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Trial registered on ANZCTR
Registration number
ACTRN12624001418561
Ethics application status
Approved
Date submitted
4/11/2024
Date registered
3/12/2024
Date last updated
3/12/2024
Date data sharing statement initially provided
3/12/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Ketamine when compared to usual care as induction drugs for tracheal intubation of critically ill patients: A prospective, blinded, parallel-group, randomised, feasibility trial
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Scientific title
Ketamine when compared to usual care as induction drugs for tracheal intubation of critically ill patients: A prospective, blinded, parallel-group, randomised, feasibility trial
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Secondary ID [1]
313299
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Tracheal Intubation
335705
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Critical Care
335643
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Condition category
Condition code
Anaesthesiology
332198
332198
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0
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Anaesthetics
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
For patients undergoing emergency tracheal intubation in ICU, induction of anaesthesia will be using intravenous ketamine hydrochloride 1-2mg/kg (ideal body weight).
A dedicated scribe will record administration of intubation drugs including the study drug into the Case Report Form during the procedure to ensure adherence to intervention. This will be verified against the dose recorded in the patient's hospital record.
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Intervention code [1]
329876
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Treatment: Drugs
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Comparator / control treatment
For patients undergoing emergency tracheal intubation in ICU, usual care drugs for induction of anaesthesia will be at treating clinician's discretion, which may include the combination of propofol, fentanyl, and/or midazolam as adjunct (without using ketamine).
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Control group
Active
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Outcomes
Primary outcome [1]
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Area under Mean Arterial Blood Pressure (MAP) less than 65mmHg curve.
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Assessment method [1]
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Serial non-invasive blood pressure measurements at 1 minute intervals using automated non-invasive oscillometric blood pressure monitor.
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Timepoint [1]
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Measured every minute for 5 minutes pre-induction and the first 15 minutes following induction of anaesthesia.
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Primary outcome [2]
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Feasibility - a multicentre trial will be considered feasible if 50 participants are enrolled over 8 months across 3 sites.
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Assessment method [2]
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Enrollment rate, defined as number of participants enrolled over the duration of the trial. Data will be obtained from the enrollment log of the study.
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Timepoint [2]
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Enrollment rate at the conclusion of the enrollment period at 8 months.
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Secondary outcome [1]
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Total dose of push dose vasoactive medications.
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Assessment method [1]
441305
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Dedicated scribe will record the name and dose of vasoactive medication given at the time of intubation into the Case Report Form. Total dose of push dose vasoactive medications will also be tallied and recorded into the Case Report Form. This will be verified against the dose recorded in the patient's hospital record.
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Timepoint [1]
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Any time vasoactive medication is administered during the first 15 minutes following induction of anaesthesia.
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Secondary outcome [2]
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Lowest SBP recorded.
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Assessment method [2]
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Serial non-invasive blood pressure measurements at 1 minute intervals using automated non-invasive oscillometric blood pressure monitor.
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Timepoint [2]
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Measured every minute for 5 minutes pre-induction and the first 15 minutes following induction of anaesthesia.
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Secondary outcome [3]
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Fastest heart rate recorded.
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Assessment method [3]
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Continuous Electrocardiogram monitoring.
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Timepoint [3]
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Recorded every minute for 5 minutes pre-induction and the first 15 minutes following induction of anaesthesia.
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Secondary outcome [4]
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ICU length of stay.
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Assessment method [4]
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Total ICU length of stay taken from the medical record.
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Timepoint [4]
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Censored at 28 days following tracheal intubation.
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Secondary outcome [5]
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Screening rate.
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Assessment method [5]
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Number of patients screened vs total number of patients meeting eligibility criteria.
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Timepoint [5]
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Screening rate from the screening log at the conclusion of enrollment period (8 months).
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Secondary outcome [6]
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Profound hypotension, defined as SBP < 65mmHg
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Assessment method [6]
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Serial non-invasive blood pressure measurements at 1 minute intervals using automated non-invasive oscillometric blood pressure monitor.
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Timepoint [6]
441300
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Measured every minute for 5 minutes pre-induction and the first 15 minutes following induction of anaesthesia.
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Secondary outcome [7]
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Profound hypoxia, defined as SpO2 less than 80%.
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Assessment method [7]
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Continuous pulse oximetry.
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Timepoint [7]
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Every minute up till 15 minutes following induction of anaesthesia.
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Secondary outcome [8]
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Need for push dose vasoactive medication to be administered.
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Assessment method [8]
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The dedicated scribe will record the name and dose of vasoactive medication given at the time of intubation into the Case Report Form. This will be verified against the dose recorded in the patient's hospital record.
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Timepoint [8]
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Any time vasoactive medication is administered during first 15 minutes following induction of anaesthesia.
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Secondary outcome [9]
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Proportion of screened to enrolled participants.
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Assessment method [9]
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Ratio of screened vs enrolled participants.
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Timepoint [9]
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Screening rate from the screening log at the conclusion of enrollment period (8 months).
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Secondary outcome [10]
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Reduction in MAP < 80% of pre-induction blood pressure.
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Assessment method [10]
441297
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Serial non-invasive blood pressure measurements at 1 minute intervals using automated non-invasive oscillometric blood pressure monitor.
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Timepoint [10]
441297
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Measured every minute for 5 minutes pre-induction and the first 15 minutes following induction of anaesthesia.
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Secondary outcome [11]
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Composite binary outcome: post-induction hypotension, increase in vasoactive medication infusion rate or administration of push dose vasoactive medications, commencement of vasoactive medications, profound hypotension (Mean Arterial Blood Pressure < 65mmHg), or need for cardiopulmonary resuscitation,
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Assessment method [11]
441296
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Serial non-invasive blood pressure measurements at 1 minute intervals using automated non-invasive oscillometric blood pressure monitor.
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Timepoint [11]
441296
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Measured every minute for 5 minutes pre-induction and the first 15 minutes following induction of anaesthesia.
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Secondary outcome [12]
441298
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Systolic Blood Pressure (SBP) < 90mmHg at any stage.
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Assessment method [12]
441298
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Serial non-invasive blood pressure measurements at 1 minute intervals using automated non-invasive oscillometric blood pressure monitor.
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Timepoint [12]
441298
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Measured every minute for 5 minutes pre-induction and the first 15 minutes following induction of anaesthesia.
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Secondary outcome [13]
441302
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Slowest heart rate recorded.
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Assessment method [13]
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Continuous Electrocardiogram monitoring.
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Timepoint [13]
441302
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Recorded every minute for 5 minutes pre-induction and the first 15 minutes following induction of anaesthesia.
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Secondary outcome [14]
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Lowest peripheral haemoglobin saturation of oxygen (SpO2).
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Assessment method [14]
441311
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Continuous pulse oximetry.
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Timepoint [14]
441311
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Pulse oximetry measured every minute for 5 minutes prior to induction and for the first 15 minutes following induction of anaesthesia.
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Secondary outcome [15]
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Delirium following extubation.
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Assessment method [15]
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Confusion Assessment Method for the ICU (CAM-ICU) performed daily.
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Timepoint [15]
441313
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Delirium following extubation as recorded in the daily medical record until discharge from ICU.
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Secondary outcome [16]
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Difficult intubation.
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Assessment method [16]
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Cormack-Lehane grade of intubation III or IV, or Percentage of Glottic Opening (POGO) < 50% on video laryngoscopy.
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Timepoint [16]
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Intubation grade (laryngoscopy views) recorded upon tracheal intubation.
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Secondary outcome [17]
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Ability to measure ICU and hospital mortality censored at 28 days.
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Assessment method [17]
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All ICU and hospital mortality followed up via hospital record and compared to Australia and New Zealand Intensive Care Society Adult Patient Database (ANZICS APD).
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Timepoint [17]
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Censored at 28 days following tracheal intubation.
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Secondary outcome [18]
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Number of intubation attempts.
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Assessment method [18]
441309
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A dedicated scribe will record operator reported number of attempts at tracheal intubation into the Case Report Form.
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Timepoint [18]
441309
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Upon intubation.
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Secondary outcome [19]
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Number of clinician-led exclusions of patients otherwise meeting eligibility criteria.
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Assessment method [19]
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All patients requiring emergency intubation in ICU who meet eligibility criteria but excluded by clinician reviewed and the reasons for exclusion recorded in the screening log.
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Timepoint [19]
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Number of clinician-led exclusions of patients otherwise meeting eligibility criteria recorded at the conclusion of enrollment period (8 months).
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Secondary outcome [20]
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Vasoactive medications infusion rate increased from baseline.
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Assessment method [20]
441306
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A dedicated scribe will record into the Case Report Form any increase in vasoactive medication infusion rate following induction of anaesthesia when compared to baseline rate prior to induction. This will be verified against the dose recorded in the patient's hospital record.
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Timepoint [20]
441306
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Any time vasoactive medication infusion rate is increased during first 15 minutes following induction of anaesthesia.
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Secondary outcome [21]
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ICU mortality.
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Assessment method [21]
441316
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Death in ICU within first 28 days following tracheal intubation,
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Timepoint [21]
441316
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Censored at 28 days.
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Secondary outcome [22]
441310
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Composite outcome of failed intubation, change of operator, or oesophageal intubation.
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Assessment method [22]
441310
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A dedicated scribe will record any failed intubation, change in operator/proceduralist, or oesophageal intubation into the Case Report Form.
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Timepoint [22]
441310
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At the time of intubation.
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Secondary outcome [23]
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Greatest drop in MAP relative to MAP less than 65mmHg.
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Assessment method [23]
441301
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Serial non-invasive blood pressure measurements at 1 minute intervals using automated non-invasive oscillometric blood pressure monitor.
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Timepoint [23]
441301
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Measured every minute for 5 minutes pre-induction and the first 15 minutes following induction of anaesthesia.
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Secondary outcome [24]
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Protocol deviations.
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Assessment method [24]
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Adherence to protocol and group allocations as recorded by the dedicated scribe compared to what is entered into the medical record reviewed by research team and reported to project safety officer.
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Timepoint [24]
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During induction of anaesthesia.
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Secondary outcome [25]
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Commencement of new vasoactive medications infusion.
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Assessment method [25]
441307
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A dedicated scribe will record the name and dose of vasoactive medication commenced around the time of intubation into the Case Report Form.
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Timepoint [25]
441307
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Any time new vasoactive medication infusion is commenced during first 15 minutes following induction of anaesthesia.
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Secondary outcome [26]
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Hospital length of stay.
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Assessment method [26]
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Total hospital length of stay taken from the medical record.
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Timepoint [26]
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Censored at 28 days following tracheal intubation.
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Secondary outcome [27]
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In-hospital mortality
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Assessment method [27]
441317
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Death in hospital within first 28 days following tracheal intubation.
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Timepoint [27]
441317
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Censored at 28 days.
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Eligibility
Key inclusion criteria
Adults requiring emergency tracheal intubation in ICU.
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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. Age < 18 years old
2. Death during ICU admission deemed inevitable.
3. Patient with Not for Resuscitation/Do not Resuscitate order.
4. Patient is pregnant or suspected to be pregnant.
5. Known allergy or contraindiation to administration of ketamine or propofol.
6. Cardiac arrest where the standard practice is not to use induction medications.
7. Patient with severe hypertension Systolic Blood Pressure > 180mmHg.
8. Patient with known aortic aneurysm or dissection.
9. Patient with known unsecured cerebral aneurysm.
10. Patient previously been enrolled in this study.
11. Clinician deems patient not suitable or participation deemed not in patient's best interests.
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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)
Sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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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 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
Efficacy
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Statistical methods / analysis
We will use a convenience sample of all eligible patients over the study period and as such the sample size will be determined by study enrolment rate. Categorical data will be summarised as counts and proportions and compared using the chi-square test or fisher’s exact test depending on eventual study sample size. Continuous variables will be summarised as median with an interquartile range and compared using the Wilcoxon rank-sum test.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
30/12/2024
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Actual
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Date of last participant enrolment
Anticipated
30/08/2025
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Actual
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Date of last data collection
Anticipated
30/09/2025
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Royal Melbourne Hospital - City campus - Parkville
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Recruitment hospital [2]
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Dandenong Hospital- Monash Health - Dandenong
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Recruitment hospital [3]
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St Vincent's Hospital (Melbourne) Ltd - Fitzroy
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Recruitment postcode(s) [1]
43382
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3050 - Parkville
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Recruitment postcode(s) [2]
43383
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3175 - Dandenong
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Recruitment postcode(s) [3]
43381
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3065 - Fitzroy
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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St Vincent's Hosptial (Melbourne) ICU
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Address [1]
317750
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Country [1]
317750
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Australia
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Funding source category [2]
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Hospital
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Name [2]
317877
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Dandenong Hospital (Monash Health)
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Address [2]
317877
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Country [2]
317877
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Australia
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Funding source category [3]
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Hospital
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Name [3]
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Royal Melbourne Hospital ICU
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Address [3]
317876
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Country [3]
317876
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Australia
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Primary sponsor type
Hospital
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Name
St Vincent's Hospital (Melbourne) Ltd
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
320067
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Address [1]
320067
0
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Country [1]
320067
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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St Vincent's Hospital Melbourne Human Research Ethics Committee
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Ethics committee address [1]
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https://svhm.org.au/home/research/researchers/human-research-ethics-committee
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
316436
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03/03/2024
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Approval date [1]
316436
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28/10/2024
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Ethics approval number [1]
316436
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102502
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Summary
Brief summary
Tracheal intubation represents considerable risk in critically ill patients. Hypotension following induction has been found to be associated with increased mortality and hospital length of stay. One of the contributors to hypotension may be the type of induction medication used. Ketamine is widely adopted in the emergency department and pre-hospital setting due to its haemodynamic stability. This feasibility trial will aim to allocate 50 patients (25 in each arm) to receive either ketamine-only induction or usual care. The primary outcome is the area under Mean arterial blood pressure (MAP) less than 65mmHg curve. The results will inform design of larger multi-centre trials and the outcomes that will be studied in the future trials.
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Trial website
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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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Dr Alastair Brown
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Address
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Department of Critical Care Medicine, St Vincent's Hospital (Melbourne), Fitzroy 3065 VIC
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Country
137894
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Australia
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Phone
137894
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+61422082137
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Fax
137894
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Email
137894
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[email protected]
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Contact person for public queries
Name
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Alastair Brown
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Address
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Department of Critical Care Medicine, St Vincent's Hospital (Melbourne), Fitzroy 3065 VIC
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Country
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Australia
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Phone
137895
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+61392314420
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Fax
137895
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Email
137895
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[email protected]
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Contact person for scientific queries
Name
137896
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Alastair Brown
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Address
137896
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Department of Critical Care Medicine, St Vincent's Hospital (Melbourne), Fitzroy 3065 VIC
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Country
137896
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Australia
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Phone
137896
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+61392314420
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Fax
137896
0
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Email
137896
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment:
Sharing of participant data is not part of our current ethics approval. Additionally, the study is a pilot trial and the results will inform the design of future trials and are hypothesis generating only.
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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