Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults
Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults: An International Pragmatic Randomized Controlled Trial (inDEX Trial)
St. Joseph's Healthcare Hamilton
846 participants
Jul 29, 2025
INTERVENTIONAL
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
Inclusion Criteria7
- 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.
Exclusion Criteria13
- 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)
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Interventions
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
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06259565