Study of PbiO2 Variation by Body Temperature and Capnia in Severe Head Trauma Patients Treated With Targeted Temperature Control

NCT04109430 | Unknown

• 1 other identifier: TODAY STUDY (29BRC19.0064)
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Serious head trauma is a common and pathology and responsible of high morbidity and mortality. The major challenge, from the very first hours, is to limit cerebral ischemia by controlling secondary brain injury factors. These parameters must be integrated early in order to guide the better cerebral resuscitation. Brain monitoring is multimodal:transcranial Doppler, intracranial pressure sensor, cerebral tissue pressure in O2. In the case of refractory intracranial hypertension to well-conducted medical treatment, targeted temperature control showed its efficacy on the control of intracranial pressure. There are few data in the literature on PbtO2 modifications during therapeutic hypothermia. PbtO2 monitoring is now commonly used according to literature data, showing the benefit of the latter but the interpretation of its values during the phase of targeted temperature control is not known. Due to the lack of data on the variation of values of PbtO2 during the hypothermia phase, values falsely comfortable or falsely weak could lead respectively to a lack of support of an episode of tissue hypoxia or the introduction of unjustified aggressive therapeutics.

Conditions

Severe Brain Injury

Keywords

PbtO2; hypothermia; trauma brain injury; targeted control temperature; refractory brain hypertension

Outcome Measures

Primary Outcomes (1)

• Changes in PbtO2 gross values during the targeted temperature control phase

  Evaluated at the time T0 before induction of the targeted control of the temperature, at time T1: the first hour of the targeted temperature control phase (\<35 ° C), at time T2: during the stability phase of the temperature (\<35 ° C) defines as two successive hours of hypothermia, at time T3 defines as 6 hours at a stable temperature under hypothermia, then once a day until the control phase targeted temperature stops.

  1 year (through study completion)

Secondary Outcomes (1)

• Changes in PtiO2 gross values during hypercapnia test

  1 year (through study completion)

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Organized and practiced on the human being for the development of biological and medical knowledge, in which the acts are practiced and the products used in the usual way, without additional or unusual procedure of diagnosis, treatment or monitoring.

You may qualify if:

• age\> 15 years
• severe traumatic brain injury defined by an initial Glasgow Coma Scale score less than 8 or neurological impairment in the first 24 hours with Glasgow less than 8,
• brain hypertension refractory despite usual sedation and control of ACSOS (ICP\> 20mmHg for more than 15 minutes over a period of one hour)
• Participation Agreement.

You may not qualify if:

• initial bilateral mydriasis
• no information of the family
• refusal of participation.

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

HUET

Brest, Brittany Region, 29200, France

RECRUITING

MeSH Terms

Conditions

Brain Injuries; Hypothermia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Olivier HUET

CONTACT

9 98 34 72 88; olivier.huet@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 30, 2019
• Study Start: March 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: September 30, 2019

Record last verified: 2019-09

Locations

FR (1)