Evaluation of the Reliability of Oesophageal Temperature in THOracic Surgery

NCT03903991 | Completed

• 2 other identifiers: RIPH3-RNI18-ThoTem2019-A00407-50
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypothermia; Thoracic Neoplasm; Anesthesia

Keywords

Thoracic surgery; Body temperature

Outcome Measures

Primary Outcomes (1)

• Correlation between tympanic and oesophageal temperature.

  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.

  up to 1 day (during the surgery)

Secondary Outcomes (1)

• Difference of correlation between tympanic and oesophageal temperature during left and right thoracotomy.

  up to 1day (during the surgery)

Study Arms (1)

Thoracotomy

All patients needing pulmonary surgery under thoracotomy

Other: Temperature recording

Interventions

Temperature recording OTHER

Tympanic and oesophageal temperatures will be recorded during the procedure

Thoracotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• all patients needing pulmonary surgery under thoracotomy

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (2)

Department of Anesthesiology - Surgical Intensive Care, University Hospital, Nîmes

Nîmes, 300029, France

Location

Department of Anesthesiology - Surgical Intensive Care II, University Hospital, Tours

Tours, 37044, France

Location

Related Publications (12)

• Sessler DI. Perioperative thermoregulation and heat balance. Lancet. 2016 Jun 25;387(10038):2655-2664. doi: 10.1016/S0140-6736(15)00981-2. Epub 2016 Jan 8.

  PMID: 26775126 BACKGROUND

• Rajagopalan S, Mascha E, Na J, Sessler DI. The effects of mild perioperative hypothermia on blood loss and transfusion requirement. Anesthesiology. 2008 Jan;108(1):71-7. doi: 10.1097/01.anes.0000296719.73450.52.

  PMID: 18156884 BACKGROUND

• Kurz A, Sessler DI, Lenhardt R. Perioperative normothermia to reduce the incidence of surgical-wound infection and shorten hospitalization. Study of Wound Infection and Temperature Group. N Engl J Med. 1996 May 9;334(19):1209-15. doi: 10.1056/NEJM199605093341901.

  PMID: 8606715 BACKGROUND

• Melling AC, Ali B, Scott EM, Leaper DJ. Effects of preoperative warming on the incidence of wound infection after clean surgery: a randomised controlled trial. Lancet. 2001 Sep 15;358(9285):876-80. doi: 10.1016/S0140-6736(01)06071-8.

  PMID: 11567703 BACKGROUND

• Frank SM, Fleisher LA, Breslow MJ, Higgins MS, Olson KF, Kelly S, Beattie C. Perioperative maintenance of normothermia reduces the incidence of morbid cardiac events. A randomized clinical trial. JAMA. 1997 Apr 9;277(14):1127-34.

  PMID: 9087467 BACKGROUND

• Winkler M, Akca O, Birkenberg B, Hetz H, Scheck T, Arkilic CF, Kabon B, Marker E, Grubl A, Czepan R, Greher M, Goll V, Gottsauner-Wolf F, Kurz A, Sessler DI. Aggressive warming reduces blood loss during hip arthroplasty. Anesth Analg. 2000 Oct;91(4):978-84. doi: 10.1097/00000539-200010000-00039.

  PMID: 11004060 BACKGROUND

• Scott AV, Stonemetz JL, Wasey JO, Johnson DJ, Rivers RJ, Koch CG, Frank SM. Compliance with Surgical Care Improvement Project for Body Temperature Management (SCIP Inf-10) Is Associated with Improved Clinical Outcomes. Anesthesiology. 2015 Jul;123(1):116-25. doi: 10.1097/ALN.0000000000000681.

  PMID: 25909970 BACKGROUND

• Niven DJ, Gaudet JE, Laupland KB, Mrklas KJ, Roberts DJ, Stelfox HT. Accuracy of peripheral thermometers for estimating temperature: a systematic review and meta-analysis. Ann Intern Med. 2015 Nov 17;163(10):768-77. doi: 10.7326/M15-1150.

  PMID: 26571241 BACKGROUND

• Robinson J, Charlton J, Seal R, Spady D, Joffres MR. Oesophageal, rectal, axillary, tympanic and pulmonary artery temperatures during cardiac surgery. Can J Anaesth. 1998 Apr;45(4):317-23. doi: 10.1007/BF03012021.

  PMID: 9597204 BACKGROUND

• Gobolos L, Philipp A, Ugocsai P, Foltan M, Thrum A, Miskolczi S, Pousios D, Khawaja S, Budra M, Ohri SK. Reliability of different body temperature measurement sites during aortic surgery. Perfusion. 2014 Jan;29(1):75-81. doi: 10.1177/0267659113497228. Epub 2013 Jul 17.

  PMID: 23863492 BACKGROUND

• Rau B, Hunerbein M, Barth C, Schlag PM. [Thoracoscopy is a reliable alternative to thoracotomy in peripheral lung coin lesion]. Langenbecks Arch Chir Suppl Kongressbd. 1997;114:1280-2. German.

  PMID: 9574403 BACKGROUND

• Mekjavic IB, Rempel ME. Determination of esophageal probe insertion length based on standing and sitting height. J Appl Physiol (1985). 1990 Jul;69(1):376-9. doi: 10.1152/jappl.1990.69.1.376.

  PMID: 2394660 BACKGROUND

MeSH Terms

Conditions

Hypothermia; Thoracic Neoplasms

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms

Study Officials

• Francis REMERAND, MD-PHD

  CHU Tours

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 4, 2019
• Study Start: July 18, 2019
• Primary Completion: May 25, 2020
• Study Completion: May 25, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

FR (2)