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Clinical Trials/CTRI/2021/06/034389
CTRI/2021/06/034389Not yet recruitingNot Applicable

COMPARISON OF INTRAOPERATIVE TEMPERATURE MONITORING BY ZHF DEVICE AND NASOPHARYNGEAL TECHNIQUES IN PEDIATRIC PATIENTS: A PROSPECTIVE , OBSERVATIONAL STUDY

AIIMS JODHPUR1 site in 1 country100 target enrollmentStarted: June 30, 2021Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
100
Locations
1
Primary Endpoint
To compare the methods of temperature monitoring betweeen ZHF and Nasopharyngeal temperature monitoring devices

Study Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
1.00 Year(s) to 12.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Refusal of informed consent,fragile forehead skin,known allergy to probe material,hemodynamic instability,procedure impending probe placement.

Outcomes

Primary Outcomes

To compare the methods of temperature monitoring betweeen ZHF and Nasopharyngeal temperature monitoring devices

Time Frame: Baseline and then after every 15 minutes till the end of surgery

Secondary Outcomes

  • To assesss the side effects due to application of these probes(Baseline : from beginning of surgery, then every 15min till end of surgery)

Investigators

Sponsor Class
Research institution and hospital

Study Sites (1)

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