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New treatment option for Non-Invasive Ventilation
Official title Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults
ClinicalTrials.gov ID: NCT06259565
What this study is testing
What is Dexmedetomidine?
Dexmedetomidine is an investigational medicine, being studied as a potential treatment for non-invasive ventilation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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) (Appendix 1...
You likely can't join if
- 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...
- 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
- Patient is not for vasopressors or inotropic support
- Death is deemed imminent and inevitable
See the full eligibility criteria
- 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...
- 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) (Appendix 1 Table 2 and Table 3)
- Patient expresses intolerance or requests removal of NIV secondary to self-reported discomfort, anxiety, or claustrophobia
- 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.
- 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
- Patient is not for vasopressors or inotropic support
- Death is deemed imminent and inevitable
- Patient is currently on a dexmedetomidine infusion for a duration of \> 12 hours
- Previously enrolled in the inDEX trial
- Acute liver failure with hepatic encephalopathy INR \> 3 and/or bilirubin \> 300
- Current pregnancy or breast feeding
- Known allergy to dexmedetomidine
- Patients receiving Amphotericin B or Diazepam
- Treating physician does not believe that participation in the trial is in the best interest of the patient (reasons for refusal will be captured)
The study team makes the final eligibility decision.
Where it's taking place
- Surrey, British Columbia, Canada
- Brockville, Ontario, Canada
- Hamilton, Ontario, Canada
- Toronto, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Surrey, British Columbia, Canada; Brockville, Ontario, Canada; Hamilton, Ontario, Canada; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.