Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults

ConditionNon-Invasive Ventilation

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorSt. Joseph's Healthcare Hamilton

About this trial

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

Qualifiers

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

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

Dexmedetomidine
Placebo Control

Treatment groups

846 Participants

are divided into 2 treatment groups

Sponsors and collaborators

St. Joseph's Healthcare Hamilton

Lead sponsor

Population Health Research Institute

Collaborator

Source ClinicalTrials.gov