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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04878510
Registration number
NCT04878510
Ethics application status
Date submitted
25/04/2021
Date registered
7/05/2021
Date last updated
28/02/2024
Titles & IDs
Public title
Non-invasive Ventilation and Dex in Critically Ill Adults
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Scientific title
Non-invasive Ventilation and Dexmedetomidine in Critically Ill Adults: a Vanguard Pragmatic Randomized Controlled Trial (inDEX Trial)
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Secondary ID [1]
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13205
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Universal Trial Number (UTN)
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Trial acronym
inDEX
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Respiratory Insufficiency
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Dexmedetomidine
Other interventions - Placebo
Experimental: Dexmedetomidine Intervention - 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).
Placebo Comparator: Control Intervention - 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.
Treatment: Drugs: Dexmedetomidine
Dexmedetomidine is an a2-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 ?-aminobutyric acid receptor agonists like benzodiazepines, reduces delirium.
Other interventions: Placebo
Normal saline placebo will be given as continuous infusion.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Recruitment Rate
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Assessment method [1]
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The rate in which patients are enrolled, by calculating the mean number of recruited patients compared to the number of patients screened.
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Timepoint [1]
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At the completion of the trial (approximately 1 year).
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Primary outcome [2]
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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.
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Assessment method [2]
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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.
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Timepoint [2]
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At the completion of the trial (approximately 1 year).
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Primary outcome [3]
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Consent Rate
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Assessment method [3]
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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.
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Timepoint [3]
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At the completion of the trial (approximately 1 year).
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Secondary outcome [1]
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Acute care unit outcomes; Non-invasive ventilation (NIV) failure
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Assessment method [1]
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Number of participants with NIV failure defined as the patients undergoing invasive mechanical ventilation within 28-post randomization.
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Timepoint [1]
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28 days post-randomization.
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Secondary outcome [2]
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Acute care unit outcomes; Acute Care Unite Length of Stay
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Assessment method [2]
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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.
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Timepoint [2]
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60 days post-randomization.
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Secondary outcome [3]
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Acute care unit outcomes; Duration of invasive mechanical ventilation
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Assessment method [3]
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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.
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Timepoint [3]
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60 days post-randomization.
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Secondary outcome [4]
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Acute care unit outcomes; Ventilation free Days
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Assessment method [4]
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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).
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Timepoint [4]
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28 days post-randomization.
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Secondary outcome [5]
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Process Outcomes; Number of patient-initiated device removal episodes.
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Assessment method [5]
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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.
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Timepoint [5]
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4 days post-randomization.
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Secondary outcome [6]
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Process Outcomes; Richmond-Agitation Sedation Scale (RASS) measurements
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Assessment method [6]
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The proportion of RASS measurements in target range while on the trial drugs while receiving NIV.
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Timepoint [6]
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4 days post-randomization.
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Secondary outcome [7]
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Process Outcomes; The mean NIV tolerance score.
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Assessment method [7]
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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.
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Timepoint [7]
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4 days post-randomization.
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Secondary outcome [8]
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Process Outcomes; Days spent with delirium
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Assessment method [8]
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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.
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Timepoint [8]
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28 days post-randomization.
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Secondary outcome [9]
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Process Outcomes; Cointerventions
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Assessment method [9]
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The use and dose of any cointerventions (i.e. benzodiazepines, opioids, and antipsychotics) during NIV treatment.
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Timepoint [9]
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4 days post-randomization.
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Secondary outcome [10]
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Hospital Outcomes; Hospital length of stay
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Assessment method [10]
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Hospital Length of stay is defined at the total number of days the patient spent in the hospital.
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Timepoint [10]
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60 days post-randomization.
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Secondary outcome [11]
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Hospital Outcomes; Mortality
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Assessment method [11]
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Mortality is defined at the number of deaths that occur between randomization and 60-Day post-randomization.
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Timepoint [11]
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60 days post-randomization.
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Secondary outcome [12]
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Adverse Events: Bradycardia
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Assessment method [12]
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Adverse events will be defined as; bradycardia (heart rate <60 bpm).
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Timepoint [12]
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60 Days post-randomization
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Secondary outcome [13]
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Adverse Events: Severe bradycardia
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Assessment method [13]
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Adverse events will be defined as; severe bradycardia (heart rate <50 bpm).
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Timepoint [13]
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60 Days post-randomization
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Secondary outcome [14]
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Adverse Events: Clinically significant bradycardia
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Assessment method [14]
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Adverse events will be defined as; clinically significant bradycardia (bradycardia requiring inotropes, vasopressors, external pacing, temporary pacemaker, or discontinuation of the trial medication).
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Timepoint [14]
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60 Days post-randomization
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Secondary outcome [15]
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Adverse Events: hypotension
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Assessment method [15]
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Adverse events will be defined as; hypotension (mean arterial pressure < 60mmHg, or >20mmHg below admission baseline).
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Timepoint [15]
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60 Days post-randomization
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Secondary outcome [16]
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Adverse Events: clinically significant hypotension
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Assessment method [16]
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Adverse events will be defined as; clinically significant hypotension (hypotension requiring vasopressors, fluid administration, or discontinuation of the trial medication).
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Timepoint [16]
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60 Days post-randomization
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Secondary outcome [17]
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Adverse Events: hypertension
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Assessment method [17]
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Adverse events will be defined as; hypertension (a systolic blood pressure >180mmHg or a diastolic blood pressure >110mmHg).
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Timepoint [17]
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60 Days post-randomization
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Secondary outcome [18]
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Adverse Events: Cardiac Arrest
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Assessment method [18]
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Adverse events will be defined as; cardiac arrest.
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Timepoint [18]
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60 Days post-randomization
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Secondary outcome [19]
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Functional Outcomes; quality of life
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Assessment method [19]
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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.
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Timepoint [19]
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60 Days post-randomization
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Secondary outcome [20]
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Functional Outcomes; clinical frailty
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Assessment method [20]
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Functional Outcomes will be defined as the "clinical frailty score" will be collected at pre-hospital, baseline, 28-Days and 60-Days post-randomization.
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Timepoint [20]
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60 Days post-randomization
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Eligibility
Key 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
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)
2. Patient expresses intolerance or requests removal of NIV secondary to
self-reported discomfort, anxiety, or claustrophobia
3. Other reason that the physician feels the patient is intolerant of NIV or
agitated, not captured above (all reasons will be recorded)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. 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
2. Persistent hypotension, defined as a mean arterial pressure (MAP) =60mmHg despite
volume resuscitation and vasopressors
3. Acute hepatic failure
4. Known allergy to dexmedetomidine
5. Pregnancy
6. Acute withdrawal from drugs or alcohol
7. Patients with post-extubation respiratory failure
8. Imminent need for endotracheal intubation
9. Death is deemed imminent and inevitable
10. Patient's goals of care do not include intubation and IMV
11. Patients already on dexmedetomidine at time of enrollment
12. Previously enrolled in the inDEX trial
13. Treating physician refuses enrollment (reasons for refusal will be captured)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/03/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/04/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
24
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Monash Medical Centre - Monash Health - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Ontario
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Country [2]
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Saudi Arabia
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State/province [2]
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Riyadh
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Funding & Sponsors
Primary sponsor type
Other
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Name
St. Joseph's Healthcare Hamilton
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Hamilton Academic Health Sciences Organization
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief 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. 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04878510
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Kimberley Lewis, MD
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Address
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Research Institute of St Joseph's Healthcare Hamilton
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04878510
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