Comparison of an Inhaled Sedation Strategy to an Intravenous Sedation Strategy in Intensive Care … (NCT04341350) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Comparison of an Inhaled Sedation Strategy to an Intravenous Sedation Strategy in Intensive Care Unit Patients Treated With Invasive Mechanical Ventilation
France250 participantsStarted 2020-08-06
Plain-language summary
The objective of the study is to determine the impact on the frequency of occurrence of delirium of an early inhaled sedation strategy (from induction in rapid sequence if intubation in intensive care, or from admission if intubated in pre -hospital) by Isoflurane using an ANACONDA ™ type system, compared to a conventional intravenous sedation strategy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient aged 18 and over
* Patient requiring mechanical ventilation for at least 24 hours
* The patient requires continuous and immediate sedation for more comfort, safety and to facilitate the administration of survival measures.
* Consent obtained from patient or relative
Exclusion Criteria:
Patient hospitalized for the following reasons for admission:
* Cardiac arrest
* State of refractory epilepticus
* Head trauma
* Stroke
* Hearing, visual or aphasia disorders before inclusion making it impossible to take the CAM-ICU
* Sedation started more than 24 hours ago
* Impairment of cognitive functions and / or dementia
* Contraindication to halogenated gases (personal or family history of malignant hyperthermia, acute or chronic neuromuscular disease, hepatocellular insufficiency with PT \<30%)
* Severe acute respiratory distress syndrome (ARDS) (Berlin criteria: PaO2 / FiO2 \<100 after ventilatory optimisation))
* PaCO2 at inclusion\> 50 mmHg after ventilatory optimisation
* Patient for whom a procedure of "limitation of active therapies" is envisaged at inclusion
* Patient under guardianship or curatorship
* Minor patient
* Pregnant or breastfeeding woman
* Patient not affiliated to the social security scheme
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.