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

NCT03820232 | Completed FDA Device

• 1 other identifier: 11994_spe
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Temperature Change, Body

Keywords

Intraoperative, Hypothermia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

temperature monitoring DEVICE

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

Surgical patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Careggi Hospital: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Careggi

Florence, 50100, Italy

Location

Related Publications (1)

• 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.

  PMID: 31673946 DERIVED

MeSH Terms

Conditions

Body Temperature Changes; Hypothermia

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gianluca Villa

  Azienda Careggi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: January 29, 2019
• Study Start: March 1, 2018
• Primary Completion: August 1, 2018
• Study Completion: January 1, 2019
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)