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Clinical Trials in Canada / NCT06259565
Recruiting Phase 3

Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults

NCT06259565 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2025-07-29
Last updated
2025-09-10

Condition(s) studied

Non-Invasive Ventilation

Investigational drug(s) / intervention(s)

Dexmedetomidine →Placebo Control

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥18 years 2. Patient receiving any NIV modality for acute respiratory failure of any etiology 3. Admitted to ICU, PACU, step-down unit (surgical or medical), or emergency department(with planned admission to a monitored setting) or equivalent unit where hemodynamics and respiratory status can be monitored, and NIV is permitted; and 4. Presence of one or more of the following after optimized NIV treatment: 1. Agitation (Defined as a Richmond Agitation and Sedation Scale \[RASS\] score of ≥+2 or a Riker Sedation-Agitation Scale \[SAS\] score of ≥5) (Appendix 1 Table 2 and Table 3) 2. Patient expresses intolerance or requests removal of NIV secondary to self-reported discomfort, anxiety, or claustrophobia 3. Other reason that the physician judges the patient to be intolerant of NIV or agitated, not captured above, or feels that the patient would benefit from titrated sedation for other reasons. Exclusion Criteria: 1. Absence of a functioning pacemaker with one of the following: a-Persistent bradycardia defined as a heart rate (HR) ≤60bpm; b-Second or third-degree heart block; or c- Tachybrady syndrome 2. Persistent hypotension, defined as a mean arterial pressure (MAP) ≤65mmHg despite volume resuscitation and vasopressors 3. Imminent need for endotracheal intubation as determined by healthcare team 4. Patient's goals of care do not include intubation and IMV 5. Patient is not for vasopressors or inotropic support 6. Death is deemed imminent and inevitable 7. Patient is currently on a dexmedetomidine infusion for a duration of \> 12 hours 8. Previously enrolled in the inDEX trial 9. Acute liver failure with hepatic encephalopathy INR \> 3 and/or bilirubin \> 300 10. Current pregnancy or breast feeding 11. Known allergy to dexmedetomidine 12. Patients receiving Amphotericin B or Diazepam 13. Treating physician does not believe that participation in the trial is in the best interest of the patient (reasons for refusal will be captured)

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Fraser Health Authority Surrey British Columbia Not Yet Recruiting
Brockville General Hospital Brockville Ontario Not Yet Recruiting
St. Joseph's Healthcare Hamilton Hamilton Ontario Recruiting
Juravinski Hospital and Cancer Centre Hamilton Ontario Not Yet Recruiting
North York General Hospital Toronto Ontario Not Yet Recruiting
Sinai Health System Toronto Ontario Not Yet Recruiting

More St. Joseph's Healthcare Hamilton trials in Canada

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06259565 on ClinicalTrials.gov ↗ ← All trials in Canada