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

Surgery Clinical Trial

— ESOSPOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03820232
• Other study ID #: 11994_spe
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: August 2023
• Source: Careggi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 1, 2019
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Temperature Changes
• Surgery
• Temperature Change, Body

Intervention

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

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Careggi	Florence

Sponsors (1)

Lead Sponsor	Collaborator
Careggi Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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