Yenepoya Ethics Committee 4	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Patient undergoing lumbar Spine Surgeries Under General Anaesthesia With ASA 1 and 2

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil

Inclusion Criteria

Age From	19.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	Age 19 to 65 years American Society of Anesthesiologists physical status 1 and 2 ASA 1 A normal, healthy patient ASA 2 A patient with mild systemic disease

ExclusionCriteria

Details

Body mass index greater than 35 kg per meter square
Preoperative body temperature greater than 38 degree Celsius or smaller than 36 degrees Celsius
Pregnant women

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To compare the effectiveness of upper-body versus lower-body forced air warming in preventing perioperative hypothermia in patients undergoing lumbar spine surgery.	To compare the effectiveness of upper-body versus lower-body forced air warming in preventing perioperative hypothermia in patients undergoing lumbar spine surgery will be assessed at 30 minutes post-surgery

Secondary Outcome

Outcome	TimePoints
To evaluate perioperative temperature changes, incidence of shivering and postoperative thermal comfort in the patients To assess patient satisfaction with the method of forced air warming used during the intraoperative period.	The outcome will be assessed in the postoperative setting after 30 inutes of surgery

Target Sample Size

Total Sample Size="86"
Sample Size from India="86"
Final Enrollment numbers achieved (Total)= "86"
Final Enrollment numbers achieved (India)="86"

Phase of Trial

N/A

Date of First Enrollment (India)

27/07/2025

Date of Study Completion (India)

Date Missing

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="11"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Completed

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

Patients meeting the inclusion criteria will be selected, and informed consent will be obtained in the preoperative setting by the principal investigator. Baseline characteristics, including age, sex, BMI, ASA status, and will be recorded preoperatively. In the preoperative area, body temperature will be measured with a thermometer by the preoperative nurse, and also train the patients to use the thermal comfort scale. After transfer to the operating room, patients will be covered with a cotton blanket, and baseline vitals will be recorded. Following IV access, anaesthesia will be induced, and a nasopharyngeal probe will be inserted for core temperature monitoring. Standardized anaesthesia will be maintained with inhalational agents. After prone positioning, as per discretion of attending anesthesiologist either upper or lower body blanket is placed over the patient by the anaesthesia technician. In the upper warming group, the blanket will be placed above the T4 level, covering the back and both arms. In the lower warming group, the blanket will be positioned below the coccyx, covering both legs and the lower buttocks. Intraoperative warming will be provided via a forced-air warmer, with temperature readings recorded every 15 minutes by the PI. The warmer will be adjusted based on core temperature by the attending Anesthesiologist. If core temperature is less than 36.5 degree celsius then warming temperature is adjusted to 45 degree celsius, if core temperature is 36.5 to 37.5 degree celsius then warming temperature is adjusted to 40 degree celsius, and turned off if greater than 37.5 degree celsius. At the end of surgery, the forced-air warmer will be removed and the patient will be placed in the supine position, the patient is fully covered with a cotton blanket. After reversal from anaesthesia, the nasopharyngeal probe and tracheal tube will be removed. The patient is transferred to the post-anaesthesia care unit (PACU). The thermometer will be used to monitor temperature every 10 minutes (up to 30 min) by the post anaesthesia care nurse. Patients will rate shivering intensity (0=no shivering,1= intermittent, low intensity ,2=moderate shivering,3=continuous intense shivering) and thermal comfort (0mm=coldest imaginable,50mm=pleasant,100mm=warmest imaginable) every 10 minutes following arrival in the post anaesthesia care unit (PACU). Before discharge, Patient will rate their satisfaction with perioperative temperature management on a 5-point Likert scale (0=very dissatisfied, 1=dissatisfied, 2=neutral, 3=satisfied, 4=very satisfied). Additional data on adverse effects, blood loss, transfusions, anaesthesia time, unwarmed period, and fluid volume will be observed and data is collected by the principal investigator.