Intraoperative Body Core Temperature Monitoring: Oesophageal Probe vs Heated Controlled Servo Sensor

Completed

• Conditions: Temperature Change, Body; Surgery
• Interventions: Device: temperature monitoring

• Registration Number: NCT03820232
• Lead Sponsor: Careggi Hospital

Brief Summary

Monitoring of intraoperative core temperature is essential for patient safety, reducing the risk of perioperative hypothermia. A recently developed measuring system, SpotOn® (3M, St. Paul, MN), measures the core temperature in a non-invasive manner. Its accuracy in patients undergoing general surgery has not been investigated yet. The study was aimed at comparing the accuracy of the SpotOn® in comparison with the oesophageal probe which is considered the current standard in our care units.

Detailed Description

Monitoring of intraoperative core temperature is essential for patient safety, reducing the risk of perioperative hypothermia. A recently developed measuring system, SpotOn® (3M, St. Paul, MN), measures the core temperature in a non-invasive manner. Its accuracy in patients undergoing general surgery has not been investigated yet. The study was aimed at comparing the accuracy of the SpotOn® in comparison with the oesophageal probe which is considered the current standard in our care units. In this study, patients who were candidates for major or urological surgery will be considered eligible for enrollment. The core body temperature will be thus measured with both a single-use oesophageal probe and a SpotOn® heated controlled servo sensor.

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2018-08-01
• Study Completion: 2019-01-01
• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-29
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• age>18 years
• patients scheduled for major abdominal surgery
• patients scheduled for general anesthesia
• expected surgery duration longer than 30 minutes

Exclusion Criteria

• skin infection in the forehead
• upper airway anatomy alterations
• pre-existing oesophageal disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical patients	temperature monitoring	Patients who were candidates for major or urological surgery under general anaesthesia will be observed. In particular, the core body temperature will be measured with both a single-use oesophageal probe and a SpotOn® heated controlled servo sensor.

Primary Outcome Measures

Name	Time	Method
accuracy of heated controlled servo sensor in monitoring body core temperature compared with oesophageal probe	1 hour after the induction of general anesthesia	Difference between temperature measured with heated controlled servo sensor and oesophageal probe

Trial Locations

Locations (1)

Azienda Ospedaliero Universitaria Careggi; 🇮🇹 Florence, Italy