Hypothermia, PerioperativeHYPOTHERMIENCT02790086
Prevalence Survey in France of Unintentional Perioperative Hypothermia and Its Impact on Two Outcomes
An observational study of Hypothermia, Perioperative, run by Société Française d'Anesthésie et de Réanimation at 1 site in France.
Trial summary
The primary objectives of the study are to perform a survey on the clinical management of unintentional hypothermia during surgery in France. to assess the impact of perioperative hypothermia on anemia and myocardial injury. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Hypothermia, Perioperative
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Oct 2016
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing surgical intervention, requiring 2 days of hospitalization
Who may be able to join
- Non-ambulatory surgery.
- Duration of anesthesia > 30 minutes.
- Type of surgery: urology, gynecological, gastrointestinal, vascular and orthopedics surgery.
- Type of anesthesia: general, intrathecal or epidural anesthesia.
- patient ≥ 45 years.
- No opposition of patient to participate in the study.
Who cannot join
- Emergency surgery.
- Cardiac surgery, proctology surgery or thoracic surgery.
- Digestive endoscopy or surgical radiology.
- Septic surgery.
- Patient with at least one organ failure.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'Anesthésie-Réanimation Chirurgicale, Hôpital Cochin
Paris, Île-de-France Region, 75014
Pascal ALFONSI, MD, + 33 1 58 41 41 41, pascal.alfonsi@apr.aphp.fr
About this study
Official title: Prevalence Survey in France of Unintentional Perioperative Hypothermia and Its Impact on Two Outcomes: Blood Loss, Myocardial Injury After Non Cardiac Surgery
The primary objectives of the study are
- to perform a survey on the clinical management of unintentional hypothermia during surgery in France.
- to assess the impact of perioperative hypothermia on anemia and myocardial injury.
Read the detailed description
100 investigation centers in metropolitan France will participate in the study, targeting 2000 included patients (20 surgical interventions in each center). The duration of inclusion in each center should last at most 2 weeks.
The selected surgical interventions will be those performed with a high frequency, practiced in all types of hospitals (public, private, university hospital or not), and requiring anesthesia of at leat 30 minutes (general, epidural or intrathecal anesthesia).
- Conditions
- Hypothermia, Perioperative
- Keywords
- hypothermia, prevalence, perioperative, anemia, myocardial injury, troponin T, noncardiac surgery
- Medical subject headings
- Hypothermia, Anemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Core temperature
The temperature will be measured with the same type of thermometer in all investigator sites: SpotOn™ (3M France).
Measured: up to 24 hours
blood loss
Blood loss will be assessed by haemoglobin variation between preoperative and the first post-operative day.
Measured: up to 24 hours
myocardial injury
Troponin T will be measured after the surgical intervention (at least 6 hours after the end of the surgery) and on the second postoperative day (when the patient remains hospitalized).
Measured: up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startOct 2014
- Primary completionJul 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothermia, PerioperativeStudies of the same condition, open and under way.
- 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société Française d'Anesthésie et de Réanimation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal ALFONSI, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790086
- Sponsor's protocol ID
- 13-HYPOTHERMIE
- Acronym
- HYPOTHERMIE
- Status last verified
- May 2016
- First submitted
- 4 May 2016
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence Survey in France of Unintentional Perioperative Hypothermia and Its Impact on Two Outcomes: Blood Loss, Myocardial Injury After Non Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02790086
- Acronym / sponsor ID
- HYPOTHERMIE / 13-HYPOTHERMIE
- Conditions
- Hypothermia, Perioperative
- Keywords
- hypothermia, prevalence, perioperative, anemia, myocardial injury, troponin T, noncardiac surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Société Française d'Anesthésie et de RéanimationUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 3 Jun 2016 (estimated)
- 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.
The primary objectives of the study are
- to perform a survey on the clinical management of unintentional hypothermia during surgery in France.
- to assess the impact of perioperative hypothermia on anemia and myocardial injury.
Detailed description
100 investigation centers in metropolitan France will participate in the study, targeting 2000 included patients (20 surgical interventions in each center). The duration of inclusion in each center should last at most 2 weeks.
The selected surgical interventions will be those performed with a high frequency, practiced in all types of hospitals (public, private, university hospital or not), and requiring anesthesia of at leat 30 minutes (general, epidural or intrathecal anesthesia).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgical intervention, requiring 2 days of hospitalization
Key inclusion criteria (6 listed)
- Non-ambulatory surgery.
- Duration of anesthesia > 30 minutes.
- Type of surgery: urology, gynecological, gastrointestinal, vascular and orthopedics surgery.
- Type of anesthesia: general, intrathecal or epidural anesthesia.
- patient ≥ 45 years.
Key exclusion criteria (5 listed)
- Emergency surgery.
- Cardiac surgery, proctology surgery or thoracic surgery.
- Digestive endoscopy or surgical radiology.
- Septic surgery.
- Patient with at least one organ failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Core temperature
Time frame: up to 24 hours
The temperature will be measured with the same type of thermometer in all investigator sites: SpotOn™ (3M France).
blood loss
Time frame: up to 24 hours
Blood loss will be assessed by haemoglobin variation between preoperative and the first post-operative day.
myocardial injury
Time frame: up to 48 hours
Troponin T will be measured after the surgical intervention (at least 6 hours after the end of the surgery) and on the second postoperative day (when the patient remains hospitalized).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
- 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.
Pascal ALFONSI, MD principal investigator
Assistance Publique - Hôpitaux de Paris
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, Perioperative, run by Société Française d'Anesthésie et de Réanimation 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Jun 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pascal ALFONSI, MD (+ 33 1 58 41 41 41, pascal.alfonsi@apr.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core temperature (time frame: up to 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2016.