Non-Invasive VentilationPhase 3inDEXNCT06259565
Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults
A Phase 3 study testing Dexmedetomidine in people with Non-Invasive Ventilation, run by St. Joseph's Healthcare Hamilton at 6 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Invasive Ventilation
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 846 participants
- Where
- 6 sitesCanada
- Study dates
- 29 Jul 2025to 31 Jan 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jose Estrada contact
6 sites in 1 country
Canada6 sites, 6 recruiting
- Not yet recruiting
Brockville General Hospital
Brockville, Ontario, K6V 1S8
Tommy Li, tli@brockvillegeneralhospital.ca
Mohammed Al-Amoudi, MD
- Recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Jose Estrada, 905-522-1155 Ext. 32873, jestrada@stjosham.on.ca
Irene Armanious, 905-522-1155 Ext. 32873, iarmanio@stjosham.on.ca
- Not yet recruiting
Juravinski Hospital and Cancer Centre
Hamilton, Ontario, L8V 1C3
Tina Millen, millent@mcmaster.ca
Bram Rochwerg, MD
- Not yet recruiting
Fraser Health Authority
Surrey, British Columbia, V3T 0H1
Patrick Altejos, patrick.altejos@fraserhealth.ca
Wesley Jang, MD
- Not yet recruiting
North York General Hospital
Toronto, Ontario, M2K 1E1
Mary Rahmat, mary.rahmat@nygh.on.ca
Anna Geaea, MD
- Not yet recruiting
Sinai Health System
Toronto, Ontario, M5G 1X5
Sumesh Shah, sumesh.shah@sinaihealth.ca
Geetha Mehta, MD
About this study
Official title: Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults: An International Pragmatic Randomized Controlled Trial (inDEX 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.
Read the detailed description
Acute respiratory failure (ARF) is a common reason for admission to an intensive care unit (ICU). Non-invasive positive pressure ventilation (NIV) is a life-saving intervention for selected patients with ARF. Compared to endotracheal intubation and invasive mechanical ventilation (IMV), NIV is safer, less invasive, preferred by most patients, and is associated with a reduced ICU length of stay (LOS), less pneumonia and mortality, and lower healthcare costs.
NIV failure can occur, necessitating IMV. Risk factors associated with NIV failure including intolerance, agitation, and delirium. Sedation is a potential solution for NIV intolerance, however the evidence is sparse and the risk of over-sedation resulting in respiratory depression, inability to protect the airway, and inadvertent need for intubation are all large deterrents.
Dexmedetomidine (Dex) is an α2-adrenergic agonist sedative commonly used in IMV that promotes patient wakefulness, has no effect on respiratory drive, has important analgesic properties, and reduces delirium. The investigators hypothesize that Dex, when compared to placebo, reduces NIV failure in hospitalized adults with ARF and agitation or NIV intolerance.
Overall Goal: To determine if Dex, compared to placebo, reduces the risk of NIV failure in patients that admitted to hospital with acute respiratory failure and are intolerant of NIV.
Target Population: 846 patients will be enrolled into the trial if they meet all the following criteria: 1) ≥18 years old; 2) Receiving any NIV modality for ARF 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: a) Agitation, b) Patient expresses intolerance or requests removal of NIV secondary to self-reported discomfort, anxiety, or claustrophobia, or c) Other reason that the physician feels the patient is intolerant of NIV or agitated not captured above, or feels that the patient will benefit from sedation (all reasons will be recorded).
Methods: The inDEX trial is a pragmatic, international, multi-centred, stratified, randomized, parallel-group, placebo-controlled trial. Patients, investigators, healthcare team, data collectors, outcome assessors, and the statistician will be blinded to trial arms. The trial will maximize external validity by including patients in a range of hospitals across the world. Patients randomized to the experimental arm will receive Dex while those randomized to the control arm will receive placebo.
Assessment: The primary outcome is NIV failure. The investigators define NIV failure as the proportion that require intubation or have died at 28 days.
- Conditions
- Non-Invasive Ventilation
- Being tested
- Dexmedetomidine, Placebo Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine (Dex) is an α2-adrenergic agonist sedative commonly used in invasive mechanical ventilation (IMV) that promotes patient wakefulness, has no effect on respiratory drive, has important analgesic properties, and reduces delirium
Placebo ControlOther
Those in the control group will receive a placebo that is identical in colour and packaging and at equal volume to the intervention group. Each bag of placebo contains 100mL of 0.9% sodium chloride and labeled as per Health Canada guidance for labelling pharmaceutical drugs for use in humans
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Intervention | Experimental | Dexmedetomidine (Dex) is an α2-adrenergic agonist sedative commonly used in IMV that promotes patient wakefulness, has no effect on respiratory drive, has important analgesic properties, and reduces delirium.
Patients randomized to the experimental arm will receive dexmedetomidine. At initiation, a bolus will NOT be administered. In keeping with Health Canada Guidelines, we will start the infusion at a mid-range dose of 0.5mcg/kg/h with titration either up or down by 0.1mcg/kg/h every 20-30 minutes to a maximum rate of 1.2mcg/kg/h to maintain light sedation (RASS = -2 to +1 or SAS 3-4). Each bag will be composed of composed of dexmedetomidine 4mcg/mL(in 0.9% sodium chloride) prepared as a volume of 100mL and labeled as per Health Canada guidance for labelling pharmaceutical drugs for use in humans. Receives: Drug: Dexmedetomidine |
| Placebo Control | Placebo comparator | Those in the control group will receive a placebo that is identical in colour and packaging and at equal volume to the intervention group. Each bag of placebo contains 100mL of 0.9% sodium chloride and labeled as per Health Canada guidance for labelling pharmaceutical drugs for use in humans Receives: Other: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIV Failure
The primary outcome is NIV failure, defined by either mortality or intubation
Measured: 28 days
Secondary outcomes (5)
Physiologic outcomes: Incidence of delirium
Delirium assessed using the ICU-CAM or ICDSC every 12 hours during NIV and daily thereafter until ICU discharge
Measured: 28 days
Physiologic outcomes: Incidence of agitation
Agitation defined as Richmond Agitation Sedation Scale (RASS) ≥2+ during NIV), where RASS scale ranges from -5 (unrousable) to +4 (combative).
Measured: 28 days
Major morbidity or mortality outcomes: Intubation
Intubation
Measured: 14 days
Major morbidity or mortality outcomes: ICU Mortality
ICU mortality
Measured: 28 days
Major morbidity or mortality outcomes: Hospital Mortality
Hospital Mortality
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start29 Jul 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Invasive VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients randomized to the experimental arm will receive dexmedetomidine. We will start the infusion at a mid-range dose of 0.5mcg/kg/h with titration either up or down by 0.1mcg/kg/h every 20-30 minutes to a maximum rate of 1.2mcg/kg/h to maintain light sedation (RASS = -2 to +1 or SAS = 3 to 4). The study drug will always be titrated to the lowest possible dose with preserved effect. Each bag will be composed of two 100 mcg/mL dexmedetomidine vials (2ml vials) mixed in a 96mL 0.9% sodium chloride mini-bag (4mcg/ml) and labeled as per Health Canada guidance for labelling pharmaceutical drugs for use in humans. The trial protocol does not allow an initial bolus of dexmedetomidine for safety reasons.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 846 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- Population Health Research Institute
- Responsible party
- Principal investigator, Kimberley Lewis, St. Joseph's Healthcare Hamilton
- Investigators
- Kimberley Lewis, MD, Principal investigator, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259565
- Sponsor's protocol ID
- 4257
- Acronym
- inDEX
- Status last verified
- Sep 2025
- First submitted
- 27 Dec 2023
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults: An International Pragmatic Randomized Controlled Trial (inDEX Trial)
- ClinicalTrials.gov ID
- NCT06259565
- Acronym / sponsor ID
- inDEX / 4257
- Conditions
- Non-Invasive Ventilation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 846 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- Population Health Research Institute
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Acute respiratory failure (ARF) is a common reason for admission to an intensive care unit (ICU). Non-invasive positive pressure ventilation (NIV) is a life-saving intervention for selected patients with ARF. Compared to endotracheal intubation and invasive mechanical ventilation (IMV), NIV is safer, less invasive, preferred by most patients, and is associated with a reduced ICU length of stay (LOS), less pneumonia and mortality, and lower healthcare costs.
NIV failure can occur, necessitating IMV. Risk factors associated with NIV failure including intolerance, agitation, and delirium. Sedation is a potential solution for NIV intolerance, however the evidence is sparse and the risk of over-sedation resulting in respiratory depression, inability to protect the airway, and inadvertent need for intubation are all large deterrents.
Dexmedetomidine (Dex) is an α2-adrenergic agonist sedative commonly used in IMV that promotes patient wakefulness, has no effect on respiratory drive, has important analgesic properties, and reduces delirium. The investigators hypothesize that Dex, when compared to placebo, reduces NIV failure in hospitalized adults with ARF and agitation or NIV intolerance.
Overall Goal: To determine if Dex, compared to placebo, reduces the risk of NIV failure in patients that admitted to hospital with acute respiratory failure and are intolerant of NIV.
Target Population: 846 patients will be enrolled into the trial if they meet all the following criteria: 1) ≥18 years old; 2) Receiving any NIV modality for ARF 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: a) Agitation, b) Patient expresses intolerance or requests removal of NIV secondary to self-reported discomfort, anxiety, or claustrophobia, or c) Other reason that the physician feels the patient is intolerant of NIV or agitated not captured above, or feels that the patient will benefit from sedation (all reasons will be recorded).
Methods: The inDEX trial is a pragmatic, international, multi-centred, stratified, randomized, parallel-group, placebo-controlled trial. Patients, investigators, healthcare team, data collectors, outcome assessors, and the statistician will be blinded to trial arms. The trial will maximize external validity by including patients in a range of hospitals across the world. Patients randomized to the experimental arm will receive Dex while those randomized to the control arm will receive placebo.
Assessment: The primary outcome is NIV failure. The investigators define NIV failure as the proportion that require intubation or have died at 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients randomized to the experimental arm will receive dexmedetomidine. We will start the infusion at a mid-range dose of 0.5mcg/kg/h with titration either up or down by 0.1mcg/kg/h every 20-30 minutes to a maximum rate of 1.2mcg/kg/h to maintain light sedation (RASS = -2 to +1 or SAS = 3 to 4). The study drug will always be titrated to the lowest possible dose with preserved effect. Each bag will be composed of two 100 mcg/mL dexmedetomidine vials (2ml vials) mixed in a 96mL 0.9% sodium chloride mini-bag (4mcg/ml) and labeled as per Health Canada guidance for labelling pharmaceutical drugs for use in humans. The trial protocol does not allow an initial bolus of dexmedetomidine for safety reasons.
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Intervention | Experimental | Drug: DexmedetomidineDexmedetomidine (Dex) is an α2-adrenergic agonist sedative commonly used in IMV that promotes patient wakefulness, has no effect on respiratory drive, has important analgesic properties, and reduces delirium. Patients randomized to the experimental arm will receive dexmedetomidine. At initiation, a bolus will NOT be administered. In keeping with Health Canada Guidelines, we will start the infusion at a mid-range dose of 0.5mcg/kg/h with titration either up or down by 0.1mcg/kg/h every 20-30 minutes to a maximum rate of 1.2mcg/kg/h to maintain light sedation (RASS = -2 to +1 or SAS 3-4). Each bag will be composed of composed of dexmedetomidine 4mcg/mL(in 0.9% sodium chloride) prepared as a volume of 100mL and labeled as per Health Canada guidance for labelling pharmaceutical drugs for use in humans. |
| Placebo Control | Placebo comparator | Other: Placebo ControlThose in the control group will receive a placebo that is identical in colour and packaging and at equal volume to the intervention group. Each bag of placebo contains 100mL of 0.9% sodium chloride and labeled as per Health Canada guidance for labelling pharmaceutical drugs for use in humans |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Presence of one or more of the following after optimized NIV treatment:
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineDexmedetomidine (Dex) is an α2-adrenergic agonist sedative commonly used in invasive mechanical ventilation (IMV) that promotes patient wakefulness, has no effect on respiratory drive, has important analgesic properties, and reduces delirium | Drug | Dexmedetomidine Intervention |
| Placebo ControlThose in the control group will receive a placebo that is identical in colour and packaging and at equal volume to the intervention group. Each bag of placebo contains 100mL of 0.9% sodium chloride and labeled as per Health Canada guidance for labelling pharmaceutical drugs for use in humans | Other | Placebo Control |
Primary outcome
NIV Failure
Time frame: 28 days
The primary outcome is NIV failure, defined by either mortality or intubation
5 secondary outcomes
Physiologic outcomes: Incidence of delirium
Time frame: 28 days
Physiologic outcomes: Incidence of agitation
Time frame: 28 days
Major morbidity or mortality outcomes: Intubation
Time frame: 14 days
Major morbidity or mortality outcomes: ICU Mortality
Time frame: 28 days
Major morbidity or mortality outcomes: Hospital Mortality
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jose Estrada contact
Kimberley Lewis, MD principal investigator
St. Joseph's Healthcare Hamilton
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine in people with Non-Invasive Ventilation, run by St. Joseph's Healthcare Hamilton at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimberley Lewis, MD ((289)775-7334, kimberley.lewis@medportal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIV Failure (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.