Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001616268
Ethics application status
Approved
Date submitted
18/09/2018
Date registered
2/10/2018
Date last updated
2/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intubation speed by experts in a simulated model of cardiac arrest with continuous cardiopulmonary resuscitation (CPR)
Scientific title
Intubation speed by experts in a simulated model of cardiac arrest with continuous cardiopulmonary resuscitation (CPR)
Secondary ID [1] 295897 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac arrest 309368 0
Condition category
Condition code
Emergency medicine 308512 308512 0 0
Resuscitation
Cardiovascular 308530 308530 0 0
Other cardiovascular diseases
Anaesthesiology 308531 308531 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A prospective, randomised, cross over trial.

Method:
1. Participants will be recruited by volunteering. It will be promoted through an internal email to Anaesthetics staff members of the Hunter New England Area Health Service and at Departmental meetings
2. The participants will be initially randomised to either a traditional ‘direct’ laryngoscope with size four mac-blade, or a McGrath® videolaryngoscope with size four blade using a random binary number generator (0,1). The binary outcome will be concealed in individual opaque envelopes.
3. Participants will enter the room with a high fidelity manikin undergoing continuous compressions via a Lucas II mechanical compression device.
4. The participant will be asked to hold the mask and self-inflating bag and when ready, attempt intubation with the randomly allocated device.
5. All participants will be required to intubate the manikin with a size 7 endotracheal tube (ETT), and bougie whilst the manikin is receiving continuous compressions.
6. A study author will record the time taken to successfully intubate and attempts made.
7. The participants will then be asked to do steps 3-5 using the alternate laryngoscope with a washout period of no less than 30seconds
8. The participants will be asked to complete a post-procedure questionnaire

Fidelity will be assessed by the post-task questionnaire, to be completed by candidates.
Intervention code [1] 312455 0
Treatment: Devices
Intervention code [2] 312456 0
Behaviour
Comparator / control treatment
Either direct or video laryngoscope, then crossover study to alternate laryngoscope.
Control group
Active

Outcomes
Primary outcome [1] 307485 0
Speed of intubation.

Participants were asked to intubate a manikin undergoing continuous CPR using:
1. Intubating whole body resuscitation manikin
2. Continuous CPR machine (Model LUCAS-2)
3. Stop-watch
4. Mask & self-inflating bag
5. Size 7 ETT
6. Direct laryngoscope with size 4 mac blade
7. Video laryngoscope (McGrath) with size 4 mac blade
8. Gum-elastic bougie
9. 10ml syringe for cuff inflation.

The time taken was assessed using a stopwatch to measure time from removal of BMV to successful delivery of first breath via ETT.
Timepoint [1] 307485 0
Time from removal of BMV to successful delivery of first breath via ETT during continuous CPR, measured immediately after attempt.
Secondary outcome [1] 352050 0
Attempts to pass bougie through cords using either direct or videolaryngoscope.

Bougie passes was calculated by the amount of times the bougie was pulled back/withdrawn.
I.e. if it took three attempts/motions to pass the bougie through the cords, attempts = 3.
Timepoint [1] 352050 0
During intubation attempts
Secondary outcome [2] 352153 0
Fidelity of task and manikin via post-task questionnaire:

Post-Task Questionnaire

1. How would you rate the fidelity of the manikin?

Very poor Poor Acceptable Good Very Good

2. How would you rate the fidelity of the task (intubating under continuous CPR)

Very poor Poor Acceptable Good Very Good

3. What was your comfort level during intubation with the direct laryngoscope?

Very low Low Acceptable High Very high

4. What was your comfort level during intubation with the video laryngoscope?

Very low Low Acceptable High Very high

5. To what extent has this study changed your opinion of which laryngoscope you would use in this situation?

Definitely not Probably not About the same Probably Definitely
Timepoint [2] 352153 0
Immediately after completion of task, using a post-task questionnaire.

Eligibility
Key inclusion criteria
Inclusion criteria:
1. Participants must be advanced trainees in anaesthesia (minimum two years of anaesthetic training) or higher (FANZCA)
2. Participants must have experience in both direct and video assisted laryngoscopy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria
1. Not an advanced trainee in anaesthesia or FANZCA.
2. Has participated in the study previously (one attempt per candidate only)

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)
concealed in individual opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence will be generated using an online binary sequence generator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Participants will use either direct or videolaryngoscopy to intubate the manikin, then will alternate and use the alternate laryngoscope to perform the same task.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size calculation was undertaken using pilot data from critical care paramedics. Assuming power 90%, alpha = 0.01, a mean difference (paired) = 4 seconds and a SD of the difference between groups of 5 seconds the sample size required was estimated to be n=24.

A more stringent power (90% vs 80%) and alpha (1% vs 5%) were selected to correct for unanticipated errors in any of the assumptions and to enable sub-group analysis (e.g. experience).

Null hypothesis:
H0: There is no difference between direct and videolaryngoscopy for intubation speed and success by expert users in a simulated patient undergoing continuous CPR.

Alternate hypothesis
H1: There is a difference between direct and videolaryngoscopy for intubation speed and success by expert users in a simulated patient undergoing continuous CPR.

Significance level:
a = 0.01

Statistical method: paired t-test (two tailed).

Statistical methodology:
1. The participants two data points will be paired.
2. A learning effect will be tested for, to see if the crossover (alternate laryngoscope attempt) is helped by the first via ‘difference of two means’ testing.
3. Time, attempts and successful intubation will be assessed and compared between the two groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/08/2018
Date of last participant enrolment
Anticipated
Actual
31/08/2018
Date of last data collection
Anticipated
Actual
31/08/2018
Sample size
Target
24
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11943 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 24088 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 300713 0
Hospital
Name [1] 300713 0
In-Kind support from Department of anaesthetics, John Hunter Hospital
Country [1] 300713 0
Australia
Primary sponsor type
Hospital
Name
Department of Anaesthesia and Pain Management, John Hunter Hospital
Address
John Hunter Hospital, Lookout Road, Lambton Heights, NSW, 2300
Country
Australia
Secondary sponsor category [1] 300248 0
None
Name [1] 300248 0
none
Address [1] 300248 0
none
Country [1] 300248 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301289 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 301289 0
Research Ethics and Governance Office
Hunter New England Local Health District
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 301289 0
Australia
Date submitted for ethics approval [1] 301289 0
31/05/2018
Approval date [1] 301289 0
30/06/2018
Ethics approval number [1] 301289 0
2018/ETH00230

Summary
Brief summary
Intubation speed by ‘experts’ in a simulated model of cardiac arrest with continuous chest compressions.

This study will examine the ability of intubating specialists to follow current guidelines and intubate during continuous CPR, which is rarely seen in clinical practice. This is a manikin based study, with practicing anaesthetists as participants for an ideal model.

Participants will use either a direct or videolaryngoscope to intubate, and will then use the alternate device in this crossover study.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
Attachments [1] 3103 3103 0 0
/AnzctrAttachments/375862-5.docx (Protocol)
Attachments [2] 3104 3104 0 0
/AnzctrAttachments/375862-Participant information REVISED Aug 2018.docx (Participant information/consent)

Contacts
Principal investigator
Name 86506 0
Dr Simon Ellis
Address 86506 0
Simon Ellis
C/O Department of Anaesthetics
John Hunter Hospital,
Lookout Road,
Lambton Heights, 2300
NSW, Australia
Country 86506 0
Australia
Phone 86506 0
+61 404100225
Fax 86506 0
Email 86506 0
[email protected]
Contact person for public queries
Name 86507 0
Dr Simon Ellis
Address 86507 0
Simon Ellis
C/O Department of Anaesthetics
John Hunter Hospital,
Lookout Road,
Lambton Heights, 2300
NSW, Australia
Country 86507 0
Australia
Phone 86507 0
+61 404100225
Fax 86507 0
Email 86507 0
[email protected]
Contact person for scientific queries
Name 86508 0
Dr Simon Ellis
Address 86508 0
Simon Ellis
C/O Department of Anaesthetics
John Hunter Hospital,
Lookout Road,
Lambton Heights, 2300
NSW, Australia
Country 86508 0
Australia
Phone 86508 0
+61 404100225
Fax 86508 0
Email 86508 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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