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Completed

NCT Number: NCT03820232

Intraoperative Body Core Temperature Monitoring: Oesophageal Probe vs 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.

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Key information

Conditions

Surgery Body Temperature Changes Hypothermia Pathological Conditions, Signs and Symptoms Signs and Symptoms Temperature Change, Body

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliero Universitaria Careggi

Florence, 50100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. accuracy of heated controlled servo sensor in monitoring body core temperature compared with oesophageal probe

    Time frame: 1 hour after the induction of general anesthesia

    Difference between temperature measured with heated controlled servo sensor and oesophageal probe

Sponsors and collaborators

Lead sponsor

Careggi Hospital

Other

Registry information

Official study title

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

Acronym: ESOSPOT

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jan 29, 2019
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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