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Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults

Study acronym: inDEX
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Collaborators expanded, about 4 wordsv7
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 28, 2025 to Jul 29, 2025
    • Site details revised at 6 of 6 sites
    v6
  3. Start date: May 31, 2025 to Jul 28, 2025
    • Eligibility criteria expanded, about 8 words
    • Study description expanded, about 13 words
    v5
  4. Start date: Jan 31, 2025 to May 31, 2025
    • Study sites: 0 to 6
    v4
  5. Primary completion date: Jan 2, 2025 to Dec 31, 2029v3 Show 6 more changesShow less
    • Start date: Oct 2, 2024 to Jan 31, 2025
    • Enrollment target: 826 to 846
    • Study completion date: Jan 2, 2025 to Jan 31, 2030
    • Eligibility criteria expanded, about 78 words
    • Secondary endpoints: 10 to 5
    • Study description revised
  6. Start date: Mar 2, 2024 to Oct 2, 2024v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Non-Invasive ventilation (NIV) is a life saving intervention for patients with acute respiratory failure (ARF). Some patients are not able to tolerate the NIV intervention and ultimately fail, requiring the use of invasive mechanical ventilation (IMV) and intubation. Sedation may improve a patient's NIV tolerance. However, this practice has not been adopted by intensivists as the risk of over-sedation resulting in respiratory depression, inability to protect the airway, and inadvertent need for intubation are all large deterrents of sedative use in NIV. The Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults: a Pragmatic Randomized Controlled Trial (inDEX) is looking to evaluate the effectiveness of dexmedetomidine compared to placebo in reducing non-invasive ventilation failures in patients admitted to the hospital with acute respiratory failure.
Trial Details
NCT Number NCT06259565
Lead Sponsor St. Joseph's Healthcare Hamilton
Collaborators: Population Health Research Institute
Conditions
(from sponsor)		 Non-Invasive Ventilation
Enrollment 846 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov