AVAILABLENot Applicable

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 range18 Years

SexALL

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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

Trial details

NCT IDNCT07457593

SponsorSedana Medical

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

Contact for this trial

Ida Sverud, MSc

+46 8 124 05 200 medinfo@sedanamedical.com

View on ClinicalTrials.gov More Sedation trials