Can a sedative keep patients off ventilators? major trial underway
NCT ID NCT06259565
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests whether the sedative dexmedetomidine can help critically ill patients tolerate non-invasive ventilation (a mask that helps breathing) and avoid needing a breathing tube. About 846 adults with acute respiratory failure will receive either the drug or a placebo. The goal is to see if the drug reduces deaths or the need for intubation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dexmedetomidine (a sedative drug)
- What this could lead to
- If it works, this could provide a safe way to sedate patients on non-invasive ventilation, reducing the need for intubation and invasive breathing machines.
- What could go wrong
- This is a large Phase 3 trial, but sedation carries risks like respiratory depression or airway loss. The drug may not reduce failure rates compared to placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 846 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jan 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Brockville General Hospital
NOT_YET_RECRUITINGBrockville, Ontario, K6V 1S8, Canada
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Fraser Health Authority
NOT_YET_RECRUITINGSurrey, British Columbia, V3T 0H1, Canada
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Juravinski Hospital and Cancer Centre
NOT_YET_RECRUITINGHamilton, Ontario, L8V 1C3, Canada
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North York General Hospital
NOT_YET_RECRUITINGToronto, Ontario, M2K 1E1, Canada
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Sinai Health System
NOT_YET_RECRUITINGToronto, Ontario, M5G 1X5, Canada
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St. Joseph's Healthcare Hamilton
RECRUITINGHamilton, Ontario, L8N 4A6, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A global effort to make moving critically ill patients safer
- Healing together: could a Couples-Based program ease ICU aftermath?
- Are ventilated patients starving in silence? a new study investigates
- Can home ventilation help kids sleep better and live fuller lives?
- Can a simple inhaled combo keep pneumonia patients off ventilators?
- Can a Diaphragm-Sensing ventilator mode reduce breathing asynchrony?