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CompletedNCT03820232ESOSPOTUpdated Aug 30, 2023

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

An observational study in Surgery and Temperature Change, Body, sponsored by Careggi Hospital. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-30.

Sponsored by Careggi Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Surgery
  • Temperature Change, Body

Keywords

  • Intraoperative, Hypothermia
03

In context

Body Temperature Changes

97 studies on the registry are indexed under Body Temperature Changes; 20 are open to participants now.

This study's enrollment of 100 is above the median of 87 across 24 observational studies indexed under Body Temperature Changes.

Browse Body Temperature Changes studies →

Lead sponsor

Careggi Hospital is the lead sponsor of 18 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • skin infection in the forehead
  • upper airway anatomy alterations
  • pre-existing oesophageal disease
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Devicetemperature 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

06

What researchers measure

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

    Time frame: 1 hour after the induction of general anesthesia

07

Study locations

1 site
  • Azienda Ospedaliero Universitaria Careggi
    Florence, 50100, Italy
08

References and documents

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. PubMed 31673946 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in Aug 2018, 5 months.

Of 16 observational studies under Body Temperature Changes, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 45. This study's 5 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 25, 2019
First posted
Jan 29, 2019
StartActual
Mar 1, 2018
Primary completionActual
Aug 1, 2018
CompletionActual
Jan 1, 2019
Last update
Aug 30, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03820232
Lead sponsor
Careggi Hospital
Responsible party
Gianluca Villa (Principal investigator, Careggi Hospital) — Principal investigator
First posted
Jan 29, 2019
Start date
Mar 1, 2018
Primary completion
Aug 1, 2018
Completion
Jan 1, 2019
Last update
Aug 30, 2023

Study contacts

Gianluca Villa
principal investigator · Azienda Careggi

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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