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

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ClinicalTrials.gov Identifier: NCT03820232
Recruitment Status : Completed
First Posted : January 29, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Gianluca Villa, Careggi Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Surgery Temperature Change, Body Device: temperature monitoring

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.
Study Design
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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intraoperative Body Core Temperature Monitoring in Patients Undergoing Major Abdominal Surgery: Comparison Between the Oesophageal Probe and the Heated Controlled Servo Sensor
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : January 1, 2019
Groups and Cohorts
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Group/Cohort Intervention/treatment
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
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


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820232


Locations
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Italy
Azienda Ospedaliero Universitaria Careggi
Florence, Italy, 50100
Sponsors and Collaborators
Careggi Hospital
Investigators
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Principal Investigator: Gianluca Villa Azienda Careggi
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gianluca Villa, Principal investigator, Careggi Hospital
ClinicalTrials.gov Identifier: NCT03820232    
Other Study ID Numbers: 11994_spe
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Gianluca Villa, Careggi Hospital:
Intraoperative, Hypothermia
Additional relevant MeSH terms:
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Body Temperature Changes