Actively Recruiting
Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults
Led by St. Joseph's Healthcare Hamilton · Updated on 2025-09-10
846
Participants Needed
6
Research Sites
235 weeks
Total Duration
On this page
Sponsors
S
St. Joseph's Healthcare Hamilton
Lead Sponsor
P
Population Health Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
-
Age ≥18 years
-
Patient receiving any NIV modality for acute respiratory failure of any etiology
-
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
-
Presence of one or more of the following after optimized NIV treatment:
- 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)
- Patient expresses intolerance or requests removal of NIV secondary to self-reported discomfort, anxiety, or claustrophobia
- 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.
You will not qualify if you...
- 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
- Persistent hypotension, defined as a mean arterial pressure (MAP) ≤65mmHg despite volume resuscitation and vasopressors
- Imminent need for endotracheal intubation as determined by healthcare team
- Patient's goals of care do not include intubation and IMV
- Patient is not for vasopressors or inotropic support
- Death is deemed imminent and inevitable
- Patient is currently on a dexmedetomidine infusion for a duration of > 12 hours
- Previously enrolled in the inDEX trial
- Acute liver failure with hepatic encephalopathy INR > 3 and/or bilirubin > 300
- Current pregnancy or breast feeding
- Known allergy to dexmedetomidine
- Patients receiving Amphotericin B or Diazepam
- Treating physician does not believe that participation in the trial is in the best interest of the patient (reasons for refusal will be captured)
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Fraser Health Authority
Surrey, British Columbia, Canada, V3T 0H1
Not Yet Recruiting
2
Brockville General Hospital
Brockville, Ontario, Canada, K6V 1S8
Not Yet Recruiting
3
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Actively Recruiting
4
Juravinski Hospital and Cancer Centre
Hamilton, Ontario, Canada, L8V 1C3
Not Yet Recruiting
5
North York General Hospital
Toronto, Ontario, Canada, M2K 1E1
Not Yet Recruiting
6
Sinai Health System
Toronto, Ontario, Canada, M5G 1X5
Not Yet Recruiting
Research Team
K
Kimberley Lewis, MD
CONTACT
J
Jose Estrada
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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