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Evaluation of the Reliability of Oesophageal Temperature in THOracic Surgery (ThoTem)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03903991
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

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
Hypothermia Thoracic Neoplasm Anesthesia 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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Reliability of Oesophageal Temperature in THOracic Surgery
Actual Study Start Date : July 18, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Group/Cohort Intervention/treatment
Thoracotomy
All patients needing pulmonary surgery under thoracotomy
Other: Temperature recording
Tympanic and oesophageal temperatures will be recorded during the procedure




Primary Outcome Measures :
  1. Correlation between tympanic and oesophageal temperature. [ Time Frame: 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. [ Time Frame: 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.



Information from the National Library of Medicine

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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
All adults inpatients with thoracotomy surgery, in our University hospital in France
Criteria

Inclusion Criteria:

  • all patients needing pulmonary surgery under thoracotomy

Exclusion Criteria:

  • patient refusal
  • esophageal or otological pathology preventing the installation of thermal probes

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): NCT03903991


Contacts
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Contact: Mikael PERIN, MD +33247478551 mikael.perin@chu-nimes.fr
Contact: Lea PASCOT lea.pascot@orange.fr

Locations
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France
Department of Anesthesiology - Surgical Intensive Care, University Hospital, Nîmes Not yet recruiting
Nîmes, France, 300029
Contact: Mikael PERIN, MD         
Principal Investigator: Mikael PERIN, MD         
Department of Anesthesiology - Surgical Intensive Care II, University Hospital, Tours Recruiting
Tours, France, 37044
Contact: Léa PASCOT         
Principal Investigator: Francis REMERAND, MD-PhD         
Sponsors and Collaborators
University Hospital, Tours
Investigators
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Study Director: Francis REMERAND, MD-PHD CHU Tours
Publications:

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Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT03903991    
Other Study ID Numbers: RIPH3-RNI18-ThoTem
2019-A00407-50 ( Other Identifier: IdRCB )
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Tours:
Thoracic surgery
Body temperature
Additional relevant MeSH terms:
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Thoracic Neoplasms
Hypothermia
Body Temperature Changes
Neoplasms by Site
Neoplasms