HypothermiaThoTemNCT03903991
Evaluation of the Reliability of Oesophageal Temperature in THOracic Surgery
An observational study of Hypothermia and Thoracic Neoplasm, run by University Hospital, Tours at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypothermia, Thoracic Neoplasm, Anesthesia
- What is being tested?
- Temperature recording
- How many people
- 51 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Jul 2019to 25 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adults inpatients with thoracotomy surgery, in our University hospital in France
Who may be able to join
- all patients needing pulmonary surgery under thoracotomy
Who cannot join
- patient refusal
- esophageal or otological pathology preventing the installation of thermal probes
Trial locations and contacts
2 sites in 1 country.
France2 sites
Department of Anesthesiology - Surgical Intensive Care, University Hospital, Nîmes
Nîmes, 300029
Department of Anesthesiology - Surgical Intensive Care II, University Hospital, Tours
Tours, 37044
About this study
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.
Read the 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.
- Conditions
- Hypothermia, Thoracic Neoplasm, Anesthesia
- Being tested
- Temperature recording
- Keywords
- Thoracic surgery, Body temperature
- Medical subject headings
- Hypothermia, Thoracic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temperature recordingOther
Tympanic and oesophageal temperatures will be recorded during the procedure
| Study group | Role | What they receive |
|---|---|---|
| Thoracotomy | All patients needing pulmonary surgery under thoracotomy Receives: Other: Temperature recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 1 day (during the surgery)
Secondary outcomes (1)
Difference of correlation between tympanic and oesophageal temperature during left and right thoracotomy.
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.
Measured: up to 1day (during the surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start18 Jul 2019
- Primary completion25 May 2020
- Study completion25 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis REMERAND, MD-PHD, Study director, CHU Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903991
- Sponsor's protocol ID
- RIPH3-RNI18-ThoTem
- Other IDs
- 2019-A00407-50
- Acronym
- ThoTem
- Status last verified
- Apr 2021
- First submitted
- 1 Apr 2019
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26775126Rajagopalan 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.
PubMed 18156884Kurz 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.
PubMed 8606715Melling 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.
PubMed 11567703Frank 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.
PubMed 9087467Winkler 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.
PubMed 11004060Scott 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.
PubMed 25909970Niven 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.
PubMed 26571241Robinson 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.
PubMed 9597204Gobolos 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.
PubMed 23863492Rau 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.
PubMed 9574403Mekjavic 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.
PubMed 2394660
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Reliability of Oesophageal Temperature in THOracic Surgery
- ClinicalTrials.gov ID
- NCT03903991
- Acronym / sponsor ID
- ThoTem / RIPH3-RNI18-ThoTem
- Conditions
- Hypothermia, Thoracic Neoplasm, Anesthesia
- Keywords
- Thoracic surgery, Body temperature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 18 Jul 2019 (actual)
- Primary completion
- 25 May 2020 (actual)
- Study completion
- 25 May 2020 (actual)
- First posted
- 4 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thoracotomy | – | Other: Temperature recordingAll patients needing pulmonary surgery under thoracotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults inpatients with thoracotomy surgery, in our University hospital in France
Key inclusion criteria (1 listed)
- all patients needing pulmonary surgery under thoracotomy
Key exclusion criteria (2 listed)
- patient refusal
- esophageal or otological pathology preventing the installation of thermal probes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temperature recordingTympanic and oesophageal temperatures will be recorded during the procedure | Other | Thoracotomy |
Primary outcome
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.
1 secondary outcome
Difference of correlation between tympanic and oesophageal temperature during left and right thoracotomy.
Time frame: up to 1day (during the surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Background: PubMed 26775126Sessler 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.
- Background: PubMed 18156884Rajagopalan 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.
- Background: PubMed 8606715Kurz 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.
- Background: PubMed 11567703Melling 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.
- Background: PubMed 9087467Frank 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.
- Background: PubMed 11004060Winkler 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.
- Background: PubMed 25909970Scott 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.
- Background: PubMed 26571241Niven 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.
- Background: PubMed 9597204Robinson 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.
- Background: PubMed 23863492Gobolos 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.
- Background: PubMed 9574403Rau 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.
- Background: PubMed 2394660Mekjavic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis REMERAND, MD-PHD study director
CHU Tours
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothermia and Thoracic Neoplasm, run by University Hospital, Tours at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between tympanic and oesophageal temperature. (time frame: up to 1 day (during the surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03903991, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.