Hypothermia; AnesthesiaREGLONCT06551558
Impact of a Global Warming Strategy of the Patient on the Prevalence of Hypothermia in the Recovering Room
A study testing global warming and per operative warming in people with Hypothermia; Anesthesia and Perioperative/Postoperative Complications, run by Poitiers University Hospital at 1 site in France.
Trial summary
50% of patients are hypothermic when they arrive in the recovery room. This hypothermia is potentially at risk for the patient (increases bleeding, risk of infection, risk of cardiac involvement, morbid mortality) and 33,2% steel hypothermic when they discharge from the recovering room. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypothermia; Anesthesia, Perioperative/Postoperative Complications
- What is being tested?
- global warming and per operative warming
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteFrance
- Study dates
- 8 Nov 2024to 23 Sep 2026
- Phase
- Interventional
- 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
Who may be able to join
- Patient undergoing laparoscopic visceral surgery under general anesthesia with transition to recovering room
Who cannot join
- Patient undergoing urgent surgery.
- Presence of pre-existing infection (temperature higher than 38°C when receiving the patient in the hospital ward.
- Patient with predetermined length of stay in recovering room.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Global Warming Strategy, From the Patient Arrival in the Operating Room to His Discharge From the Recovering Room, Versus a Recommended Management of Intraoperative Warming on the Prevalence of Hypothermia in the Recovering Room
50% of patients are hypothermic when they arrive in the recovery room. This hypothermia is potentially at risk for the patient (increases bleeding, risk of infection, risk of cardiac involvement, morbid mortality) and 33,2% steel hypothermic when they discharge from the recovering room. The anesthesia team must prevent these risks through prevention and treatment measures. Currently the majority of patient warming is done only in the operating room, we want to measure the impact of the extension of this warming before and after the surgery on the patient's temperature and on side effects related to hypothermia.
Read the detailed description
Hypothermia is defined as a core temperature below 36°C. It is classified by severity stage. A temperature below 36°C is mild hypothermia, below 35°C moderate hypothermia and below 34°C severe hypothermia.
The impact of hypothermia on the body is related to decreased metabolic and immune activities. The vasoconstriction induced by hypothermia implies a decrease in vascularization of the organs that can cause tissue damage.
These effects explain the role of hypothermia in the pathophysiology of certain perioperative and postoperative complications in the longer term.
Intraoperative hypothermia is responsible for the increase of:
- 4 times the risk of Surgical Site Infection,
- twice the risk of cardiovascular morbidity, associated with increased mortality,
- 33% of transfusion need,
- 1.5 times the need for continued mechanical ventilation,
- 3 times the duration of recovering room,
- twice the hospital stay. This is why hypothermia is responsible for excess perioperative mortality.
According to a 2019 study (Alfonsi P, Bekka S, Aegerter P, SFAR Research Network investigators. Prevalence of hypothermia on admission to recovery room remains high despite a large use of forced-air warming devices: Findings of a non-randomized observational multicenter and pragmatic study on perioperative hypothermia prevalence in France), the prevalence of hypothermia increases from 16.2% of patients before anesthetic induction to 53.5% of patients admitted to the Recovering room. At the end of Recovering room, 33.2% of patients were hypothermic. Among these patients, 15.2% became hypothermic during the recovering room stay.
The risk factors for perioperative hypothermia are multiple:
Patient-related factors: low body mass index; undernutrition; ASA score > 1; pre-existing conditions altering thermoregulation (ex: diabetes with polyneuropathy, hypothyroidism, consumption of sedative or psychoactive drugs); pre-existing hypothermia at surgery.
Factors related to anesthesia techniques: duration of anesthesia > 2 hours; combined general and neuro-axial anesthesia; administration of large volumes of intravenous solutes or transfusion of non-rewarmed globular units.
Factors related to surgery: type, extent and duration of surgery witch use of large amounts of unheated irrigation fluid.
- Being tested
- global warming, per operative warming
- Medical subject headings
- Hypothermia, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
global warmingOther
A systematic pre- and post-operative warming associated with the optimization of per-operative warming.
per operative warmingOther
per-operative warming only thanks to the "Optimized" Forced air blanket with a prewarming of 10 minutes performed in the operating room.
| Study group | Role | What they receive |
|---|---|---|
| RéGlo arm | Experimental | Innovative support with global warming strategy. Receives: Other: global warming |
| Control arm | Other | Support according to recommendations Receives: Other: per operative warming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, the prevalence of hypothermia at the exit of Interventional for patients who underwent laparoscopic visceral surgery.
Proportion of patients with hypothermia after discharge of recovering room. Hypothermia is defined as a body temperature < 36°C.
Measured: 1 day
Secondary outcomes (20)
Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, the average total mechanical ventilation time
it is the time between intubation and extubation, expressed in minutes.
Measured: 1 day
Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, the average thermal comfort of preoperative patients, on arrival in the pre- anesthesia room
evaluated by the Likert scale, ranging from 0 for discomfort too cold with strong chills to 4 for discomfort too hot with sweat with optimal comfort to 2 (self-assessment)
Measured: 1 day
Compare between the experimental group of global warming (RéGlo) and the control group of per- operative warming, the average thermal comfort of preoperative patients, on arrival in the recovering room
every 15minutes until discharge, evaluated by the Likert scale, ranging from 0 for discomfort too cold with strong chills to 4 for discomfort too hot with sweat with optimal comfort to 2 (self-assessment).
Measured: 1 day
Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, the proportion of patients in intraoperative hypothermia
number of patient with body temperature under 36°C between arrival in pre-operative room and discharge of operating room
Measured: 1 day
Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, The average time spent below 36°C (mild hypothermia)
expressed in minutes.
Measured: 1 day
Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, The average time spent below 35°C (moderate hypothermia)
expressed in minutes.
Measured: 1 day
Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, The average time spent below 34°C (severe hypothermia)
expressed in minutes.
Measured: 1 day
Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, The lowest average temperature reached in °C over the entire management
the lowest temperture between arrival in the pre-anaesthesia room and exit from recovering room
Measured: 1 day
Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, The proportion of hypothermic patients arriving in recovering room
number of patient with a temperature below 36°C
Measured: 1 day
Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, The average duration of oxygen therapy
calculated from the introduction of oxygen therapy until its withdrawal in post extubation, regardless of the time of implementation or cessation before resumption of treatment (failure to withdraw oxygen therapy will not be considered), expressed in minutes.
Measured: 1 day
Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, Post-intervention complications in recovering room, the average number of Nausea or Vomiting Postoperative
number of patient with Nausea or Vomiting in recovering room evaluated every 15 minutes until discharge
Measured: 1 day
Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, Post-intervention complications in recovering room, the average number of chills
number of chills during post-operative monitoring by a Likert scale
Measured: 1 day
Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, Post-intervention complications in recovering room, the average number of stirring phase presence
number of stirring phase evaluated every 15 minutes until discharge
Measured: 1 day
The average amount of blood loss per operation
blood loss measured from the time of entry into the operating theatre to the exit from the operating theatre expressed in millilitres.
Measured: 1 day
The average of immediate post-operative blood loss
blood loss measured in recovering room expressed in millilitres
Measured: 1 day
The general average of the thermal variation
the difference between the patient's lowest and highest temperature between their arrival in the pre-anaesthesia room and their exit from recovering room, expressed in degrees Celsius
Measured: 1 day
The average of thermal variation in pre operative
the difference between the lowest and highest temperature of the patient between the arrival in the waiting room of the operating room and the arrival in the operating room, expressed in degrees Celsius
Measured: 1 day
The average thermal variation in per operative
the difference between the lowest and highest temperature of the patient between the arrival and exit of the operating room, expressed in degrees Celsius
Measured: 1 day
the average thermal variation in post operative
the difference between the lowest and highest temperature of the patient between arrival in and validation exit criteria of recovering room,expressed in degrees Celsius
Measured: 1 day
The average length of stay in recovering room
difference between the time of arrival in recovering room and the time of obtaining the exit criteria , expressed in minutes.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start8 Nov 2024
- Primary completion23 Sep 2026
- Study completion23 Sep 2026
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 Hypothermia; AnesthesiaStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu Boisson, Pu-Ph, Principal investigator, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551558
- Sponsor's protocol ID
- 2023-A02502-43
- Acronym
- REGLO
- Status last verified
- Sep 2026
- First submitted
- 9 Aug 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alfonsi P, Bekka S, Aegerter P; SFAR Research Network investigators. Prevalence of hypothermia on admission to recovery room remains high despite a large use of forced-air warming devices: Findings of a non-randomized observational multicenter and pragmatic study on perioperative hypothermia prevalence in France. PLoS One. 2019 Dec 23;14(12):e0226038. doi: 10.1371/journal.pone.0226038. eCollection 2019.
PubMed 31869333
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Global Warming Strategy, From the Patient Arrival in the Operating Room to His Discharge From the Recovering Room, Versus a Recommended Management of Intraoperative Warming on the Prevalence of Hypothermia in the Recovering Room
- ClinicalTrials.gov ID
- NCT06551558
- Acronym / sponsor ID
- REGLO / 2023-A02502-43
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 23 Sep 2026 (actual)
- Study completion
- 23 Sep 2026 (actual)
- First posted
- 13 Aug 2024 (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.
50% of patients are hypothermic when they arrive in the recovery room. This hypothermia is potentially at risk for the patient (increases bleeding, risk of infection, risk of cardiac involvement, morbid mortality) and 33,2% steel hypothermic when they discharge from the recovering room. The anesthesia team must prevent these risks through prevention and treatment measures. Currently the majority of patient warming is done only in the operating room, we want to measure the impact of the extension of this warming before and after the surgery on the patient's temperature and on side effects related to hypothermia.
Detailed description
Hypothermia is defined as a core temperature below 36°C. It is classified by severity stage. A temperature below 36°C is mild hypothermia, below 35°C moderate hypothermia and below 34°C severe hypothermia.
The impact of hypothermia on the body is related to decreased metabolic and immune activities. The vasoconstriction induced by hypothermia implies a decrease in vascularization of the organs that can cause tissue damage.
These effects explain the role of hypothermia in the pathophysiology of certain perioperative and postoperative complications in the longer term.
Intraoperative hypothermia is responsible for the increase of:
- 4 times the risk of Surgical Site Infection,
- twice the risk of cardiovascular morbidity, associated with increased mortality,
- 33% of transfusion need,
- 1.5 times the need for continued mechanical ventilation,
- 3 times the duration of recovering room,
- twice the hospital stay. This is why hypothermia is responsible for excess perioperative mortality.
According to a 2019 study (Alfonsi P, Bekka S, Aegerter P, SFAR Research Network investigators. Prevalence of hypothermia on admission to recovery room remains high despite a large use of forced-air warming devices: Findings of a non-randomized observational multicenter and pragmatic study on perioperative hypothermia prevalence in France), the prevalence of hypothermia increases from 16.2% of patients before anesthetic induction to 53.5% of patients admitted to the Recovering room. At the end of Recovering room, 33.2% of patients were hypothermic. Among these patients, 15.2% became hypothermic during the recovering room stay.
The risk factors for perioperative hypothermia are multiple:
Patient-related factors: low body mass index; undernutrition; ASA score > 1; pre-existing conditions altering thermoregulation (ex: diabetes with polyneuropathy, hypothyroidism, consumption of sedative or psychoactive drugs); pre-existing hypothermia at surgery.
Factors related to anesthesia techniques: duration of anesthesia > 2 hours; combined general and neuro-axial anesthesia; administration of large volumes of intravenous solutes or transfusion of non-rewarmed globular units.
Factors related to surgery: type, extent and duration of surgery witch use of large amounts of unheated irrigation fluid.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RéGlo arm | Experimental | Other: global warmingInnovative support with global warming strategy. |
| Control arm | Other | Other: per operative warmingSupport according to recommendations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient undergoing laparoscopic visceral surgery under general anesthesia with transition to recovering room
Key exclusion criteria (3 listed)
- Patient undergoing urgent surgery.
- Presence of pre-existing infection (temperature higher than 38°C when receiving the patient in the hospital ward.
- Patient with predetermined length of stay in recovering room.
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 |
|---|---|---|
| global warmingA systematic pre- and post-operative warming associated with the optimization of per-operative warming. | Other | RéGlo arm |
| per operative warmingper-operative warming only thanks to the "Optimized" Forced air blanket with a prewarming of 10 minutes performed in the operating room. | Other | Control arm |
Primary outcome
Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, the prevalence of hypothermia at the exit of Interventional for patients who underwent laparoscopic visceral surgery.
Time frame: 1 day
Proportion of patients with hypothermia after discharge of recovering room. Hypothermia is defined as a body temperature < 36°C.
20 secondary outcomes
Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, the average total mechanical ventilation time
Time frame: 1 day
Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, the average thermal comfort of preoperative patients, on arrival in the pre- anesthesia room
Time frame: 1 day
Compare between the experimental group of global warming (RéGlo) and the control group of per- operative warming, the average thermal comfort of preoperative patients, on arrival in the recovering room
Time frame: 1 day
Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, the proportion of patients in intraoperative hypothermia
Time frame: 1 day
Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, The average time spent below 36°C (mild hypothermia)
Time frame: 1 day
Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, The average time spent below 35°C (moderate hypothermia)
Time frame: 1 day
Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, The average time spent below 34°C (severe hypothermia)
Time frame: 1 day
Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, The lowest average temperature reached in °C over the entire management
Time frame: 1 day
Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, The proportion of hypothermic patients arriving in recovering room
Time frame: 1 day
Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, The average duration of oxygen therapy
Time frame: 1 day
Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, Post-intervention complications in recovering room, the average number of Nausea or Vomiting Postoperative
Time frame: 1 day
Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, Post-intervention complications in recovering room, the average number of chills
Time frame: 1 day
Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, Post-intervention complications in recovering room, the average number of stirring phase presence
Time frame: 1 day
The average amount of blood loss per operation
Time frame: 1 day
The average of immediate post-operative blood loss
Time frame: 1 day
The general average of the thermal variation
Time frame: 1 day
The average of thermal variation in pre operative
Time frame: 1 day
The average thermal variation in per operative
Time frame: 1 day
the average thermal variation in post operative
Time frame: 1 day
The average length of stay in recovering room
Time frame: 1 day
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 29 Sep 2026.
- Background: PubMed 31869333Alfonsi P, Bekka S, Aegerter P; SFAR Research Network investigators. Prevalence of hypothermia on admission to recovery room remains high despite a large use of forced-air warming devices: Findings of a non-randomized observational multicenter and pragmatic study on perioperative hypothermia prevalence in France. PLoS One. 2019 Dec 23;14(12):e0226038. doi: 10.1371/journal.pone.0226038. eCollection 2019.
- 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.
Matthieu Boisson, Pu-Ph principal investigator
Poitiers University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing global warming and per operative warming in people with Hypothermia; Anesthesia and Perioperative/Postoperative Complications, run by Poitiers University Hospital 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 1 inclusion and 3 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 29 Sep 2026. 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?
Compare between the experimental group of global warming (RéGlo) and the control group of per-operative warming, the prevalence of hypothermia at the exit of Interventional for patients who underwent laparoscopic visceral surgery. (time frame: 1 day). 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 NCT06551558, 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 29 Sep 2026.