Condition: Non-Invasive Ventilation · Sponsor: St. Joseph's Healthcare Hamilton
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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.
This description comes directly from the study's public registry record.
Kimberley Lewis, MD · (289)775-7334 · kimberley.lewis@medportal.ca
Jose Estrada · jestrada@stjosham.on.ca
There is no obligation to join — the study team can answer your questions about taking part.
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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)
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Fraser Health Authority | Surrey, British Columbia, Canada | Not Yet Recruiting |
| Brockville General Hospital | Brockville, Ontario, Canada | Not Yet Recruiting |
| St. Joseph's Healthcare Hamilton | Hamilton, Ontario, Canada | Recruiting |
| Juravinski Hospital and Cancer Centre | Hamilton, Ontario, Canada | Not Yet Recruiting |
| North York General Hospital | Toronto, Ontario, Canada | Not Yet Recruiting |
| Sinai Health System | Toronto, Ontario, Canada | Not Yet Recruiting |
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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