Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06259565
PHASE3

Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults

Sponsor: St. Joseph's Healthcare Hamilton

View on ClinicalTrials.gov

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

Interventions

DRUG

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

OTHER

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