NCT06259565 Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults
| NCT ID | NCT06259565 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | St. Joseph's Healthcare Hamilton |
| Condition | Non-Invasive Ventilation |
| Study Type | INTERVENTIONAL |
| Enrollment | 846 participants |
| Start Date | 2025-07-29 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 846 participants in total. It began in 2025-07-29 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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)
Contact & Investigator
Kimberley Lewis, MD
PRINCIPAL INVESTIGATOR
St. Joseph's Healthcare Hamilton
Frequently Asked Questions
Who can join the NCT06259565 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-Invasive Ventilation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06259565 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 846 participants.
Is NCT06259565 currently recruiting?
Yes, NCT06259565 is actively recruiting participants. Contact the research team at kimberley.lewis@medportal.ca for enrollment information.
Where is the NCT06259565 trial being conducted?
This trial is being conducted at Surrey, Canada, Brockville, Canada, Hamilton, Canada, Hamilton, Canada and 2 additional locations.
Who is sponsoring the NCT06259565 clinical trial?
NCT06259565 is sponsored by St. Joseph's Healthcare Hamilton. The principal investigator is Kimberley Lewis, MD at St. Joseph's Healthcare Hamilton. The trial plans to enroll 846 participants.