Reoxygenation After Cardiac Arrest II (REOX II Study)
Completed · Phase 1
Conditions studied: Cardiac Arrest
In brief
The broad objective of this study is to test the association between hyperoxia exposure after resuscitation from cardiac arrest and outcome. After obtaining written informed consent subjects enrolled in REOX II will undergo a rapid faction of inspired oxygen (FiO2) optimization protocol to prevent exposure to hyperoxia. We will compare outcomes between subjects enrolled in REOX I (observational study only) and REOX II (intervention: rapid FiO2 optimization protocol). Our overarching hypothesis is that exposure to hyperoxia after return of spontaneous circulation (ROSC) is associated with increased oxidative stress and worsened neurological and cognitive outcomes.
Key facts
- Study ID
- NCT02698826
- Run by
- The Cooper Health System
- People needed
- 16
- Starts
- 2016-04-01
- Expected to finish
- 2018-10-01
- Last updated by the study team
- 2022-03-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age >17 years
- Cardiac arrest
- Return of spontaneous circulation
- Not following commands immediately after ROSC
- Endotracheal intubation
- Clinician intent to treat with therapeutic hypothermia (or absence of clinician intent to withhold therapeutic hypothermia)
You may not qualify if…
- Presumed etiology of arrest is trauma
- Presumed etiology of arrest is hemorrhage
- Presumed etiology of arrest is sepsis
- Permanent resident of nursing home or other long-term care facility
- Any other condition, that in the opinion of the investigator, would preclude the subject from being a suitable candidate, e.g. end stage chronic illness with no reasonable expectation of survival to hospital discharge
Where it is running
- Indiana University/ Methodist Hospital — Indianapolis, Indiana, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- University of Mississippi Medical Center — Jackson, Mississippi, United States
- Cooper University Hospital — Camden, New Jersey, United States
- Hospital of the University of Pennsylvania and Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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