ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

U1111-1189-8417

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obesity

Cardiac arrest

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Diet and Nutrition

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]

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]

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]

2 minutes

Secondary outcome [1]

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]

2 minutes

Secondary outcome [2]

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]

2 minutes

Secondary outcome [3]

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]

2 minutes

Secondary outcome [4]

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]

2 minutes

Secondary outcome [5]

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]

2 minutes

Secondary outcome [6]

Staff discomfort / pain assessed by completion of a visual analogue scale from 1 (no discomfort / pain) to 10 (worse pain imaginable)

Timepoint [6]

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

Accrual to date

Final

100

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

0870 - Alice Springs

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Alice Springs Hospital

Address [1]

Gap Road
Alice Springs NT 0870

Country [1]

Australia

Primary sponsor type

Hospital

Name

Alice Springs Hospital

Address

Gap Road
Alice Springs NT 0870

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

CENTRAL AUSTRALIAN HUMAN RESEARCH ETHICS COMMITTEE (CAHREC)

Ethics committee address [1]

CAHREC
PO BOX 4066
ALICE SPRINGS NT 0871

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/10/2016

Approval date [1]

07/02/2017

Ethics approval number [1]

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

Dr Paul Secombe

Address

c/o Intensive Care Unit
Alice Springs Hospital
Gap Road
Alice Springs NT 0870

Country

Australia

Phone

+61 8 8951 7777

Fax

+61 8 8951 6936

paul.secombe@nt.gov.au

Contact person for public queries

Name

Paul Secombe

Address

c/o Intensive Care Unit
Alice Springs Hospital
Gap Road
Alice Springs NT 0870

Country

Australia

Phone

+61 8 8951 7777

Fax

+61 8 8951 6936

paul.secombe@nt.gov.au

Contact person for scientific queries

Name

Paul Secombe

Address

c/o Intensive Care Unit
Alice Springs Hospital
Gap Road
Alice Springs NT 0870

Country

Australia

Phone

+61 8 8951 7777

Fax

paul.secombe@nt.gov.au

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

Source	Title	Year of Publication	DOI
Embase	Morbid Obesity Impairs Adequacy of Thoracic Compressions in a Simulation-Based Model.	2018	https://dx.doi.org/10.1177/0310057X1804600205

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically