HypothermiaROTHYNCT04935632
Perioperative Collection of Temperatures and Hypothermia
An observational study of Hypothermia and Hypothermia; Anesthesia, run by Centre Leon Berard at 1 site in France.
Trial summary
Accidental perioperative hypothermia is a frequent complication of anesthesia that favors the occurrence of infections, bleeding and perioperative cardiovascular accidents, and is responsible for perioperative excess mortality. Although preventive measures are widely used, it remains very frequent in France. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypothermia, Hypothermia; Anesthesia, Hypothermia, Accidental
- What is being tested?
- prevention training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 388 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jun 2021to 31 Jul 2022
- 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: patients operated on at the Léon Bérard Centre, whether for scheduled, emergency or outpatient surgery
Who may be able to join
- >= 18 years old
- surgeries performed at the Centre Léon Bérard
Who cannot join
- Digestive endoscopy, interventional radiology, brachytherapy (operating rooms outside the central operating room)
- Patient who decline to participate in the study
- Active systemic infection
- Hyperthermic Intraperitoneal Chemotherapy (HIPEC) or Intrathoracic Chemotherapy (HITeC)
- Deprivation of liberty
- operation performed under local anesthesia only
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Collection of Temperatures and Hypothermia (Recueil périOpératoire Des Températures et de l'Hypothermie - ROTHY)
Accidental perioperative hypothermia is a frequent complication of anesthesia that favors the occurrence of infections, bleeding and perioperative cardiovascular accidents, and is responsible for perioperative excess mortality. Although preventive measures are widely used, it remains very frequent in France. This observation led a group of experts to draft, under the aegis of the Société Française d'Anesthésie et de Réanimation (SFAR), several recommendations aimed at improving the prevention of perioperative accidental hypothermia.
Perioperative hypothermia is defined as a core body temperature below 36.0 ° Celsius.
This study aims to evaluate the impact of hypothermia prevention training on the proportion of hypothermic patients in the operating room.
- Being tested
- prevention training
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prevention trainingBehavioural
Evaluate the impact of hypothermia prevention training on the proportion of patients hypothermic patients in the operating room
| Study group | Role | What they receive |
|---|---|---|
| Before implementation | Prior to the implementation of the measures resulting from the SFAR recommendations on the prevention of accidental perioperative hypothermia | |
| After implementation | After implementation of the measures resulting from the SFAR recommendations on the prevention of accidental perioperative hypothermia Receives: Behavioral: prevention training | |
| at a distance from the implementation | Approximately 8 months after implementation of the measures resulting from the SFAR recommendations on the prevention of accidental perioperative hypothermia. Receives: Behavioral: prevention training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intraoperative hypothermia
From the time of entry into the operating room to the time of exit from the operating room. Hypothermia is defined as a core body temperature below 36°Celsius (presence or absence).
Measured: Up to 24 hours
Secondary outcomes (3)
Incidence of hypothermia in the post-anesthesia care unit (PACU)
From the time of entry into the PACU, hypothermia is defined as a core body temperature below 36°Celsius (presence or absence).
Measured: Up to 24 hours
Tympanic temperature in the post-anaesthesia care unit (PACU)
From the time of entry into the PACU to the time of exit from the PACU.
Measured: Up to 24 hours
Intraoperative tympanic temperature
From the time of entry into the operating room to the time of exit from the operating room.
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start21 Jun 2021
- Primary completion30 Jun 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935632
- Sponsor's protocol ID
- ROTHY
- Acronym
- ROTHY
- Status last verified
- Feb 2023
- First submitted
- 11 Jun 2021
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sari S, Aksoy SM, But A. The incidence of inadvertent perioperative hypothermia in patients undergoing general anesthesia and an examination of risk factors. Int J Clin Pract. 2021 Jun;75(6):e14103. doi: 10.1111/ijcp.14103. Epub 2021 Feb 28.
PubMed 33616248
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Collection of Temperatures and Hypothermia (Recueil périOpératoire Des Températures et de l'Hypothermie - ROTHY)
- ClinicalTrials.gov ID
- NCT04935632
- Acronym / sponsor ID
- ROTHY / ROTHY
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 23 Jun 2021 (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.
Accidental perioperative hypothermia is a frequent complication of anesthesia that favors the occurrence of infections, bleeding and perioperative cardiovascular accidents, and is responsible for perioperative excess mortality. Although preventive measures are widely used, it remains very frequent in France. This observation led a group of experts to draft, under the aegis of the Société Française d'Anesthésie et de Réanimation (SFAR), several recommendations aimed at improving the prevention of perioperative accidental hypothermia.
Perioperative hypothermia is defined as a core body temperature below 36.0 ° Celsius.
This study aims to evaluate the impact of hypothermia prevention training on the proportion of hypothermic patients in the operating room.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Before implementation | – | –Prior to the implementation of the measures resulting from the SFAR recommendations on the prevention of accidental perioperative hypothermia |
| After implementation | – | Behavioral: prevention trainingAfter implementation of the measures resulting from the SFAR recommendations on the prevention of accidental perioperative hypothermia |
| at a distance from the implementation | – | Behavioral: prevention trainingApproximately 8 months after implementation of the measures resulting from the SFAR recommendations on the prevention of accidental perioperative hypothermia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients operated on at the Léon Bérard Centre, whether for scheduled, emergency or outpatient surgery
Key inclusion criteria (2 listed)
- >= 18 years old
- surgeries performed at the Centre Léon Bérard
Key exclusion criteria (6 listed)
- Digestive endoscopy, interventional radiology, brachytherapy (operating rooms outside the central operating room)
- Patient who decline to participate in the study
- Active systemic infection
- Hyperthermic Intraperitoneal Chemotherapy (HIPEC) or Intrathoracic Chemotherapy (HITeC)
- Deprivation of liberty
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 |
|---|---|---|
| prevention trainingEvaluate the impact of hypothermia prevention training on the proportion of patients hypothermic patients in the operating room | Behavioural | After implementation, at a distance from the implementation |
Primary outcome
Incidence of intraoperative hypothermia
Time frame: Up to 24 hours
From the time of entry into the operating room to the time of exit from the operating room. Hypothermia is defined as a core body temperature below 36°Celsius (presence or absence).
3 secondary outcomes
Incidence of hypothermia in the post-anesthesia care unit (PACU)
Time frame: Up to 24 hours
Tympanic temperature in the post-anaesthesia care unit (PACU)
Time frame: Up to 24 hours
Intraoperative tympanic temperature
Time frame: Up to 24 hours
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 Feb 2023.
- Background: PubMed 33616248Sari S, Aksoy SM, But A. The incidence of inadvertent perioperative hypothermia in patients undergoing general anesthesia and an examination of risk factors. Int J Clin Pract. 2021 Jun;75(6):e14103. doi: 10.1111/ijcp.14103. Epub 2021 Feb 28.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Hypothermia; Anesthesia, run by Centre Leon Berard at 1 site 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 2 inclusion and 6 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 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Incidence of intraoperative hypothermia (time frame: Up to 24 hours). 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 NCT04935632, which also lists 1 linked publication.
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 Feb 2023.