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Comparison of an Inhaled Sedation Strategy to an Intravenous Sedation Strategy in Intensive Care Unit Patients Treated With Invasive Mechanical Ventilation

Study acronym: INASED
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Aug 2025 to Sep 14, 2025
    • Study completion date: Aug 2026 to Sep 2, 2026
    • Site details revised at 12 of 12 sites
    v13
  2. Site contacts updated at 1 of 12 sitesv12
  3. Phase: Not applicable to Phase 3
    • Primary completion date: Sep 2024 to Aug 2025
    • Study completion date: Aug 2025 to Aug 2026
    v11
  4. Study sites: 11 to 12v10
  5. Site details revised at 1 of 11 sitesv9
Show 7 earlier versionsHide 7 earlier versions
  1. Eligibility criteria expanded, about 6 wordsv8
  2. Primary completion date: Sep 2022 to Sep 2024
    • Study sites: 8 to 11
    • Study completion date: Aug 2023 to Aug 2025
    v7
  3. Re-verified, no change to tracked fieldsv6
  4. Study sites: 1 to 8
    • Interventions: Isoflurane + morphine (Drug), Propofol + morphine (Drug) to Isoflurane + analgesic drug (Drug), Propofol + analgesic drug (Drug)
    • Secondary endpoints: 3 to 16
    v5
  5. Start date changed from estimate of Aug 2020 to Aug 6, 2020v4
  6. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  7. Start date: May 2020 to Aug 2020
    • Primary completion date: Jun 2022 to Sep 2022
    • Study completion date: May 2023 to Aug 2023
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The objective of the study is to determine the impact on the frequency of occurrence of delirium of an early inhaled sedation strategy (from induction in rapid sequence if intubation in intensive care, or from admission if intubated in pre -hospital) by Isoflurane using an ANACONDA ™ type system, compared to a conventional intravenous sedation strategy.
Trial Details
NCT Number NCT04341350
Lead Sponsor University Hospital, Brest
Conditions
(from sponsor)		 Prevention of Delirium
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov