Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02575989 |
| Other study ID # |
131204 |
| Secondary ID |
2014-A00564-43 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 17, 2016 |
| Est. completion date |
January 16, 2020 |
Study information
| Verified date |
August 2020 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to demonstrate that the specific management will increase the
number of alive trauma patient arriving with a temperature > 35°C.
Description:
Trauma patients are often hypothermic (temperature < 35 °C) upon arrival at the hospital.
Hypothermia is with hypotension and hypoxia, perfectly known to be directly responsible for
complications.
Hypothermia is responsible, with acidosis and coagulopathy, of the " lethal triad" of trauma.
Thus, it is clearly established that hypothermia is directly associated with poor prognostic
in trauma patients. In a recent study, mortality rate reached 100% for trauma patients
arriving at the hospital with a body temperature below 32°C.
The weather, the severity of the trauma and medical (or paramedical) interventions are
responsible for the onset of this hypothermia.
Then, continuous monitoring of the patient's temperature, active protection against
hypothermia with a metal blanket, the warming (and measure the temperature of) infusion
fluids, the warming (and measure the temperature of) the ambulance should improve patient's
outcome. As hypothermia is associated with mortality of trauma patients, the control must
lead to reduce mortality.
Randomization Due to the use of a global management strategy with combination of several
specific interventions and the need for special equipment (heating devices infusion fluids),
randomization will be done by investigator center: interventional center (combining the
different interventions) and standard management (without modification, except measurements
of the patient's and air temperature at inclusion and on arrival at a receiving center.
In this context, it is also crucial that the weather conditions, the characteristics of
trauma and patients were similar in both groups. Also, 12 investigation centers will be
classified based on annual local average temperatures.
Main collected data Demographics and morphological traits (age, sex, body weight, and height
of the victim), the nature and circumstances of the accident (date, time, place), the
victim's presentation on mobile intensive care unit (MICU) arrival (trapped or not, seated or
lying down, on the ground, unclothed, wet, or covered by a blanket, environmental conditions,
clinical factors, and care provided.
Environmental conditions included air (indoors or outdoors) temperature, and rain at the site
of the accident as well as mobile intensive care unit temperature.
Clinical factors included: the site and nature of the lesions (fracture, wound, contusion),
heart rate, the Revised Trauma Score (RTS) (Glasgow Coma Score (GCS) + systolic blood
pressure + respiratory rate), oxygen saturation or oxygen delivery, and tympanic temperature.
Whenever applicable: vascular filling (infusion fluid temperature and volumes), catecholamine
and morphine administration, any other drugs (with doses), orotracheal intubation.
Times from the accident to MICU arrival and from MICU arrival to hospital admission.
Statistical analysis Primary endpoint: rate of patients arriving at the hospital with a
temperature <35°C. These data will be analyzed by model of multi-level logistic regression to
again consider the cluster design of the study. A secondary analysis will enter the model
known a priori factors that may affect hypothermia. The parameters corresponding to the
secondary objectives will be entered in a model of logistic regression multivariate thereby
specifically test their effect on the criteria studied.
Secondary endpoints: Binary secondary endpoints will be analyzed by model of multi-level
logistic regression. Quantitative secondary endpoints will be analyzed by mixed model ANCOVA
introducing randomness in the center. The variables may be processed before analysis for
non-Gaussian distribution. In case of failure of the normalizing transformation, exact
procedure may be used.
Number of patients to include The calculation of the sample size was based on our previous
study.* The incidence of hypothermia on arrival at the hospital was 14%. By selecting
high-risk patients, the investigators expect an incidence of about 20%. The objective is to
achieve a reduction of one third of hypothermia (i.e. from 20 to 13 %). Using a two-tailed
test at α risk of 0.05 and 1 - beta 0.8, the calculation of required number of patients is
440 per group. Assuming a moderate inflation factor of about 1.35 related to the cluster
randomization (our experience shows that intra-cluster correlation coefficients are low) the
total number of patients per group will be 600 patients.
A total of N = 1,200 patients for the study.
