Status:
COMPLETED
Non-invasive Ventilation and Dex in Critically Ill Adults
Lead Sponsor:
St. Joseph's Healthcare Hamilton
Conditions:
Respiratory Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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, requiri...
Detailed Description
1. BACKGROUND: Non-invasive ventilation (NIV) is a life-saving intervention for patients with acute respiratory failure (ARF). Patients may find NIV intolerable and ultimately fail NIV requiring i...
Eligibility Criteria
Inclusion
- 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
- 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)
- Patient expresses intolerance or requests removal of NIV secondary to self-reported discomfort, anxiety, or claustrophobia
- Other reason that the physician feels the patient is intolerant of NIV or agitated, not captured above (all reasons will be recorded)
Exclusion
- 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
- Persistent hypotension, defined as a mean arterial pressure (MAP) ≤60mmHg despite volume resuscitation and vasopressors
- Acute hepatic failure
- Known allergy to dexmedetomidine
- Pregnancy
- Acute withdrawal from drugs or alcohol
- Patients with post-extubation respiratory failure
- Imminent need for endotracheal intubation
- Death is deemed imminent and inevitable
- Patient's goals of care do not include intubation and IMV
- Patients already on dexmedetomidine at time of enrollment
- Previously enrolled in the inDEX trial
- Treating physician refuses enrollment (reasons for refusal will be captured)
Key Trial Info
Start Date :
March 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04878510
Start Date
March 7 2022
End Date
April 21 2024
Last Update
October 28 2024
Active Locations (3)
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1
Monash Medical Centre - Monash Health
Melbourne, Australia
2
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N4A6
3
King Abdulaziz Medical City - Riyadh
Riyadh, Saudi Arabia