SedationNCT07457593
Expanded Access for Inhaled Isoflurane Delivered Via the Sedaconda ACD-S for Sedation of Difficult-to-Sedate Adult Mechanically Ventilated Intensive Care Unit Patients
A study testing Isoflurane and Sedaconda ACD-S in people with Sedation, run by Sedana Medical.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sedation
- What is being tested?
- Isoflurane and Sedaconda ACD-S
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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
- 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
- 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.
Who cannot join
- 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:
- 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);
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- Severe hemodynamic compromise;
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Sedation
- Being tested
- Isoflurane, Sedaconda ACD-S
- Keywords
- inhaled sedation, Sedaconda ACD-S, Difficult to sedate, Sedana Medical, Sedana
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsofluraneDrug
Isoflurane for inhaled sedation
Sedaconda ACD-SDevice
Sedaconda ACD-S is a medical device which enables the administration of volatile anesthetics (isoflurane)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Sedana Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457593
- Sponsor's protocol ID
- SED006
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access for Inhaled Isoflurane Delivered Via the Sedaconda ACD-S for Sedation of Difficult-to-Sedate Adult Mechanically Ventilated Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT07457593
- Acronym / sponsor ID
- SED006
- Conditions
- Sedation
- Keywords
- inhaled sedation, Sedaconda ACD-S, Difficult to sedate, Sedana Medical, Sedana
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Sedana MedicalIndustry (pharma, biotech, devices)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- 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.
Key exclusion criteria (13 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IsofluraneIsoflurane for inhaled sedation | Drug | – |
| Sedaconda ACD-SSedaconda ACD-S is a medical device which enables the administration of volatile anesthetics (isoflurane) | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Isoflurane and Sedaconda ACD-S in people with Sedation, run by Sedana Medical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ida Sverud, MSc (+46 8 124 05 200, medinfo@sedanamedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.