Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001587493
Ethics application status
Approved
Date submitted
14/11/2016
Date registered
16/11/2016
Date last updated
17/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of obesity on the quality of CPR: a randomised cross over trial
Scientific title
The impact of obesity on the quality of CPR: a randomised cross over trial
Secondary ID [1] 290535 0
None
Universal Trial Number (UTN)
U1111-1189-8417
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 300959 0
Cardiac arrest 300960 0
Condition category
Condition code
Cardiovascular 300762 300762 0 0
Other cardiovascular diseases
Diet and Nutrition 300777 300777 0 0
Obesity

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

The intervention arm will be asked to perform two minutes of CPR on a manikin that has been encased in a suit containing pig fat in a vacuum sealed bag to a depth that mimics a BMI of 40 kg/m2.

The washout period between mannikins will be 5 minutes. We were concerned that 15 minutes between trials was excessive. In a trial of the methodology we found that participants HR had returned to baseline by 5 minutes and the washout period was reduced to this as a result..
Intervention code [1] 296393 0
Treatment: Other
Comparator / control treatment
The control arm will comprise the same participants performing CPR on a normal manikin.
Control group
Active

Outcomes
Primary outcome [1] 300181 0
Quality of CPR (composite endpoint comprising 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] 300181 0
2 minutes
Secondary outcome [1] 329261 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] 329261 0
2 minutes
Secondary outcome [2] 329262 0
Depth of CPR lies between 1/3 and 1/2 of the AP diameter of the thorax for > 90% of compressions assessed by data generated through electronic monitoring of chest wall movement (accelerometer) produced from specialised software.
Timepoint [2] 329262 0
2 minutes
Secondary outcome [3] 329263 0
Adequate thoracic cage recoil (full recoil of the thoracic cage for > 90% of compressions) assessed by data generated through electronic monitoring of chest wall movement (accelerometer) produced from specialised software.
Timepoint [3] 329263 0
2 minutes
Secondary outcome [4] 329264 0
Time taken to fatigue (inability to deliver high quality CPR i.e.: insufficient rate of compressions, insufficient depth of compressions or inadequate time for chest recoil) assessed by data generated through electronic monitoring of chest wall movement (accelerometer) produced from specialised software.
Timepoint [4] 329264 0
2 minutes
Secondary outcome [5] 329265 0
Association between perceived effectiveness and recorded effectiveness measured by comparing self assessed effectiveness of CPR using a visual analogue scale rated from 1 (not effective) to 10 (very effective) and the objective data generated through electronic monitoring of chest wall movement (accelerometer) produced from specialised software.
Timepoint [5] 329265 0
2 minutes
Secondary outcome [6] 329303 0
Staff discomfort / pain assessed by completion of a visual analogue scale from 1 (no discomfort / pain) to 10 (worse pain imaginable)
Timepoint [6] 329303 0
2 minutes

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 two 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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation generated by a coin toss
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Assuming that effective CPR will be conducted for 90% of compressions, to demonstrate a 15% deterioration in CPR efficacy, it is thought that a sample size of approximately 55 participants will be needed with an alpha of 0.05 and beta of 0.8. Calculated using Statistica(TM).

Results will be analysed using Statistica(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).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/05/2017
Actual
3/05/2017
Date of last participant enrolment
Anticipated
31/05/2017
Actual
16/05/2017
Date of last data collection
Anticipated
31/05/2017
Actual
16/05/2017
Sample size
Target
60
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
NT
Recruitment postcode(s) [1] 14606 0
0870 - Alice Springs

Funding & Sponsors
Funding source category [1] 294964 0
Hospital
Name [1] 294964 0
Alice Springs Hospital
Country [1] 294964 0
Australia
Primary sponsor type
Hospital
Name
Alice Springs Hospital
Address
Gap Road
Alice Springs NT 0870
Country
Australia
Secondary sponsor category [1] 293785 0
None
Name [1] 293785 0
None
Address [1] 293785 0
None
Country [1] 293785 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296324 0
CENTRAL AUSTRALIAN HUMAN RESEARCH ETHICS COMMITTEE (CAHREC)
Ethics committee address [1] 296324 0
CAHREC
PO BOX 4066
ALICE SPRINGS NT 0871
Ethics committee country [1] 296324 0
Australia
Date submitted for ethics approval [1] 296324 0
27/10/2016
Approval date [1] 296324 0
07/02/2017
Ethics approval number [1] 296324 0
HREC-16-445

Summary
Brief summary
There is little research regarding the efficacy of CPR in obese patients. The primary aim will be to assess whether hospital staff trained in BLS can deliver effective chest compressions in the setting of a CPR simulation using a dummy which is modified to reflect a patient with morbid obesity.

Aim of study:
* The aim of this study is to explore whether chest compressions in an obese patient are an effective part of the BLS and ALS algorithm and should continue to be used as part of resuscitative efforts during a cardiac arrest. In addition, this study aims to explore whether providers of CPR fatigue more rapidly when delivering CPR to morbidly obese patients.

Primary Outcome:
* The primary outcome is to measure the efficacy of chest compressions in a morbidly obese scenario. This will use 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 and at an adequate rate for more than 90% of compressions delivered.

Secondary outcomes:
* Adequacy of each component of CPR (namely depth, adequate recoil and rate).
* Time taken for staff 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 for is 2 minutes in a normal scenario.
* Staff discomfort/pain experienced performing CPR.
* The association between perceived effectiveness of chest compressions by staff and recorded adequacy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70446 0
Dr Paul Secombe
Address 70446 0
c/o Intensive Care Unit
Alice Springs Hospital
Gap Road
Alice Springs NT 0870
Country 70446 0
Australia
Phone 70446 0
+61 8 8951 7777
Fax 70446 0
+61 8 8951 6936
Email 70446 0
[email protected]
Contact person for public queries
Name 70447 0
Paul Secombe
Address 70447 0
c/o Intensive Care Unit
Alice Springs Hospital
Gap Road
Alice Springs NT 0870
Country 70447 0
Australia
Phone 70447 0
+61 8 8951 7777
Fax 70447 0
+61 8 8951 6936
Email 70447 0
[email protected]
Contact person for scientific queries
Name 70448 0
Paul Secombe
Address 70448 0
c/o Intensive Care Unit
Alice Springs Hospital
Gap Road
Alice Springs NT 0870
Country 70448 0
Australia
Phone 70448 0
+61 8 8951 7777
Fax 70448 0
Email 70448 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMorbid Obesity Impairs Adequacy of Thoracic Compressions in a Simulation-Based Model.2018https://dx.doi.org/10.1177/0310057X1804600205
N.B. These documents automatically identified may not have been verified by the study sponsor.