Respiratory InsufficiencyPhase 3inDEXNCT04878510
Non-invasive Ventilation and Dex in Critically Ill Adults
A Phase 3 study testing Dexmedetomidine in people with Respiratory Insufficiency, run by St. Joseph's Healthcare Hamilton at 3 sites in 3 countries.
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
- Respiratory Insufficiency
- 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
- 24 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 7 Mar 2022to 21 Apr 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- 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)
- Patient expresses intolerance or requests removal of NIV secondary to self-reported discomfort, anxiety, or claustrophobia
- Other reason that the physician feels the patient is intolerant of NIV or agitated, not captured above (all reasons will be recorded)
Who cannot join
- Absence of a functioning pacemaker with one of the following: a-Persistent bradycardia defined as a heart rate (HR) ≤50bpm; b-Second or third-degree heart block; or c- Tachybrady syndrome
- Persistent hypotension, defined as a mean arterial pressure (MAP) ≤60mmHg despite volume resuscitation and vasopressors
- Acute hepatic failure
- Known allergy to dexmedetomidine
- Pregnancy
- Acute withdrawal from drugs or alcohol
Show all 13Show fewer
- Patients with post-extubation respiratory failure
- Imminent need for endotracheal intubation
- Death is deemed imminent and inevitable
- Patient's goals of care do not include intubation and IMV
- Patients already on dexmedetomidine at time of enrollment
- Previously enrolled in the inDEX trial
- Treating physician refuses enrollment (reasons for refusal will be captured)
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults: a Vanguard 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 Vanguard 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. The results from this pilot trial, will subsequently inform a large, pragmatic, powered trial to definitively address the question.
Read the detailed description
- BACKGROUND: Non-invasive ventilation (NIV) is a life-saving intervention for patients with acute respiratory failure (ARF). Patients may find NIV intolerable and ultimately fail NIV requiring intubation and invasive mechanical ventilation (IMV). 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. Current guidelines lack recommendations on which sedative, if any at all, should be used during NIV due to the paucity of reliable data. Dexmedetomidine (dex) is a relatively new sedative. It promotes patient wakefulness, has no effect on respiratory drive, has important analgesic properties, and when compared to γ-aminobutyric acid receptor agonists like benzodiazepines, reduces delirium. Dex has been recommended to use over benzodiazepines for sedation during IMV in critically ill adults, particularly if delirium is precluding weaning.
- HYPOTHESIS: We hypothesize that dexmedetomidine, when compared to placebo, reduces NIV failure in hospitalized adults with acute respiratory failure and agitation or NIV intolerance.
- OBJECTIVES: To evaluate the feasibility of assessing if dexmedetomidine compared to placebo results in a reduction of non-invasive ventilation failure in patients admitted to the hospital with acute respiratory failure. This will subsequently inform a large, pragmatic, powered trial to definitively address the question.
- METHODS
4.1 Study design: The inDEX trial is a pragmatic, international, multi-centered, stratified, randomized, parallel-group, double-blind, placebo-controlled vanguard trial. Patients, investigators, healthcare team, data collectors, outcome assessors, and the statistician will be blinded to trial arms.
4.2 Allocation and randomization: Local Research Coordinators (RC) will randomize eligible patients in a fixed 1:1 allocation using undisclosed variable block sizes of four, six, or eight. The randomization will be achieved using a random number sequence prepared by an independent statistician. The independent statistician will have access to the random number sequence and it will be provided to the research pharmacist. Upon request by the local research coordinator, the research pharmacist will provide the care team with either placebo or dexmedetomidine, according to the randomization schedule. 4.3 Blinding: Both dexmedetomidine and normal saline placebo will be given as continuous infusion. To minimize performance and ascertainment biases, and maintain blinding of patients, investigators, clinical staff, and RCs; a Research Pharmacist, who is not involved in assessment of patient outcomes or patient care, will prepare infusion bags. Titration of the infusion rate for both arms will follow an identical volume-based titration algorithm. Despite optimal blinding efforts, it is possible that the care team may be able to determine who is receiving dexmedetomidine based on improvement in NIV tolerance and/or the decrease in heart rate and blood pressure. However, the cointerventions may also improve tolerance, and can certainly cause a reduction in heart rate and blood pressure.
- Conditions
- Respiratory Insufficiency
- Being tested
- Dexmedetomidine, Placebo
- Keywords
- Non-Invasive Ventilation, Sedation, Randomized Control Trial, Acute Respiratory Failure
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
Dexmedetomidine is an α2-adrenergic agonist sedative commonly used in invasive mechanical ventilation that promotes patient wakefulness, has no effect on respiratory drive, has important analgesic properties, and when compared to γ-aminobutyric acid receptor agonists like benzodiazepines, reduces delirium.
PlaceboOther
Normal saline placebo will be given as continuous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Intervention | Experimental | Patients randomized to the experimental arm will receive dexmedetomidine. At initiation, a bolus will NOT be administered. In keeping with Health Canada. Guidelines, the infusion will start at a mid-range dose of 0.6mcg/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 (Richmond Agitation-Sedation Scale [RASS] = -2 to +1 or Riker Sedation-Agitation Scale [SAS] 3-4). Receives: Drug: Dexmedetomidine |
| Control Intervention | 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 50mL of 0.9% sodium chloride and labeled as per Health Canada guidance for labelling pharmaceutical drugs for use in humans. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
The rate in which patients are enrolled, by calculating the mean number of recruited patients compared to the number of patients screened.
Measured: At the completion of the trial (approximately 1 year).
Protocol Adherence; Proportion of patients assigned to the experimental arm that received the intervention and those assigned to the control arm that did not receive the intervention.
Adherence will be calculated as the proportion of patients assigned to the experimental arm that received the intervention and those assigned to the control arm that did not receive the intervention.
Measured: At the completion of the trial (approximately 1 year).
Consent Rate
The consent rate will be calculated as the overall proportion of substitute decision makers or patients who consented to be enrolled out of those approached.
Measured: At the completion of the trial (approximately 1 year).
Secondary outcomes (20)
Acute care unit outcomes; Non-invasive ventilation (NIV) failure
Number of participants with NIV failure defined as the patients undergoing invasive mechanical ventilation within 28-post randomization.
Measured: 28 days post-randomization.
Acute care unit outcomes; Acute Care Unite Length of Stay
Acute Care Unite Length of Stay is defined as the number of days the patient is admitted to an Acute Care Unit while admitted to the hospital.
Measured: 60 days post-randomization.
Acute care unit outcomes; Duration of invasive mechanical ventilation
Duration of invasive mechanical ventilation during hospital stay is defined as the number of days the patient received invasive mechanical ventilation at 60 days post-randomization.
Measured: 60 days post-randomization.
Acute care unit outcomes; Ventilation free Days
Ventilation free days is defined as the number of days the patient did not receive and ventilation during hospital stay truncated at 28 days (either invasive mechanical ventilation or NIV).
Measured: 28 days post-randomization.
Process Outcomes; Number of patient-initiated device removal episodes.
Number of patient-initiated device removal episodes will be defined as the number of times a patient attempts to remove their device while receiving NIV.
Measured: 4 days post-randomization.
Process Outcomes; Richmond-Agitation Sedation Scale (RASS) measurements
The proportion of RASS measurements in target range while on the trial drugs while receiving NIV.
Measured: 4 days post-randomization.
Process Outcomes; The mean NIV tolerance score.
The mean NIV tolerance score will be defined as the proportion of tolerance scores that indicate that the patient is comfortable and relaxed while receiving NIV.
Measured: 4 days post-randomization.
Process Outcomes; Days spent with delirium
Days spent with delirium will be defined as the number of days that the patient experienced delirium during and after receiving NIV while admitted to the hospital.
Measured: 28 days post-randomization.
Process Outcomes; Cointerventions
The use and dose of any cointerventions (i.e. benzodiazepines, opioids, and antipsychotics) during NIV treatment.
Measured: 4 days post-randomization.
Hospital Outcomes; Hospital length of stay
Hospital Length of stay is defined at the total number of days the patient spent in the hospital.
Measured: 60 days post-randomization.
Hospital Outcomes; Mortality
Mortality is defined at the number of deaths that occur between randomization and 60-Day post-randomization.
Measured: 60 days post-randomization.
Adverse Events: Bradycardia
Adverse events will be defined as; bradycardia (heart rate <60 bpm).
Measured: 60 Days post-randomization
Adverse Events: Severe bradycardia
Adverse events will be defined as; severe bradycardia (heart rate <50 bpm).
Measured: 60 Days post-randomization
Adverse Events: Clinically significant bradycardia
Adverse events will be defined as; clinically significant bradycardia (bradycardia requiring inotropes, vasopressors, external pacing, temporary pacemaker, or discontinuation of the trial medication).
Measured: 60 Days post-randomization
Adverse Events: hypotension
Adverse events will be defined as; hypotension (mean arterial pressure < 60mmHg, or >20mmHg below admission baseline).
Measured: 60 Days post-randomization
Adverse Events: clinically significant hypotension
Adverse events will be defined as; clinically significant hypotension (hypotension requiring vasopressors, fluid administration, or discontinuation of the trial medication).
Measured: 60 Days post-randomization
Adverse Events: hypertension
Adverse events will be defined as; hypertension (a systolic blood pressure >180mmHg or a diastolic blood pressure >110mmHg).
Measured: 60 Days post-randomization
Adverse Events: Cardiac Arrest
Adverse events will be defined as; cardiac arrest.
Measured: 60 Days post-randomization
Functional Outcomes; quality of life
Functional Outcomes will be defined as; quality of life outcomes will be collected using the EQ-5D-5L questionnaire at pre-hospital, baseline, 28-Days and 60-Days post-randomization.
Measured: 60 Days post-randomization
Functional Outcomes; clinical frailty
Functional Outcomes will be defined as the "clinical frailty score" will be collected at pre-hospital, baseline, 28-Days and 60-Days post-randomization.
Measured: 60 Days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start7 Mar 2022
- Primary completion21 Apr 2024
- Study completion21 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies 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
- The inDEX trial is a pragmatic, international, multi-centered, stratified, randomized, parallel-group, double-blind, placebo-controlled vanguard trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberley Lewis, St. Joseph's Healthcare Hamilton
- Investigators
- Kimberley Lewis, MD, Principal investigator, Research Institute of St Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878510
- Sponsor's protocol ID
- 13205
- Acronym
- inDEX
- Status last verified
- Oct 2024
- First submitted
- 25 Apr 2021
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults: a Vanguard Pragmatic Randomized Controlled Trial (inDEX Trial)
- ClinicalTrials.gov ID
- NCT04878510
- Acronym / sponsor ID
- inDEX / 13205
- Conditions
- Respiratory Insufficiency
- Keywords
- Non-Invasive Ventilation, Sedation, Randomized Control Trial, Acute Respiratory Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 21 Apr 2024 (actual)
- Study completion
- 21 Apr 2024 (actual)
- First posted
- 7 May 2021 (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 Vanguard 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. The results from this pilot trial, will subsequently inform a large, pragmatic, powered trial to definitively address the question.
Detailed description
- BACKGROUND: Non-invasive ventilation (NIV) is a life-saving intervention for patients with acute respiratory failure (ARF). Patients may find NIV intolerable and ultimately fail NIV requiring intubation and invasive mechanical ventilation (IMV). 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. Current guidelines lack recommendations on which sedative, if any at all, should be used during NIV due to the paucity of reliable data. Dexmedetomidine (dex) is a relatively new sedative. It promotes patient wakefulness, has no effect on respiratory drive, has important analgesic properties, and when compared to γ-aminobutyric acid receptor agonists like benzodiazepines, reduces delirium. Dex has been recommended to use over benzodiazepines for sedation during IMV in critically ill adults, particularly if delirium is precluding weaning.
- HYPOTHESIS: We hypothesize that dexmedetomidine, when compared to placebo, reduces NIV failure in hospitalized adults with acute respiratory failure and agitation or NIV intolerance.
- OBJECTIVES: To evaluate the feasibility of assessing if dexmedetomidine compared to placebo results in a reduction of non-invasive ventilation failure in patients admitted to the hospital with acute respiratory failure. This will subsequently inform a large, pragmatic, powered trial to definitively address the question.
- METHODS
4.1 Study design: The inDEX trial is a pragmatic, international, multi-centered, stratified, randomized, parallel-group, double-blind, placebo-controlled vanguard trial. Patients, investigators, healthcare team, data collectors, outcome assessors, and the statistician will be blinded to trial arms.
4.2 Allocation and randomization: Local Research Coordinators (RC) will randomize eligible patients in a fixed 1:1 allocation using undisclosed variable block sizes of four, six, or eight. The randomization will be achieved using a random number sequence prepared by an independent statistician. The independent statistician will have access to the random number sequence and it will be provided to the research pharmacist. Upon request by the local research coordinator, the research pharmacist will provide the care team with either placebo or dexmedetomidine, according to the randomization schedule. 4.3 Blinding: Both dexmedetomidine and normal saline placebo will be given as continuous infusion. To minimize performance and ascertainment biases, and maintain blinding of patients, investigators, clinical staff, and RCs; a Research Pharmacist, who is not involved in assessment of patient outcomes or patient care, will prepare infusion bags. Titration of the infusion rate for both arms will follow an identical volume-based titration algorithm. Despite optimal blinding efforts, it is possible that the care team may be able to determine who is receiving dexmedetomidine based on improvement in NIV tolerance and/or the decrease in heart rate and blood pressure. However, the cointerventions may also improve tolerance, and can certainly cause a reduction in heart rate and blood pressure.
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
- The inDEX trial is a pragmatic, international, multi-centered, stratified, randomized, parallel-group, double-blind, placebo-controlled vanguard trial.
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Intervention | Experimental | Drug: DexmedetomidinePatients randomized to the experimental arm will receive dexmedetomidine. At initiation, a bolus will NOT be administered. In keeping with Health Canada. Guidelines, the infusion will start at a mid-range dose of 0.6mcg/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 (Richmond Agitation-Sedation Scale [RASS] = -2 to +1 or Riker Sedation-Agitation Scale [SAS] 3-4). |
| Control Intervention | Placebo comparator | Other: PlaceboThose 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 50mL 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
- 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) ≤50bpm; b-Second or third-degree heart block; or c- Tachybrady syndrome
- Persistent hypotension, defined as a mean arterial pressure (MAP) ≤60mmHg despite volume resuscitation and vasopressors
- Acute hepatic failure
- Known allergy to dexmedetomidine
- Pregnancy
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 |
|---|---|---|
| DexmedetomidineAlso: PrecedexDexmedetomidine is an α2-adrenergic agonist sedative commonly used in invasive mechanical ventilation that promotes patient wakefulness, has no effect on respiratory drive, has important analgesic properties, and when compared to γ-aminobutyric acid receptor agonists like benzodiazepines, reduces delirium. | Drug | Dexmedetomidine Intervention |
| PlaceboNormal saline placebo will be given as continuous infusion. | Other | Control Intervention |
Primary outcome
Recruitment Rate
Time frame: At the completion of the trial (approximately 1 year).
The rate in which patients are enrolled, by calculating the mean number of recruited patients compared to the number of patients screened.
Protocol Adherence; Proportion of patients assigned to the experimental arm that received the intervention and those assigned to the control arm that did not receive the intervention.
Time frame: At the completion of the trial (approximately 1 year).
Adherence will be calculated as the proportion of patients assigned to the experimental arm that received the intervention and those assigned to the control arm that did not receive the intervention.
Consent Rate
Time frame: At the completion of the trial (approximately 1 year).
The consent rate will be calculated as the overall proportion of substitute decision makers or patients who consented to be enrolled out of those approached.
20 secondary outcomes
Acute care unit outcomes; Non-invasive ventilation (NIV) failure
Time frame: 28 days post-randomization.
Acute care unit outcomes; Acute Care Unite Length of Stay
Time frame: 60 days post-randomization.
Acute care unit outcomes; Duration of invasive mechanical ventilation
Time frame: 60 days post-randomization.
Acute care unit outcomes; Ventilation free Days
Time frame: 28 days post-randomization.
Process Outcomes; Number of patient-initiated device removal episodes.
Time frame: 4 days post-randomization.
Process Outcomes; Richmond-Agitation Sedation Scale (RASS) measurements
Time frame: 4 days post-randomization.
Process Outcomes; The mean NIV tolerance score.
Time frame: 4 days post-randomization.
Process Outcomes; Days spent with delirium
Time frame: 28 days post-randomization.
Process Outcomes; Cointerventions
Time frame: 4 days post-randomization.
Hospital Outcomes; Hospital length of stay
Time frame: 60 days post-randomization.
Hospital Outcomes; Mortality
Time frame: 60 days post-randomization.
Adverse Events: Bradycardia
Time frame: 60 Days post-randomization
Adverse Events: Severe bradycardia
Time frame: 60 Days post-randomization
Adverse Events: Clinically significant bradycardia
Time frame: 60 Days post-randomization
Adverse Events: hypotension
Time frame: 60 Days post-randomization
Adverse Events: clinically significant hypotension
Time frame: 60 Days post-randomization
Adverse Events: hypertension
Time frame: 60 Days post-randomization
Adverse Events: Cardiac Arrest
Time frame: 60 Days post-randomization
Functional Outcomes; quality of life
Time frame: 60 Days post-randomization
Functional Outcomes; clinical frailty
Time frame: 60 Days post-randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Kimberley Lewis, MD principal investigator
Research Institute of St Joseph's Healthcare Hamilton
3 sites in 3 countries: 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 Respiratory Insufficiency, run by St. Joseph's Healthcare Hamilton at 3 sites in 3 countries.
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: finished, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, Canada, Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: At the completion of the trial (approximately 1 year).). The study lists 3 primary outcomes in all. 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 28 Oct 2024.