ThoTem: Evaluation of the Reliability of Oesophageal Temperature in THOracic Surgery

Sponsor
University Hospital, Tours (Other)
Overall Status
Completed
CT.gov ID
NCT03903991
Collaborator
(none)
51
2
10.3
25.5
2.5

Study Details

Study Description

Brief Summary

Controlling hypothermia is essential in anesthesia to limit postoperative complications. Temperature monitoring is therefore essential. However, the reliability of esophageal temperature during open chest lung surgery is discussed and not accurately assessed in the literature.

Condition or Disease Intervention/Treatment Phase
  • Other: Temperature recording

Detailed Description

Controlling hypothermia is essential in anesthesia to limit postoperative complications. Temperature monitoring is therefore essential. However, the reliability of esophageal temperature during open chest lung surgery is discussed and not accurately assessed in the literature.

The investigators therefore decided to evaluate the reliability of the oesophageal temperature in open chest lung surgery by comparing it to the continuous tympanic temperature.

Study Design

Study Type:
Observational
Actual Enrollment :
51 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of the Reliability of Oesophageal Temperature in THOracic Surgery
Actual Study Start Date :
Jul 18, 2019
Actual Primary Completion Date :
May 25, 2020
Actual Study Completion Date :
May 25, 2020

Arms and Interventions

Arm Intervention/Treatment
Thoracotomy

All patients needing pulmonary surgery under thoracotomy

Other: Temperature recording
Tympanic and oesophageal temperatures will be recorded during the procedure

Outcome Measures

Primary Outcome Measures

  1. Correlation between tympanic and oesophageal temperature. [up to 1 day (during the surgery)]

    Evaluate the correlation existing between the tympanic temperature, reflection of the central temperature without variation with an open thorax, and oesophageal temperature subject to changes.

Secondary Outcome Measures

  1. Difference of correlation between tympanic and oesophageal temperature during left and right thoracotomy. [up to 1day (during the surgery)]

    Evaluate the correlation existing between the tympanic temperature, reflection of the central temperature without variation with an open thorax, and oesophageal temperature subject to changes.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • all patients needing pulmonary surgery under thoracotomy
Exclusion Criteria:
  • patient refusal

  • esophageal or otological pathology preventing the installation of thermal probes

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Anesthesiology - Surgical Intensive Care, University Hospital, Nîmes Nîmes France 300029
2 Department of Anesthesiology - Surgical Intensive Care II, University Hospital, Tours Tours France 37044

Sponsors and Collaborators

  • University Hospital, Tours

Investigators

  • Study Director: Francis REMERAND, MD-PHD, CHU Tours

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT03903991
Other Study ID Numbers:
  • RIPH3-RNI18-ThoTem
  • 2019-A00407-50
First Posted:
Apr 4, 2019
Last Update Posted:
Apr 28, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Tours
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 28, 2021