Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults: An International Pragmatic Randomized Controlled Trial (inDEX Trial)

4257

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.

2024-10-02

2025-01-02

2025-01-02

Not yet recruiting

Early phase I

826

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 (Appendix 1 Table 1): 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 feels the patient is intolerant of NIV or agitated, not captured above (all reasons will be recorded) Exclusion Criteria: 1. Bradycardia defined as: 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. Acute hepatic failure 4. Imminent need for endotracheal intubation 5. Death is deemed imminent and inevitable 6. Patients already on dexmedetomidine at time of enrolment 7. Known allergy to dexmedetomidine 8. Current pregnancy (should not breastfeed until 24 hours from discontinuation of medication) 9. Treating physician refuses enrolment (reasons for refusal will be captured) 10. Previously enrolled in the inDEX trial

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 826, 'type': 'ESTIMATED'}}

2024-04-19