rEduction of oXygen After Cardiac arresT: a Pilot Study
EXACT
1 other identifier
interventional
59
1 country
2
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2015
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 8, 2015
CompletedFirst Posted
Study publicly available on registry
July 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedSeptember 7, 2017
August 1, 2017
2.1 years
July 8, 2015
September 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
oxygen saturation ≥90%
Oxygen saturation measured on arrival at hospital by paramedics
baseline
Study Arms (2)
Oxygen reduction
EXPERIMENTALpost-ROSC oxygen reduced to 2L per minute then delivered to maintain oxygen saturation 90-94% to hospital
Standard Care
ACTIVE COMPARATORpost-ROSC oxygen maintained ≥10L per minute to hospital
Interventions
oxygen delivery by ETT/ SGA connected to bag/valve/oxygen reservoir
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Monash Universitylead
- Ambulance Victoriacollaborator
- SA Ambulance Servicecollaborator
- Curtin Universitycollaborator
- Flinders Universitycollaborator
Study Sites (2)
SA Ambulance Service
Adelaide, South Australia, Australia
Ambulance Victoria
Melbourne, Victoria, Australia
Related Publications (1)
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.
PMID: 29684433DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Bernard, MD
Monash University / Alfred Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 8, 2015
First Posted
July 15, 2015
Study Start
July 1, 2015
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
September 7, 2017
Record last verified: 2017-08