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

NCT ID: NCT03820232

Last Updated: 2023-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-01-01

Brief Summary

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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

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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.

Conditions

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Surgery Temperature Change, Body

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

temperature monitoring

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Careggi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gianluca Villa

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gianluca Villa

Role: PRINCIPAL_INVESTIGATOR

Azienda Careggi

Locations

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Azienda Ospedaliero Universitaria Careggi

Florence, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 31673946 (View on PubMed)

Other Identifiers

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11994_spe

Identifier Type: -

Identifier Source: org_study_id

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