Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000011189
Ethics application status
Approved
Date submitted
19/12/2018
Date registered
8/01/2019
Date last updated
14/02/2020
Date data sharing statement initially provided
8/01/2019
Date results information initially provided
14/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the use of Bariboard(TM) improve adequacy of chest compressions in morbid obesity?
Scientific title
Does the use of Bariboard(TM) improve adequacy of chest compressions in morbid obesity?
Secondary ID [1] 296890 0
None
Universal Trial Number (UTN)
U1111-1225-6682
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 310829 0
Cardiac Arrest 310830 0
Condition category
Condition code
Diet and Nutrition 309504 309504 0 0
Obesity
Cardiovascular 309505 309505 0 0
Other cardiovascular diseases
Emergency medicine 309561 309561 0 0
Resuscitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised, blinded cross over design

The intervention arm will be asked to perform two minutes of uninterrupted CPR on a mannequin that has been encased in a suit containing pig fat in a vacuum sealed bag to a depth that mimics a BMI of 40kg/m2, with the Bariboard(TM) device in use. The Bariboard(TM) is a piece of equipment that is placed under the supine bariatric patient during CPR, which has been designed to better support the the spine and torso as it is contoured with the larger patient in mind. The additional support to the spine and thorax aims to decrease patient's posterior surface area and change force distribution during CPR, increasing the effectiveness of chest compressions delivered by the rescuer. CPR will be uninterrupted compressions, at participants discretion (i.e. without prompting from examiners), although revision of the elements of adequate compressions as per standard Australian BLS guidelines (ANZCOR) with the participants will occur just prior to completing the station.

Blinding will occur by concealing the device within the sheeting of the bed on which the mannequin lies.

There will be a washout period between each arm of 5 minutes to allow participant recovery.
Intervention code [1] 313185 0
Treatment: Devices
Comparator / control treatment
The control arm will comprise of the same participants performing CPR on a mannequin that has been encased in a suit containing pig fat in a vacuum sealed bag to a depth that mimics a BMI of 40kg/m2.
Control group
Active

Outcomes
Primary outcome [1] 308482 0
Quality of CPR (composite endpoint comprising of rate of compressions, depth of compressions, and adequate chest recoil for >90% of compressions) assessed by data generated through electronic monitoring of chest wall movement (accelerometer) produced from specialised software.
Timepoint [1] 308482 0
For the duration of 2 minutes of uninterrupted CPR
Secondary outcome [1] 355117 0
Rate of CPR lies between 100 and 120 bpm for >90% of compressions, assessed by data generated through electronic monitoring of chest wall movement (accelerometer) produced from specialised software.
Timepoint [1] 355117 0
For the duration of 2 minutes of uninterrupted CPR
Secondary outcome [2] 355118 0
Depth of CPR lies between 1/3 and 1/2 of the antero-posterior diameter of the thorax for >90% of compressions, using data generated through electronic monitoring of chest wall movement (accelerometer connected to a ZOLL defibrillator).
Timepoint [2] 355118 0
For the duration of 2 minutes of uninterrupted CPR
Secondary outcome [3] 355119 0
Adequate thoracic cage recoil (full recoil for >90% of compressions), using data generated through electronic monitoring of chest wall movement (accelerometer connected to a ZOLL defibrillator)
Timepoint [3] 355119 0
For the duration of 2 minutes of uninterrupted CPR
Secondary outcome [4] 355120 0
Time taken to fatigue (inability to delivier high quality CPR i.e. insufficient rate of compressions, insufficient depth of compressions or inadequate time for chest wall recoil); determined using data generated for each of these values for each candidate by a ZOLL defibrillator attached to the mannequin.
Timepoint [4] 355120 0
For the duration of 2 minutes of uninterrupted CPR
Secondary outcome [5] 355121 0
Perceived effectiveness of cardiac compressions as measured by a questionnaire using a visual analogue scale (VAS). The VAS questionnaire was designed for this study and is not validated.
Timepoint [5] 355121 0
At the completion of 2 minutes of uninterrupted CPR
Secondary outcome [6] 365377 0
Participant discomfort/pain experienced whilst performing CPR assessed by completion of a visual analogue scale from 1 (no discomfort/pain) to 10 (worst pain imaginable).
Timepoint [6] 365377 0
At the completion of 2 minutes of uninterrupted CPR

Eligibility
Key inclusion criteria
Health care staff who have previously undergone BLS training and would be expected to provide CPR during cardiopulmonary arrest.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Untrained in BLS
Unable to undertake 2 minutes of CPR
Currently undergoing a managed return to work program

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)
Allocation is not concealed. Participants will be recruited based on convenience (released from clinical duties), and randomised by coin toss following informed consent.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will only occur following recruitment of particpants with a coin toss determining the order which they complete the CPR workstations.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Randomised controlled crossover trial

On the basis of our previous research, in which 4% of rescuers could provide adequate chest compressions, in order to demonstrate a clinically significant improvement (10% of rescuers acheiving "adequate compressions", or a 150% improvement) with an alpha of 0.05 and a beta of 0.8, 113 participants would be required.

Results will be analysed using STATA(TM). Non-parametric data will be analysed using the Chi squared statistic (efficacy of CPR, rate, adequate depth, adequate recoil for >90% of compressions, difference between perceived and actual effectiveness).

Parametric data will be analysed using the students t-test (time taken to fatigue, level of discomfort/pain).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2019
Actual
13/02/2019
Date of last participant enrolment
Anticipated
28/02/2019
Actual
21/08/2019
Date of last data collection
Anticipated
28/02/2019
Actual
21/08/2019
Sample size
Target
120
Accrual to date
Final
205
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 12773 0
Alice Springs Hospital - Alice Springs
Recruitment postcode(s) [1] 25234 0
0870 - Alice Springs

Funding & Sponsors
Funding source category [1] 301462 0
Hospital
Name [1] 301462 0
Alice Springs Hospital
Country [1] 301462 0
Australia
Funding source category [2] 301505 0
Commercial sector/Industry
Name [2] 301505 0
Iron Duck
Country [2] 301505 0
United States of America
Funding source category [3] 301506 0
Commercial sector/Industry
Name [3] 301506 0
ZOLL Medical Australia Pty Ltd
Country [3] 301506 0
Australia
Primary sponsor type
Hospital
Name
Alice Springs Hospital
Address
Gap Road
Alice Springs NT 0870
Country
Australia
Secondary sponsor category [1] 301203 0
None
Name [1] 301203 0
Address [1] 301203 0
Country [1] 301203 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302196 0
CENTRAL AUSTRALIAN HUMAN RESEARCH ETHICS COMMITEE (CAHREC)
Ethics committee address [1] 302196 0
CAHREC
PO BOX 4066
Alice Springs, NT 0870
Ethics committee country [1] 302196 0
Australia
Date submitted for ethics approval [1] 302196 0
09/11/2018
Approval date [1] 302196 0
12/12/2018
Ethics approval number [1] 302196 0
CA-18-3273

Summary
Brief summary
There is little research regarding the efficacy of CPR in obese patients. Using a simulation model we have previously demonstrated that the adequacy of chest compressions in morbidly obese mannequins is compromised, predominantly in the domains of achieving adequate compression depth and allowing sufficient time for chest wall recoil during CPR.

The Bariboard(TM) is a device that purports to aid in the redistribution of forces applied to the anterior chest wall in order to improve the adequacy of chest compression. There have been no empirical trials using this device.

Aim of Study:
The primary aim of this study will be to explore whether the adequacy of chest compressions can be improved using a mechanical device (Bariboard(TM)) to better distribute the mechanical forces applied to the anterior thorax during CPR.

Primary outcome:
* To measure the efficacy of chest compressions using a previously described model of morbid obesity with and without a mechanical device that raises the thoracic cage. This will use the digital mannequins to record the quality and adequacy of chest compressions over a period of 2 minutes of uninterrupted CPR. Effective CPR will be defined as a composite measure of adequate depth of compression, adequate time for recoil at an adequate rate for >90% of compressions delivered.

Secondary outcomes:
* Adequacy of each component of CPR (namely rate, depth of compressions and adequate recoil).
* Time taken for participants to fatigue when performing CPR on a morbidly obese mannequin. It is known that the maximum amount of time a member of staff can perform effective CPR is 2 minutes in a normal scenario.
* Participant discomfort/pain experienced during CPR.
* The association between staffs' perceived effectiveness and the recorded adequacy of chest compressions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89442 0
Dr Kate Goulding
Address 89442 0
c/o Intensive Care Unit
Alice Springs Hospital
6 Gap Road
Alice Springs NT 0870
Country 89442 0
Australia
Phone 89442 0
+61 428306130
Fax 89442 0
Email 89442 0
[email protected]
Contact person for public queries
Name 89443 0
Dr Paul Secombe
Address 89443 0
c/o Intensive Care Unit
Alice Springs Hospital
6 Gap Road
Alice Springs NT 0870
Country 89443 0
Australia
Phone 89443 0
+61 8 8951 7777
Fax 89443 0
+61 8 8951 6936
Email 89443 0
[email protected]
Contact person for scientific queries
Name 89444 0
Dr Paul Secombe
Address 89444 0
c/o Intensive Care Unit
Alice Springs Hospital
6 Gap Road
Alice Springs NT 0870
Country 89444 0
Australia
Phone 89444 0
+61 8 8951 7777
Fax 89444 0
+61 8 8951 6936
Email 89444 0
[email protected]

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


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.