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Tests treatment safety and results for Traumatic Brain Injury
Official title Evaluation of the Safety of Inhaled Sedation With Isoflurane in Head Trauma Patients
ClinicalTrials.gov ID: NCT06311604
What this study is testing
What is Isoflurane?
Isoflurane is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for traumatic brain injury.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Intensive care management of patient with severe traumatic brain injury (TBI) includes deep and prolonged sedation with intravenous hypnotics (propofol, midazolam, ketamine) in combination with opioids to prevent and/or treat episodes of intracranial hypertension. However, some patients may develop tachyphylaxis with a gradual increase of administered intravenous hypnotics and opioids to maintain the same level of sedation.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient \> 18 years old
- Hospitalized in surgical intensive care (CPR and RNC) for severe head trauma
- On intravenous hypnotic therapy for at least 24 hours with at least 2 lines of IV hypnotics and requiring continued sedation for at least 24 hours...
- Initial ICP \< 15 mmHg on introduction of isoflurane
- Functional intracranial pressure sensor
You likely can't join if
- Patients who have had a decompressive craniectomy
- Patients with a personal or family history of malignant hyperthermia
- Patients with a history of long QT syndrome
- Patients taking MAOI-type antidepressants (iproniazid (MARSILID) and moclobemide (MOCLAMIDE))
- Patients with known hypersensitivity to isoflurane or other volatile halogenated anaesthetic agents
- Patients who have experienced liver damage, jaundice, unexplained fever, or eosinophilia after administration of a halogenated anaesthetic.
See the full eligibility criteria
- Patient \> 18 years old
- Hospitalized in surgical intensive care (CPR and RNC) for severe head trauma
- On intravenous hypnotic therapy for at least 24 hours with at least 2 lines of IV hypnotics and requiring continued sedation for at least 24 hours, with a RASS of between -3 and -5
- Initial ICP \< 15 mmHg on introduction of isoflurane
- Functional intracranial pressure sensor
- Transcranial Doppler measurements performed within 24 hours
- Written informed consent from a legal representative/relative/trusted person. In the absence of a legal representative, the patient may be included under the emergency procedure.
- Patients who have had a decompressive craniectomy
- Patients with a personal or family history of malignant hyperthermia
- Patients with a history of long QT syndrome
- Patients taking MAOI-type antidepressants (iproniazid (MARSILID) and moclobemide (MOCLAMIDE))
- Patients with known hypersensitivity to isoflurane or other volatile halogenated anaesthetic agents
- Patients who have experienced liver damage, jaundice, unexplained fever, or eosinophilia after administration of a halogenated anaesthetic.
- Patients expected to die within the next 24 hours
- Subject in a period of exclusion from another clinical trial,
- Technical unavailability of the inhaler
- Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, women in childbirth, nursing mothers, persons deprived of their liberty by judicial or administrative...
- No European social security
The study team makes the final eligibility decision.
Where it's taking place
- Grenoble, Choisir Une Région, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Grenoble, Choisir Une Région, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.