An interventional study of Body warmer and Standard warming procedure in Hypothermia and Trauma, Psychological, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-03.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Treatment
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.
499 studies on the registry are indexed under Hypothermia; 54 are open to participants now.
This study's enrollment of 134 is above the median of 80 across 351 interventional studies indexed under Hypothermia.
Browse Hypothermia studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Device: Body warmer
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.
Device: Standard warming procedure
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.
Warming only according to the standard procedure : survival blanket and heating in the emergency vehicle.
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.
Time frame: 4 hours
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.
Time frame: 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.
Time frame: 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.
Time frame: 4 hours
Evaluation of mortality
Proportion of deaths at one month (72h after admission to emergency room).
Time frame: 72 hours
Evaluation of mortality (deaths before admission )
Proportion of deaths before admission to emergency room.
Time frame: 72 hours
Evaluation of mortality (cardio respiratory arrest)
Proportion of cardio respiratory arrest before admission to emergency room.
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
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospices Civils de Lyon