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Taking peoplePhase 4

Inhaled Sedation in Critically Ill Patients

Key facts

Who runs it
Instituto de Investigación Hospital Universitario La Paz
Where
Spain22 sites in 1 countryChoose a country to see its sites
Status
Recruiting
Phase
Phase 4
People taking part
620 people, planned
Started
15 Dec 2025
Expected to end
Dec 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Isoflurane
  • Propofol
Record updated
29 June 2026

Who can take part

Age
18 years to 80 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 22 criteriaShow less

Who can take part

  • Adult patients receiving mechanical ventilation, with an anticipated duration >48 hours after randomization, and requiring deep sedation (target RASS between -3 and -5)

Who cannot take part

  • Patients expected to require repeated surgical interventions during their ICU stay
  • Allergy to isoflurane or propofol
  • Acute neurological condition
  • Neuromuscular disease or high spinal cord injury likely to prevent discontinuation of mechanical ventilation due to baseline condition
  • Any condition (e.g., blindness, deafness, dementia) or language barrier that prevents the administration of delirium or cognitive assessment scales
  • History of ventricular tachycardia or long QT syndrome
  • Contraindication to isoflurane or propofol
  • Patients with maternal ancestry from Venezuela, due to the potential presence of an mt-ND4 gene mutation associated with neurological injury after exposure to certain volatile anaesthetic agents
  • Significant air leak, defined as a leak exceeding 30% of the delivered minute ventilation
  • Cardiopulmonary arrest
  • Tidal volume < 300 mL or PaCO₂ > 50 mmHg at the time of randomization
  • Invasive mechanical ventilation for more than 48 hours at the time of randomization
  • Pregnancy
  • Breast feeding
  • ECMO
  • ECCO2R
  • Active humidification strictly required
  • Requirement for benzodiazepine use for a specific indication
  • Burns
  • Life expectancy less than 48 hours, or patients with such a level of severity that death during the ICU stay is considered highly likely
  • Lack of informed consent

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

The proposal of this study is to compare inhaled sedation with isoflurane administered via the Sedaconda ACD-S system with intravenous sedation with propofol. Patients will be randomized 1:1 to receive either inhaled sedation with isoflurane administered via the Sedaconda ACD device (Sedana Medical, Uppsala, Sweden) or intravenous propofol. The primary endpoint is the number of ventilator-free days at 28 days after randomization.

The 2 groups in the trial

  • Study groupTreatment being tested

    Inhaled sedation with Isoflurane. Initial dose: 3 mL/h. Gradual dose increase until target RASS is achieved. Do not exceed 14 mL/h. Guided by end tidal isoflurane concentration (EtISO), the recommended maximum dose for prolonged use is 1%. Short periods at up to 1.5% may be considered. If the target RASS is not achieved at the maximum dose, a second hypnotic agent may be added.

    Treatment: Isoflurane

  • Control groupExisting treatment, for comparison

    Intravenous sedation with propofol (20 mg/mL). Initial dose: 0.5-1 mg/kg/h. Gradual dose increase until target RASS is achieved. Do not exceed 4 mg/kg/h. If the target RASS is not achieved at the maximum dose, a second hypnotic agent may be added.

    Treatment: Propofol

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Inhaled Sedation in Critically Ill Patients: a Multicentre Randomized Clinical Trial
Fit questions
Built from NCT07000526, who can take part
Record updated
29 June 2026