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Comparison of an inhaled sedation strategy with an intravenous sedation strategy in intensive care patients treated with invasive mechanical ventilation: INASED study
EU CTIS ID: 2024-513530-37-00
What this study is testing
Determine the impact on the frequency of delirium occurrence of an early inhaled sedation strategy (from induction in rapid sequence if intubated in the ICU, or from admission if intubated in the pre-hospital setting) with Isoflurane using an ANACONDA™-type system, compared with a conventional intravenous sedation strategy.
- Therapeutic confirmatory (Phase III)
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
- Patient aged 18 and over
- Patient requires mechanical ventilation for at least 24 hours
- Patient requires immediate continuous sedation for comfort, safety and to facilitate the administration of life-sustaining measures.
- Consent obtained from patient or relative
You likely can't join if
- Patient admitted for the following reasons : - Cardiac arrest - Refractory status epilepticus - Moderate to severe head trauma - Cerebrovascular accident
- Minors
- Pregnant or breast-feeding women
- Patient not affiliated to the social security system
- Auditory or visual impairment, or aphasia prior to inclusion, making CAM-ICU impossible to perform
- Sedation for more than 24 hours
See the full eligibility criteria
- Patient aged 18 and over
- Patient requires mechanical ventilation for at least 24 hours
- Patient requires immediate continuous sedation for comfort, safety and to facilitate the administration of life-sustaining measures.
- Consent obtained from patient or relative
- Patient admitted for the following reasons : - Cardiac arrest - Refractory status epilepticus - Moderate to severe head trauma - Cerebrovascular accident
- Minors
- Pregnant or breast-feeding women
- Patient not affiliated to the social security system
- Auditory or visual impairment, or aphasia prior to inclusion, making CAM-ICU impossible to perform
- Sedation for more than 24 hours
- Impaired cognitive function and/or dementia
- Contraindication to halogenated gas (personal or family history of malignant hyperthermia, acute or chronic neuromuscular disease, hepatocellular insufficiency with TP<30%)
- Severe ARDS (Berlin criteria: PaO2/FiO2<100 after ventilatory optimization)
- PaCO2 at inclusion > 50 mmHg with pH<7.2 after ventilatory optimization
- Patient for whom a "limitation of active therapies" procedure is envisaged on inclusion
- Patient under guardianship or curatorship
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.