Expanded Access for Inhaled Isoflurane Delivered Via the Sedaconda ACD-S for Sedation of Difficult-to-Sedate Adult Mechanically Ventilated Intensive Care Unit Patients

March 3, 2026 updated by: Sedana Medical
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.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  • Adults ≥18 years of age;
  • Receiving invasive mechanical ventilation and continuous sedation in the ICU;

  • Inability to maintain a target sedation level ensuring patient comfort and safety with conventional intravenous sedatives, in clinically appropriate combinations and at maximum tolerated doses, despite optimized analgesia and ventilator settings, with

    1. 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
    2. escalating sedative and opioid drug doses, despite mitigating strategies (e.g., sedative drug combinations or rotation to reduce toxicity); or
    3. 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
  • No other available sedative option is considered appropriate
  • Is not currently enrolled in or is eligible for a clinical study that would prohibit the participation in this EAP.

Exclusion Criteria:

  • Ventilator tidal volume <200 or >1000 mL
  • Need for high frequency oscillation ventilation (HFOV) or high frequency percussive ventilation (HFPV)
  • Comfort care only (end of life care);
  • Suspected but unmonitored elevated intracranial pressure (e.g., patients with acute stroke, severe head trauma, meningitis without ICP monitoring);

  • Contraindication to isoflurane, including:

    1. 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);
    2. Severe hemodynamic compromise;
    3. Known hypersensitivity reaction to isoflurane or other halogenated volatile anesthetic agents
  • History of ventricular tachycardia/Long QT Syndrome;
  • Female patients who are pregnant or breast-feeding;
  • Imperative need for continuous active humidification through mechanical ventilation circuit;
  • Any medical conditions, that, in the Investigator´s opinion, would impose excessive risk to the patient or would adversely affect the patient's participation in the EAP;
  • Inability to obtain informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sedana Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 18, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SED006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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