Non-invasive Ventilation and Dex in Critically Ill Adults

• Status: Not yet recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

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 Vanguard 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. The results from this pilot trial, will subsequently inform a large, pragmatic, powered trial to definitively address the question.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Joseph's Healthcare Hamilton
• Collaborator: Hamilton Academic Health Sciences Organization
• Treatments: Dexmedetomidine

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

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)

2. Patient expresses intolerance or requests removal of NIV secondary to self-reported discomfort, anxiety, or claustrophobia

3. Other reason that the physician feels the patient is intolerant of NIV or agitated, not captured above (all reasons will be recorded)

Exclusion Criteria:

1. Absence of a functioning pacemaker with one of the following: a-Persistent bradycardia defined as a heart rate (HR) ≤50bpm; b-Second or third-degree heart block; or c- Tachybrady syndrome

2. Persistent hypotension, defined as a mean arterial pressure (MAP) ≤60mmHg despite volume resuscitation and vasopressors

3. Acute hepatic failure

4. Known allergy to dexmedetomidine

5. Pregnancy

6. Acute withdrawal from drugs or alcohol

7. Patients with post-extubation respiratory failure

8. Imminent need for endotracheal intubation

9. Death is deemed imminent and inevitable

10. Patient's goals of care do not include intubation and IMV

11. Patients already on dexmedetomidine at time of enrollment

12. Previously enrolled in the inDEX trial

13. Treating physician refuses enrollment (reasons for refusal will be captured)