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Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults
Sponsor: St. Joseph's Healthcare Hamilton
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.
Official title: Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults: An International Pragmatic Randomized Controlled Trial (inDEX Trial)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
846
Start Date
2025-07-29
Completion Date
2030-01-31
Last Updated
2025-09-10
Healthy Volunteers
No
Conditions
Interventions
Dexmedetomidine
Dexmedetomidine (Dex) is an α2-adrenergic agonist sedative commonly used in invasive mechanical ventilation (IMV) that promotes patient wakefulness, has no effect on respiratory drive, has important analgesic properties, and reduces delirium
Placebo Control
Those in the control group will receive a placebo that is identical in colour and packaging and at equal volume to the intervention group. Each bag of placebo contains 100mL of 0.9% sodium chloride and labeled as per Health Canada guidance for labelling pharmaceutical drugs for use in humans
Locations (6)
Fraser Health Authority
Surrey, British Columbia, Canada
Brockville General Hospital
Brockville, Ontario, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Juravinski Hospital and Cancer Centre
Hamilton, Ontario, Canada
North York General Hospital
Toronto, Ontario, Canada
Sinai Health System
Toronto, Ontario, Canada