Expanded Access for Inhaled Isoflurane Delivered Via the Sedaconda ACD-S for Sedation of Difficul… (NCT07457593) | Clinical Trial Compass
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Expanded Access for Inhaled Isoflurane Delivered Via the Sedaconda ACD-S for Sedation of Difficult-to-Sedate Adult Mechanically Ventilated Intensive Care Unit Patients
Plain-language summary
The purpose of this Expanded Access Protocol is to provide access to inhaled isoflurane delivered via the Sedaconda ACD-S device for sedation of adult patients in the ICU that are mechanically ventilated and are difficult to sedate with current available treatment options, and who, in the opinion of their treating physician, would benefit from this treatment.
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
. recurring episodes of agitation or self-harm, such as attempting or actual removal of an endotracheal tube or of indwelling catheters or monitors, or necessitating physical restraints; or
. escalating sedative and opioid drug doses, despite mitigating strategies (e.g., sedative drug combinations or rotation to reduce toxicity); or
. clinical concerns for, or indications of, serious untoward effects of ongoing conventional intravenous sedation and analgesia agents (e.g., hypertriglyceridemia, propofol-related infusion syndrome, bradycardia, iatrogenic withdrawal syndrome); and
Exclusion criteria
. Known or suspected personal or family history of malignant hyperthermia (MH) or high risk for MH or acute drug-induced muscle injury (eg, muscular dystrophies);
. Severe hemodynamic compromise;
. Known hypersensitivity reaction to isoflurane or other halogenated volatile anesthetic agents
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.