BridgeMD
EVALUATION OF THE EFFICACY OF INHALATORY SEDATION IN COMPARISON WITH CONVENTIONAL INTRAVENOUS SEDATION IN NEUROCRITIC PATIENTS
EU CTIS ID: 2024-512077-27-00
What this study is testing
1.To evaluate the efficacy and safety of using inhalation sedation with isoflurane in neurocritical patients versus conventional intravenous sedation. 2.NOL monitoring is an effective tool to evaluate the analgesic status of deeply sedated patients.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients equal or older than 18 years old
- Neurocritical patients (intracranial hemorrhage, severe traumatic brain injury, ischemic or hemorrhagic stroke) who, due to their clinical situation and by decision of the treating physician, require advanced neurological monitoring (ICP catheter, DTC...) and deep sedation Intensive Unit Care admission
- Informed consent form signed by a family member/legal representative
You likely can't join if
- Neurocritical patients with risk of CTEH (by imaging techniques) who do not have ICP catheter monitoring
- End-of-life situation or with ICU admission oriented towards donation
- Refusal to informed consent by the relative/legal representative of reference.
- Neurocritical patients monitored with an ICP catheter but with initial values >20 mmHg
- Neurocritical patients with decompressive craniectomy monitored with an ICP catheter and with initial values >13 mmHg.
- Severe hypoxemia (pO2<60mmHg) or high FiO2 requirements (>0.6) and/or high PEEP values (>10mmHg).
See the full eligibility criteria
- Patients equal or older than 18 years old
- Neurocritical patients (intracranial hemorrhage, severe traumatic brain injury, ischemic or hemorrhagic stroke) who, due to their clinical situation and by decision of the treating physician, require advanced neurological monitoring (ICP catheter, DTC...) and deep sedation Intensive Unit Care admission
- Informed consent form signed by a family member/legal representative
- Neurocritical patients with risk of CTEH (by imaging techniques) who do not have ICP catheter monitoring
- End-of-life situation or with ICU admission oriented towards donation
- Refusal to informed consent by the relative/legal representative of reference.
- Neurocritical patients monitored with an ICP catheter but with initial values >20 mmHg
- Neurocritical patients with decompressive craniectomy monitored with an ICP catheter and with initial values >13 mmHg.
- Severe hypoxemia (pO2<60mmHg) or high FiO2 requirements (>0.6) and/or high PEEP values (>10mmHg).
- Patients in shock who require vasoactive support with noradrenaline >0.5mcg/kg/min and/or lactate >2. 5mmol/L.
- Patients who, upon admission, in the initial neurological evaluation with transcranial Doppler, have a negative Giller Test (loss of cerebral self-regulation).
- Patients under 18 years of age.
- Pregnant or breastfeeding patients.
- Patients with any contraindication to the administration of isoflurane
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.