Clinical Trial

Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults

Study acronym: inDEX
Recruiting Phase 3
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Summary
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2024-02-06; most recent amendment 2025-09-03.
Status change: Not Yet Recruiting → Recruiting 2025-07-30
Trial Details
NCT Number NCT06259565
Lead Sponsor St. Joseph's Healthcare Hamilton
Collaborators: Population Health Research Institute
Conditions Non-Invasive Ventilation
Enrollment 846 participants
Start Date 2025-07-29
Primary Completion 2029-12-31 (estimated)
Study Completion 2030-01-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-10