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Trial registered on ANZCTR


Registration number
ACTRN12616000773437
Ethics application status
Approved
Date submitted
26/02/2016
Date registered
14/06/2016
Date last updated
14/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The role of supplemental oxygen in improving rescuer performance of cardiac chest compressions: A randomised crossover trial
Scientific title
The role of supplemental oxygen in improving rescuer performance of cardiac chest compressions: A randomised crossover trial
Secondary ID [1] 288634 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
The SOCC Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiac arrest 297801 0
Condition category
Condition code
Cardiovascular 297980 297980 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will each perform three periods of 10 minutes of External Cardiac Compressions (ECC), swapping with their partner (research assistant) every 2 minutes as recommended by the Australian Resuscitation Council.

Each participant will perform on a resuscitation practice manikin:
1. ECC with room air (control: ECC-RA)
2. ECC with air via Nasal Cannula (NC) at 4 litres per minute (inspired oxygen fraction 21%)(intervention 1: ECC-A)
3. ECC with oxygen via NC at 4 litres per minute (estimated inspired oxygen fraction 36%)(intervention 2: ECC-O)

The NC will be administered administered continuously for the full 10 minutes of CPR. A washout period of 20 minutes will be performed between each arm.

Intervention code [1] 294044 0
Treatment: Drugs
Comparator / control treatment
The control treatment will be ECC with room air (ECC-RA)
Control group
Active

Outcomes
Primary outcome [1] 297501 0
'Time to inadequate CPR' whereby ECC performance is measured outside of the accepted adequate depth and rate of compression; depth (38-51mm) and rate (90-110 per minute). This will be measured using the CPR manikin software (Resusci Anne QCPR, Laerdel).

Timepoint [1] 297501 0
From start of CPR to time of inadequacy or 10 minutes.
Secondary outcome [1] 321237 0
Mean compression depth will be measured using the CPR manikin software (Resusci Anne QCPR, Laerdel).
Timepoint [1] 321237 0
Following each 10 mins period of ECC application.
Secondary outcome [2] 321238 0
No flow fraction will be measured using the CPR manikin software (Resusci Anne QCPR, Laerdel).
Timepoint [2] 321238 0
Following each 10 mins period of ECC application.
Secondary outcome [3] 324591 0
Self-reported participant comfort to wear NC during CPR will be assessed using a 10 point ordinal scale.
Timepoint [3] 324591 0
Following each 10 mins period of ECC application for arms ECC-A and ECC-O.
Secondary outcome [4] 324592 0
Self-reported participant convenience to wear NC during CPR will be assessed using a 10 point ordinal scale.
Timepoint [4] 324592 0
Following each 10 mins period of ECC application for arms ECC-A and ECC-O.
Secondary outcome [5] 324593 0
Self-reported participant fatigue during CPR will be assessed using a 10 point ordinal scale.
Timepoint [5] 324593 0
Following each 10 mins period of ECC application.

Eligibility
Key inclusion criteria
1. Adults
2. Hold qualifications as emergency medicine registrars/consultant, emergency registered nurse or a paramedic
3. Maintain a reasonable level of fitness
Minimum age
19 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Any contraindication to nasal cannula (e.g. nasal blockage).
2. Known chronic obstructive pulmonary disease

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 concealment will be preserved through the use of opaque allocation envelopes, whereby participants will select the next lowest number envelope which will contain allocation (mode 1, 2 or 3).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The order participants perform each mode of ECC will be randomised via a computer generated random sequence. Participants will commence with the mode prescribed by an allocation within the envelope then move to the next mode for the remaining two study modes. Each mode of ECC will be separated by a 20 minute washout (rest) period.
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
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mean time to fatigue (defined as the instant the rescuers quality of ECC dropped below the accepted benchmark) will be the primary outcome of interest and will be compared between study arms using an independent t test. Changes within individuals will be analysed using a paired t test.

Global ratings (comfort and convenience) will be treated as ordinal variables, and will be described using medians and inter-quartile ranges and compared between groups using Wilcoxon Rank Sum tests.

Statistical significance will be set at alpha=0.05.

We require 32 participants to ensure a power of 80% with an alpha level set at 5%. This calculation is based on a clinically important difference of 30 seconds and a standard deviation (of the difference in time to inadequate CPR for each participant) of 60 seconds.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2016
Actual
Date of last participant enrolment
Anticipated
15/08/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 292992 0
Self funded/Unfunded
Name [1] 292992 0
None
Country [1] 292992 0
Primary sponsor type
Hospital
Name
The Alfred
Address
Commercial Road
Melbourne Victoria 3004
Country
Australia
Secondary sponsor category [1] 291766 0
None
Name [1] 291766 0
None
Address [1] 291766 0
None
Country [1] 291766 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294500 0
Alfred Hospital Human Research Ethics Committee
Ethics committee address [1] 294500 0
Ethics committee country [1] 294500 0
Australia
Date submitted for ethics approval [1] 294500 0
31/08/2015
Approval date [1] 294500 0
28/09/2015
Ethics approval number [1] 294500 0
430/15

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

Contacts
Principal investigator
Name 63942 0
Prof Paul Jennings
Address 63942 0
Department of Community Emergency Health and Paramedic Practice
Faculty of Medicine, Nursing and Health Sciences
Monash University
PO BOX 527, Frankston, Victoria, 3199
Country 63942 0
Australia
Phone 63942 0
+61 3 9904 4264
Fax 63942 0
Email 63942 0
[email protected]
Contact person for public queries
Name 63943 0
Paul Jennings
Address 63943 0
Department of Community Emergency Health and Paramedic Practice
Faculty of Medicine, Nursing and Health Sciences
Monash University
PO BOX 527, Frankston, Victoria, 3199
Country 63943 0
Australia
Phone 63943 0
+61 3 9904 4264
Fax 63943 0
Email 63943 0
[email protected]
Contact person for scientific queries
Name 63944 0
Paul Jennings
Address 63944 0
Department of Community Emergency Health and Paramedic Practice
Faculty of Medicine, Nursing and Health Sciences
Monash University
PO BOX 527, Frankston, Victoria, 3199
Country 63944 0
Australia
Phone 63944 0
+61 3 9904 4264
Fax 63944 0
Email 63944 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
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