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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02499042
Registration number
NCT02499042
Ethics application status
Date submitted
8/07/2015
Date registered
15/07/2015
Date last updated
7/09/2017
Titles & IDs
Public title
rEduction of oXygen After Cardiac arresT: a Pilot Study
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Scientific title
rEduction of oXygen After Cardiac arresT (EXACT): a Pilot Study
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Secondary ID [1]
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CF14/2953-2014001634
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Universal Trial Number (UTN)
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Trial acronym
EXACT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Arrest
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Oxygen
Experimental: Oxygen reduction - post-ROSC oxygen reduced to 2L per minute then delivered to maintain oxygen saturation 90-94% to hospital
Active Comparator: Standard Care - post-ROSC oxygen maintained =10L per minute to hospital
Treatment: Drugs: Oxygen
oxygen delivery by ETT/ SGA connected to bag/valve/oxygen reservoir
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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oxygen saturation =90%
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Assessment method [1]
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Oxygen saturation measured on arrival at hospital by paramedics
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Timepoint [1]
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baseline
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Eligibility
Key inclusion criteria
- Adults (age =18 years)
- Out-of-hospital cardiac arrest of presumed cardiac cause
- Initial cardiac rhythm ventricular fibrillation/ ventricular tachycardia ("shockable")
- Unconscious (Glasgow Coma Scale <9)
- In cardiac arrest on ambulance arrival
- Sustained return of spontaneous circulation (>2 minutes)
- Pulse oximeter trace with oxygen saturation measured at =95% on bag/ reservoir with
oxygen set at =10L/min
- Patient is spontaneous breathing or ventilated using bag/valve/oxygen reservoir via
endotracheal tube or SGA (i.e. laryngeal mask airway)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Female who is known or suspected to be pregnant
- Dependant on others for activities of daily living (i.e. facilitated care or nursing
home residents)
- "Not for Resuscitation" order
- EMS witnessed arrests
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2017
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Sample size
Target
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Accrual to date
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Final
59
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
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SA Ambulance Service - Adelaide
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Recruitment hospital [2]
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Ambulance Victoria - Melbourne
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment postcode(s) [2]
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- Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Monash University
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Ambulance Victoria
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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SA Ambulance Service
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Curtin University
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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Flinders University
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Address [4]
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Country [4]
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Ethics approval
Ethics application status
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Summary
Brief summary
This Phase 2 study aims to determine the feasibility of paramedic titration of oxygen
delivery in adult patients who have been resuscitated from OHCA.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02499042
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Stephen Bernard, MD
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Address
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Monash University / Alfred Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02499042
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