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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
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
Secondary ID [1] 313299 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Care 335643 0
Tracheal Intubation 335705 0
Condition category
Condition code
Anaesthesiology 332198 332198 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 329876 0
Treatment: Drugs
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).
Control group
Active

Outcomes
Primary outcome [1] 339784 0
Area under Mean Arterial Blood Pressure (MAP) less than 65mmHg curve.
Timepoint [1] 339784 0
Measured every minute for 5 minutes pre-induction and the first 15 minutes following induction of anaesthesia.
Primary outcome [2] 339785 0
Feasibility - a multicentre trial will be considered feasible if 50 participants are enrolled over 8 months across 3 sites.
Timepoint [2] 339785 0
Enrollment rate at the conclusion of the enrollment period at 8 months.
Secondary outcome [1] 441296 0
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,
Timepoint [1] 441296 0
Measured every minute for 5 minutes pre-induction and the first 15 minutes following induction of anaesthesia.
Secondary outcome [2] 441297 0
Reduction in MAP < 80% of pre-induction blood pressure.
Timepoint [2] 441297 0
Measured every minute for 5 minutes pre-induction and the first 15 minutes following induction of anaesthesia.
Secondary outcome [3] 441298 0
Systolic Blood Pressure (SBP) < 90mmHg at any stage.
Timepoint [3] 441298 0
Measured every minute for 5 minutes pre-induction and the first 15 minutes following induction of anaesthesia.
Secondary outcome [4] 441299 0
Lowest SBP recorded.
Timepoint [4] 441299 0
Measured every minute for 5 minutes pre-induction and the first 15 minutes following induction of anaesthesia.
Secondary outcome [5] 441300 0
Profound hypotension, defined as SBP < 65mmHg
Timepoint [5] 441300 0
Measured every minute for 5 minutes pre-induction and the first 15 minutes following induction of anaesthesia.
Secondary outcome [6] 441301 0
Greatest drop in MAP relative to MAP less than 65mmHg.
Timepoint [6] 441301 0
Measured every minute for 5 minutes pre-induction and the first 15 minutes following induction of anaesthesia.
Secondary outcome [7] 441302 0
Slowest heart rate recorded.
Timepoint [7] 441302 0
Recorded every minute for 5 minutes pre-induction and the first 15 minutes following induction of anaesthesia.
Secondary outcome [8] 441303 0
Fastest heart rate recorded.
Timepoint [8] 441303 0
Recorded every minute for 5 minutes pre-induction and the first 15 minutes following induction of anaesthesia.
Secondary outcome [9] 441304 0
Need for push dose vasoactive medication to be administered.
Timepoint [9] 441304 0
Any time vasoactive medication is administered during first 15 minutes following induction of anaesthesia.
Secondary outcome [10] 441305 0
Total dose of push dose vasoactive medications.
Timepoint [10] 441305 0
Any time vasoactive medication is administered during the first 15 minutes following induction of anaesthesia.
Secondary outcome [11] 441306 0
Vasoactive medications infusion rate increased from baseline.
Timepoint [11] 441306 0
Any time vasoactive medication infusion rate is increased during first 15 minutes following induction of anaesthesia.
Secondary outcome [12] 441307 0
Commencement of new vasoactive medications infusion.
Timepoint [12] 441307 0
Any time new vasoactive medication infusion is commenced during first 15 minutes following induction of anaesthesia.
Secondary outcome [13] 441308 0
Difficult intubation.
Timepoint [13] 441308 0
Intubation grade (laryngoscopy views) recorded upon tracheal intubation.
Secondary outcome [14] 441309 0
Number of intubation attempts.
Timepoint [14] 441309 0
Upon intubation.
Secondary outcome [15] 441310 0
Composite outcome of failed intubation, change of operator, or oesophageal intubation.
Timepoint [15] 441310 0
At the time of intubation.
Secondary outcome [16] 441311 0
Lowest peripheral haemoglobin saturation of oxygen (SpO2).
Timepoint [16] 441311 0
Pulse oximetry measured every minute for 5 minutes prior to induction and for the first 15 minutes following induction of anaesthesia.
Secondary outcome [17] 441312 0
Profound hypoxia, defined as SpO2 less than 80%.
Timepoint [17] 441312 0
Every minute up till 15 minutes following induction of anaesthesia.
Secondary outcome [18] 441313 0
Delirium following extubation.
Timepoint [18] 441313 0
Delirium following extubation as recorded in the daily medical record until discharge from ICU.
Secondary outcome [19] 441314 0
ICU length of stay.
Timepoint [19] 441314 0
Censored at 28 days following tracheal intubation.
Secondary outcome [20] 441315 0
Hospital length of stay.
Timepoint [20] 441315 0
Censored at 28 days following tracheal intubation.
Secondary outcome [21] 441316 0
ICU mortality.
Timepoint [21] 441316 0
Censored at 28 days.
Secondary outcome [22] 441317 0
In-hospital mortality
Timepoint [22] 441317 0
Censored at 28 days.
Secondary outcome [23] 441318 0
Screening rate.
Timepoint [23] 441318 0
Screening rate from the screening log at the conclusion of enrollment period (8 months).
Secondary outcome [24] 441319 0
Proportion of screened to enrolled participants.
Timepoint [24] 441319 0
Screening rate from the screening log at the conclusion of enrollment period (8 months).
Secondary outcome [25] 441320 0
Protocol deviations.
Timepoint [25] 441320 0
During induction of anaesthesia.
Secondary outcome [26] 441321 0
Number of clinician-led exclusions of patients otherwise meeting eligibility criteria.
Timepoint [26] 441321 0
Number of clinician-led exclusions of patients otherwise meeting eligibility criteria recorded at the conclusion of enrollment period (8 months).
Secondary outcome [27] 441322 0
Ability to measure ICU and hospital mortality censored at 28 days.
Timepoint [27] 441322 0
Censored at 28 days following tracheal intubation.

Eligibility
Key inclusion criteria
Adults requiring emergency tracheal intubation in ICU.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/12/2024
Actual
Date of last participant enrolment
Anticipated
30/08/2025
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27292 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 27293 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 27294 0
Dandenong Hospital- Monash Health - Dandenong
Recruitment postcode(s) [1] 43381 0
3065 - Fitzroy
Recruitment postcode(s) [2] 43382 0
3050 - Parkville
Recruitment postcode(s) [3] 43383 0
3175 - Dandenong

Funding & Sponsors
Funding source category [1] 317750 0
Hospital
Name [1] 317750 0
St Vincent's Hosptial (Melbourne) ICU
Country [1] 317750 0
Australia
Funding source category [2] 317876 0
Hospital
Name [2] 317876 0
Royal Melbourne Hospital ICU
Country [2] 317876 0
Australia
Funding source category [3] 317877 0
Hospital
Name [3] 317877 0
Dandenong Hospital (Monash Health)
Country [3] 317877 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital (Melbourne) Ltd
Address
Country
Australia
Secondary sponsor category [1] 320067 0
None
Name [1] 320067 0
Address [1] 320067 0
Country [1] 320067 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316436 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 316436 0
Ethics committee country [1] 316436 0
Australia
Date submitted for ethics approval [1] 316436 0
03/03/2024
Approval date [1] 316436 0
28/10/2024
Ethics approval number [1] 316436 0
102502

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137894 0
Dr Alastair Brown
Address 137894 0
Department of Critical Care Medicine, St Vincent's Hospital (Melbourne), Fitzroy 3065 VIC
Country 137894 0
Australia
Phone 137894 0
+61422082137
Fax 137894 0
Email 137894 0
alastair.brown@svha.org.au
Contact person for public queries
Name 137895 0
Alastair Brown
Address 137895 0
Department of Critical Care Medicine, St Vincent's Hospital (Melbourne), Fitzroy 3065 VIC
Country 137895 0
Australia
Phone 137895 0
+61392314420
Fax 137895 0
Email 137895 0
alastair.brown@svha.org.au
Contact person for scientific queries
Name 137896 0
Alastair Brown
Address 137896 0
Department of Critical Care Medicine, St Vincent's Hospital (Melbourne), Fitzroy 3065 VIC
Country 137896 0
Australia
Phone 137896 0
+61392314420
Fax 137896 0
Email 137896 0
alastair.brown@svha.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided 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.