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

Intraoperative Body Core Temperature Monitoring in Patients Undergoing Major Abdominal Surgery: Comparison Between the Oesophageal Probe and the Heated Controlled Servo Sensor

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Temperature Change, Body
• Intervention / Treatment: Device: temperature monitoring

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Italy
  • Florence, Italy, 50100
    • Azienda Ospedaliero Universitaria Careggi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who were candidates for major or urological surgery were considered eligible to be enrolled. The core body temperature was measured with both a single-use oesophageal probe and a SpotOn® heated controlled servo sensor.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgical patients; 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.	Device: temperature monitoring; In every patient observed in this prospective observational study, body core temperature will be contemporaneously monitored through the oesophageal probe and the heated controlled servo sensor. Both are routinely used for this purpose in clinical practice

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Careggi Hospital
• Investigators: Principal Investigator: Gianluca Villa, Azienda Careggi

Publications and helpful links

General Publications

• Morettini E, Turchini F, Tofani L, Villa G, Ricci Z, Romagnoli S. Intraoperative core temperature monitoring: accuracy and precision of zero-heat flux heated controlled servo sensor compared with esophageal temperature during major surgery; the ESOSPOT study. J Clin Monit Comput. 2020 Oct;34(5):1111-1119. doi: 10.1007/s10877-019-00410-z. Epub 2019 Oct 31.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: January 25, 2019
• First Posted (Actual): January 29, 2019

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Intraoperative, Hypothermia
• Additional Relevant MeSH Terms: Body Temperature Changes
• Other Study ID Numbers: 11994_spe

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No