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)
NIV Failure — 28 days The primary outcome is NIV failure, defined by either mortality or intubation
Trial sites (6)
Facility
City
Region
Status
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
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.
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