Inhaled Sedation in Critically Ill Patients
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorInstituto de Investigación Hospital Universitario La Paz
About this trial
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.
Eligibility criteria
Qualifiers
None
Disqualifiers
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
Allergy to isoflurane or propofol
Trial design
Treatments tested in this trial
- Isoflurane
- Propofol
Treatment groups
620 Participants
are divided into 2 treatment groupsSponsors and collaborators
Instituto de Investigación Hospital Universitario La Paz
Lead sponsor
Instituto de Salud Carlos III
Collaborator
Source ClinicalTrials.gov