Efficiency of Coupling Targeted Temperature Management to Brain Temperature in Severe Brain Injury (BRAINTTM)

Fondation Ophtalmologique Adolphe de Rothschild

Status: Completed

Conditions: Brain Injuries

Treatments: Device: external cooling with the xxxxx device

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT03967626

NED_2019_7

Details and patient eligibility

About

In severe brain-injured patients, it is recommended to strictly control the fever in order to limit brain damage (objective of neuroprotection) via the targeted temperature management (TTM). In the guidelines, the target temperature is the systemic temperature, just for practical reasons (brain temperature not being monitored in most polyvalent ICU). However, in NICU, the brain temperature is monitored routinely via the Intra-Cerebral Pressure (ICP) sensor. Since in the febrile brain-injured patients the objective of the TTM is neuroprotection, it would be more appropriate to target temperature control over the cerebral temperature.

The objective of this study is to evaluate the efficacy of TTM directly coupled to the brain temperature.

Adult patients with brain injury requiring ICP monitoring (Pressio 2, Sophysa France) and fever requiring TTM (cerebral greater than or equal to 38.5 °C) will be enrolled. The TTM will be carried out according to the usual methods of the investigator's service: external cooling devices coupled with cerebral temperature (Artic Sun, Bard France), including two phases: the cooling phase (H0 to H3) and the maintenance phase (from H3 to the end of the cooling).

Two groups will be formed. In the interventional group, coupling of the TTM will be carried out to the cerebral temperature. In the control group, coupling of the TTM will be carried out to the systemic temperature measured at the bladder site.

The primary outcome will be the percentage of time during which the cerebral temperature will be measured within recommended target temperature range (i.e. 36 to 37 °C) during the maintenance phase (H3 to H12): comparison of averages. Cerebral hemodynamic parameters (ICP, transcranial doppler, and brain tissue oxygen partial pressure if available) will also be collected, in order to be correlated with the delta temperature (cerebral temperature minor systemic temperature).

No medical device will be put in place specifically for the need of the study.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients 18 years of age or older
• hospitalized patient in neuro-resuscitation with peak monitoring with cerebral temperature measurement by an intra-parenchymal sensor (Sophysa®)
• patient in hyperthermia (TC ≥ 38.5 °c) and in a situation of brain pain

Exclusion criteria

• patient benefiting from a legal protection measure
• pregnant or breastfeeding woman
• previous participation in this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

41 participants in 2 patient groups

Cerebral temperature target

Experimental group

Description:

CCT performed by the external cooling device with cerebral temperature target, measured by a intracranial sensor (coupled to the intracranial pressure device)

Treatment:

Device: external cooling with the xxxxx device

Systemic temperature target

Active Comparator group

Description:

CCT performed by the external cooling device with systemic temperature target, measured by a bladder sensor (coupled to the vesal probe, according to the standard service protocol).

Treatment:

Device: external cooling with the xxxxx device