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Inhaled Sedation in Critically Ill Patients

ConditionsSedationAirway Extubation
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Isoflurane

    Drug

    Inhaled sedation with isoflurane via Sedaconda ACD-S

  • Propofol

    Drug

    Intravenous sedation with Propofol 20 mg/ml

Treatment groups

620 Participants
are divided into 2 treatment groups
Group A: Study groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Ventilator-free days at day 28 from randomization

Number of days between randomization and day 28 during which the patient is alive and free from invasive mechanical ventilation. Patients who die before day 28, or who remain on mechanical ventilation at day 28, are assigned zero ventilator-free days.

Time frame
From randomization until day 28

Secondary outcomes

1

Key secondary objective: ICU-free days at day 28 post-randomization

Number of days between randomization and day 28 during which the patient is alive and free from the ICU. Patients who die before day 28, or remain in the ICU on day 28, are assigned zero ICU-free days.

Time frame
From randomization until day 28
2

Time to extubation

Mean number of hours from sedation withdrawal to successful extubation.

Time frame
From randomization until day 28
3

Administration of rescue sedation

Number of patients requiring the addition of one or more hypnotics

Time frame
From randomization until day 28
4

Sedation efficacy

Difference between the target sedation level and the actual measured level using Richmond Agitation Sedation Scale (RASS). Possible RASS score ranges from -5 (unarousable) to +4 (combative)

Time frame
From randomization until extubation or day 28

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Instituto de Investigación Hospital Universitario La Paz

Lead sponsor

Instituto de Salud Carlos III

Collaborator

Source ClinicalTrials.gov
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