HypothermiaTHERMOTRAUMANCT03970915
Warm-up Efficiency by Body Warmer Versus Standard Procedure in Severely Traumatized Patients
A study testing Body warmer and Standard warming procedure in people with Hypothermia and Trauma, Psychological, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Study of adult patients with severe all-cause trauma having a body temperature less than 36°Celsius (C) that is managed by a Mobile Emergency Service team and oriented towards a Vital Emergency Room. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypothermia, Trauma, Psychological
- What is being tested?
- Body warmer and Standard warming procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteFrance
- Study dates
- 17 Oct 2019to 27 Apr 2022
- 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
- Major patient with all-cause trauma Grade A or B
- Patient with a trans-tympanic body temperature of less than 36°Celsius (C) at primary management by terrestrial or heliport Mobile Emergency Service team.
Who cannot join
- Patient initially supported by a pre-hospital medical team who does not participate in the study,
- Patient with cardiopulmonary arrest at initial pre-hospital medical team management,
- Patient with bilateral otorrhagia (due to the non-feasibility of trans tympanic temperature),
- Patient with inguinal crease or subclavicular fossa injury,
- Patient with severe burn (Burnt Body Surface> 20%),
- Patient deprived of liberty including patients with an electronic bracelet.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Warm-up Efficiency by Body Warmer Versus Standard Procedure in Severely Traumatized Patients During Pre-hospital Medical Management
Study of adult patients with severe all-cause trauma having a body temperature less than 36°Celsius (C) that is managed by a Mobile Emergency Service team and oriented towards a Vital Emergency Room.
Currently two devices are used to warm patients during their care at the scene of an accident: a survival blanket and heating in the emergency vehicle. Despite these two devices many patients arrive in hypothermia (body temperature less than 36°C) in emergency departments. The objective of this study is to evaluate the effectiveness of a body warmer associated with standard warming devices on the correction of hypothermia compared to the standard procedure in severely traumatized patients with hypothermia .
Read more
It is a national multicentric study with 14 participating Mobile Emergency Service centers and hopefully will include 612 patients.
The study will be carried out according to a pattern of 28 successive periods of one week each during the winter period (October to April), for a total duration of 7 months. 14 action periods ON (warming standard procedure + body warmer) and 14 control periods OFF (warming standard procedure) will be run in random order for each center.
- Conditions
- Hypothermia, Trauma, Psychological
- Being tested
- Body warmer, Standard warming procedure
- Keywords
- body warmer, pre-hospital
- Medical subject headings
- Hypothermia, Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body warmerDevice
The body warmer will be wrapped in a waterproof treatment field to avoid the risk of burns, 2 body warmer will be applied on the inguinal crease and 2 on the subclavicular fossa.
Standard warming procedureDevice
Warming only according to the standard procedure : survival blanket and heating in the emergency vehicle.
| Study group | Role | What they receive |
|---|---|---|
| ON (standard warming process + body warmer) | Experimental | Patients included during the ON periods will constitute the experimental group. Warming will be provided by the body warmer in addition to the standard warming procedure (survival blanket and heating in the emergency vehicle). Receives: Device: Body warmer |
| OFF / Control group (standard warming process ) | Sham comparator | Patients included during the OFF periods will constitute the control group. Warming will be provided by the standard warming procedure : survival blanket and heating in the emergency vehicle. Receives: Device: Standard warming procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a temperature > 36°C when the patient arrived in the Vital Emergency
Body temperature will be measured in trans-tympanic when the patient arrived in the Vital Emergency Room.
Measured: 4 hours
Secondary outcomes (9)
Change in body temperature between initial treatment by the Mobile Emergency Service team and arrival at Vital Emergency Room.
Body temperature will be measured in trans-tympanic every 15 minutes between initial treatment by the pre-hospital medical team and arrival at emergency room.
Measured: 4 hours
Proportion of patients with coagulopathy on arrival at the emergency room.
Coagulopathy refers to disorders of blood coagulation whether they are pathological thrombosis or haemorrhagic syndromes. The coagulopathy criteria appear early and their measurements are systematically carried on admission to the emergency room.
Measured: 4 hours
Proportion of patients with acidosis on arrival at the emergency room.
Acidosis is a disorder of the acid-base balance of the body corresponding to an increase in the concentration of acid in plasma and interstitial fluids. It can be metabolic or respiratory. In the case of a state of shock, lactic acid occurs in situations where the tissues of the body are poorly irrigated and lack oxygen.
Measured: 4 hours
Evaluation of mortality
Proportion of deaths at one month (72h after admission to emergency room).
Measured: 72 hours
Evaluation of mortality (deaths before admission )
Proportion of deaths before admission to emergency room.
Measured: 72 hours
Evaluation of mortality (cardio respiratory arrest)
Proportion of cardio respiratory arrest before admission to emergency room.
Measured: 72 hours
Loss of heat due to a drop of temperature
Measured: 4 hours
First degree burn
Measured: 4 hours
Patient feels cold
Measured: 4 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 2019
- Study start17 Oct 2019
- Primary completion27 Apr 2022
- Study completion27 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Delphine HUGENSCHMITT, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970915
- Sponsor's protocol ID
- 69HCL19_0033
- Other IDs
- 2019-A01163-54
- Acronym
- THERMOTRAUMA
- Status last verified
- May 2022
- First submitted
- 15 May 2019
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Warm-up Efficiency by Body Warmer Versus Standard Procedure in Severely Traumatized Patients During Pre-hospital Medical Management
- ClinicalTrials.gov ID
- NCT03970915
- Acronym / sponsor ID
- THERMOTRAUMA / 69HCL19_0033
- Conditions
- Hypothermia, Trauma, Psychological
- Keywords
- body warmer, pre-hospital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 17 Oct 2019 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 27 Apr 2022 (actual)
- First posted
- 3 Jun 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.
Study of adult patients with severe all-cause trauma having a body temperature less than 36°Celsius (C) that is managed by a Mobile Emergency Service team and oriented towards a Vital Emergency Room.
Currently two devices are used to warm patients during their care at the scene of an accident: a survival blanket and heating in the emergency vehicle. Despite these two devices many patients arrive in hypothermia (body temperature less than 36°C) in emergency departments. The objective of this study is to evaluate the effectiveness of a body warmer associated with standard warming devices on the correction of hypothermia compared to the standard procedure in severely traumatized patients with hypothermia .
It is a national multicentric study with 14 participating Mobile Emergency Service centers and hopefully will include 612 patients.
The study will be carried out according to a pattern of 28 successive periods of one week each during the winter period (October to April), for a total duration of 7 months. 14 action periods ON (warming standard procedure + body warmer) and 14 control periods OFF (warming standard procedure) will be run in random order for each center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ON (standard warming process + body warmer) | Experimental | Device: Body warmerPatients included during the ON periods will constitute the experimental group. Warming will be provided by the body warmer in addition to the standard warming procedure (survival blanket and heating in the emergency vehicle). |
| OFF / Control group (standard warming process ) | Sham comparator | Device: Standard warming procedurePatients included during the OFF periods will constitute the control group. Warming will be provided by the standard warming procedure : survival blanket and heating in the emergency vehicle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Major patient with all-cause trauma Grade A or B
- Patient with a trans-tympanic body temperature of less than 36°Celsius (C) at primary management by terrestrial or heliport Mobile Emergency Service team.
Key exclusion criteria (6 listed)
- Patient initially supported by a pre-hospital medical team who does not participate in the study,
- Patient with cardiopulmonary arrest at initial pre-hospital medical team management,
- Patient with bilateral otorrhagia (due to the non-feasibility of trans tympanic temperature),
- Patient with inguinal crease or subclavicular fossa injury,
- Patient with severe burn (Burnt Body Surface> 20%),
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 |
|---|---|---|
| Body warmerThe body warmer will be wrapped in a waterproof treatment field to avoid the risk of burns, 2 body warmer will be applied on the inguinal crease and 2 on the subclavicular fossa. | Device | ON (standard warming process + body warmer) |
| Standard warming procedureWarming only according to the standard procedure : survival blanket and heating in the emergency vehicle. | Device | OFF / Control group (standard warming process ) |
Primary outcome
Proportion of patients with a temperature > 36°C when the patient arrived in the Vital Emergency
Time frame: 4 hours
Body temperature will be measured in trans-tympanic when the patient arrived in the Vital Emergency Room.
9 secondary outcomes
Change in body temperature between initial treatment by the Mobile Emergency Service team and arrival at Vital Emergency Room.
Time frame: 4 hours
Proportion of patients with coagulopathy on arrival at the emergency room.
Time frame: 4 hours
Proportion of patients with acidosis on arrival at the emergency room.
Time frame: 4 hours
Evaluation of mortality
Time frame: 72 hours
Evaluation of mortality (deaths before admission )
Time frame: 72 hours
Evaluation of mortality (cardio respiratory arrest)
Time frame: 72 hours
Loss of heat due to a drop of temperature
Time frame: 4 hours
First degree burn
Time frame: 4 hours
Patient feels cold
Time frame: 4 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 3 Jun 2022.
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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.
Delphine HUGENSCHMITT principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body warmer and Standard warming procedure in people with Hypothermia and Trauma, Psychological, run by Hospices Civils de Lyon 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 3 Jun 2022. 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. Some participants in this study may receive a placebo. 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?
Proportion of patients with a temperature > 36°C when the patient arrived in the Vital Emergency (time frame: 4 hours). 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 2022.