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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
rEduction of oXygen After Cardiac arresT (EXACT): a Pilot Study
Secondary ID [1] 0 0
CF14/2953-2014001634
Universal Trial Number (UTN)
Trial acronym
EXACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Arrest 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
oxygen saturation =90%
Timepoint [1] 0 0
baseline

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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2017
Sample size
Target
Accrual to date
Final
59
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
SA Ambulance Service - Adelaide
Recruitment hospital [2] 0 0
Ambulance Victoria - Melbourne
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Ambulance Victoria
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
SA Ambulance Service
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Curtin University
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Flinders University
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT02499042
Trial related presentations / publications
Bray JE, Hein C, Smith K, Stephenson M, Grantham H, Finn J, Stub D, Cameron P, Bernard S; EXACT Investigators. Oxygen titration after resuscitation from out-of-hospital cardiac arrest: A multi-centre, randomised controlled pilot study (the EXACT pilot trial). Resuscitation. 2018 Jul;128:211-215. doi: 10.1016/j.resuscitation.2018.04.019. Epub 2018 Apr 21.
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Bernard, MD
Address 0 0
Monash University / Alfred Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02499042