Severe Brain InjuryTODAYNCT04109430
Study of PbiO2 Variation by Body Temperature and Capnia in Severe Head Trauma Patients Treated With Targeted Temperature Control
An observational study of Severe Brain Injury, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Severe Brain Injury
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2019to 1 Mar 2020
- Phase
- Observational
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- initial bilateral mydriasis
- no information of the family
- refusal of participation.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
HUET
Brest, Brittany Region, 29200
Olivier Huet, 09 98 34 72 88, olivier.huet@chu-brest.fr
09 98 34 72 88, olivier.huet@chu-brest.fr
About this study
Official title: Study of PtiO2 Variation by Body Temperature and Capnia in Severe Head Trauma Patients With Intracranial Refractory Hypertension Treated With Targeted Temperature Control
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.
Read more
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.
Read the detailed description
This is a prospective, non-interventional, mono-centric study at surgical intensive care unit at Brest medical university hospital.
This study will be conducted in a reference center for the management of patients with traumatic brain injury, who is used to collect prospective data.
The clinical research structure of Brest Medical University allows data analysis and the investigators have the clinical knowledge for their interpretation.
After verification of the inclusion and non-inclusion criteria and information of the family (parent or relative) or the holder of parental authority, patients will be included in order of arrival in the service.
The population studied is the trauma brain injured patients with an initial Glasgow coma scale of less than 8 at pre-hospital care or neurological impairment with Glasgow Coma Scaleless than 8 in the first 24 hours after admission to intensive care.
The installation of a intra-cranial pressure/ PbtO2 probe (INTEGRA Licox PtO2 monitor) is performed by the neurosurgeon according to the protocol service.
Approximately 30 patients were monitored with a PbtO2 sensor in 2018 in the Surgical intensive care unit at Brest Medical University Hospital.
After verification of inclusion and non-inclusion criteria, oral and written information will be given to parent or relative of the patient. A no-objection form will be sent to the patient as soon as possible to confirm his participation.
Follow-up of the patient is carried out until discharge of intensiv care unit. The duration of participation in the study is the duration of treatment by targeted temperature control, very variable depending on the clinical evolution of patients, from 1 day to more than one week. The management of the patients included in this study is not modified in relation to the treatment usually recommended in the intensiv care unit.(based on French recommendation).
In order to describe the variations of PbtO2 values, the PbtO2 values are collected at time T0 before induction of targeted temperature control, at time T1: the first hour of the targeted temperature control phase (<35 ° C) at time T2: during the phase of temperature stability (<35 ° C) defined as two successive hours of hypothermia, at time T3 defines as 6 hours at a stable temperature in hypothermia, then once a day up to the end of the targeted temperature control phase.
Then the values of PtiO2 are collected during the daily hypercapnia test during targeted temperature control phase.
Demographic data collected are age, sex, weight, height, and data on gravity at the entrance: IGS2 score, first Glasgow Coma scale score, time to CT-scan and IMPACT score.
Data on time to PbtO2 probe and ICP probe insertion and time to equilibration of PbtO2 value.
Data were collected at all times, T0, T1, T2, T3 (as defined above) and daily: the body temperature (collected by esophageal thermal probe), the cerebral perfusion pressure, the value of PtiO2 / PIC, FiO2 / etCO2, an arterial blood sample, a blood count and a daily ionogram,daily transcranial Doppler data, doses of amines, curares and sedation.
During the stay were collected: time to and nature of the surgical procedure and realization of a craniectomy or not, position of the PtiO2 probe on a control scanner, an at the discharge: prognosis score (GOS-E),lenght of stay in intensive care unit, death in intensive care unit.
- Conditions
- Severe Brain Injury
- Keywords
- PbtO2, hypothermia, trauma brain injury, targeted control temperature, refractory brain hypertension
- Medical subject headings
- Brain Injuries, Hypothermia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year (through study completion)
Secondary outcomes (1)
Changes in PtiO2 gross values during hypercapnia test
Description of variations values of PbtO2 during hypercapnia test induced by ventilation minute reduction, performed to assess brain tolerance to possible warming.
Measured: 1 year (through study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start1 Mar 2019
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Brain InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109430
- Sponsor's protocol ID
- TODAY STUDY (29BRC19.0064)
- Acronym
- TODAY
- Status last verified
- Sep 2019
- First submitted
- 19 Sep 2019
- Last updated
- 30 Sep 2019
- 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 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of PtiO2 Variation by Body Temperature and Capnia in Severe Head Trauma Patients With Intracranial Refractory Hypertension Treated With Targeted Temperature Control
- ClinicalTrials.gov ID
- NCT04109430
- Acronym / sponsor ID
- TODAY / TODAY STUDY (29BRC19.0064)
- Conditions
- Severe Brain Injury
- Keywords
- PbtO2, hypothermia, trauma brain injury, targeted control temperature, refractory brain hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 30 Sep 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.
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.
Detailed description
This is a prospective, non-interventional, mono-centric study at surgical intensive care unit at Brest medical university hospital.
This study will be conducted in a reference center for the management of patients with traumatic brain injury, who is used to collect prospective data.
The clinical research structure of Brest Medical University allows data analysis and the investigators have the clinical knowledge for their interpretation.
After verification of the inclusion and non-inclusion criteria and information of the family (parent or relative) or the holder of parental authority, patients will be included in order of arrival in the service.
The population studied is the trauma brain injured patients with an initial Glasgow coma scale of less than 8 at pre-hospital care or neurological impairment with Glasgow Coma Scaleless than 8 in the first 24 hours after admission to intensive care.
The installation of a intra-cranial pressure/ PbtO2 probe (INTEGRA Licox PtO2 monitor) is performed by the neurosurgeon according to the protocol service.
Approximately 30 patients were monitored with a PbtO2 sensor in 2018 in the Surgical intensive care unit at Brest Medical University Hospital.
After verification of inclusion and non-inclusion criteria, oral and written information will be given to parent or relative of the patient. A no-objection form will be sent to the patient as soon as possible to confirm his participation.
Follow-up of the patient is carried out until discharge of intensiv care unit. The duration of participation in the study is the duration of treatment by targeted temperature control, very variable depending on the clinical evolution of patients, from 1 day to more than one week. The management of the patients included in this study is not modified in relation to the treatment usually recommended in the intensiv care unit.(based on French recommendation).
In order to describe the variations of PbtO2 values, the PbtO2 values are collected at time T0 before induction of targeted temperature control, at time T1: the first hour of the targeted temperature control phase (<35 ° C) at time T2: during the phase of temperature stability (<35 ° C) defined as two successive hours of hypothermia, at time T3 defines as 6 hours at a stable temperature in hypothermia, then once a day up to the end of the targeted temperature control phase.
Then the values of PtiO2 are collected during the daily hypercapnia test during targeted temperature control phase.
Demographic data collected are age, sex, weight, height, and data on gravity at the entrance: IGS2 score, first Glasgow Coma scale score, time to CT-scan and IMPACT score.
Data on time to PbtO2 probe and ICP probe insertion and time to equilibration of PbtO2 value.
Data were collected at all times, T0, T1, T2, T3 (as defined above) and daily: the body temperature (collected by esophageal thermal probe), the cerebral perfusion pressure, the value of PtiO2 / PIC, FiO2 / etCO2, an arterial blood sample, a blood count and a daily ionogram,daily transcranial Doppler data, doses of amines, curares and sedation.
During the stay were collected: time to and nature of the surgical procedure and realization of a craniectomy or not, position of the PtiO2 probe on a control scanner, an at the discharge: prognosis score (GOS-E),lenght of stay in intensive care unit, death in intensive care unit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- initial bilateral mydriasis
- no information of the family
- refusal of participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in PbtO2 gross values during the targeted temperature control phase
Time frame: 1 year (through study completion)
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 secondary outcome
Changes in PtiO2 gross values during hypercapnia test
Time frame: 1 year (through study completion)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Brain Injury, run by University Hospital, Brest 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 Sep 2019. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier HUET (9 98 34 72 88 ext. +33, olivier.huet@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in PbtO2 gross values during the targeted temperature control phase (time frame: 1 year (through study completion)). 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 30 Sep 2019.