Dexmedetomidine to help adults tolerate non-invasive ventilation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 3, randomized, placebo-controlled trial comparing dexmedetomidine versus placebo in adults receiving non-invasive ventilation (NIV) who are agitated or intolerant of NIV. About 846 participants aged 18 or older will be enrolled at monitored hospital sites and randomized to receive titrated dexmedetomidine or placebo while on NIV. The primary outcome is NIV failure leading to invasive mechanical ventilation (intubation); secondary outcomes include measures of tolerance, delirium, and ICU length of stay. The trial tests whether dexmedetomidine's sedative and anti-delirium properties, with minimal respiratory depression, reduce the need for intubation.

Why it matters

Who can join: the full rules

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)

Where it's running

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

Study contacts

• Principal investigator: Kimberley Lewis, MD — St. Joseph's Healthcare Hamilton
• Study coordinator: Kimberley Lewis, MD
• Email: kimberley.lewis@medportal.ca
• Phone: (289)775-7334

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.