Out-Of-Hospital Cardiac Arrest Clinical Trial
— ORI-ONEOfficial title:
Can Non-invasive Multi-wavelength Monitoring of Out of Hospital Cardiac Arrest Having a Sustained ROSC Reduce Hyperoxia and Hypoxia During Hospital Transfer
Verified date | May 2022 |
Source | Centre Hospitalier Universitaire Saint Pierre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigator's research proposal is a randomized controlled study evaluating two different monitoring strategies to titrate FiO2 in order to rapidly and safely achieve optimal SatO2 targets during early ROSC of non-traumatic OHCA in adults. Primary hypothesis: Monitoring transport to hospital of sustained ROSC of OHCA patients using multiple wavelength detectors that allow ORI continuous measurement will reduce hyperoxia and hypoxia burden associated with transport. Secondary hypothesis: Multiple wavelength detectors allowing ORI continuous measurement will reduce hyperoxia at ER admission as measured via blood gas analysis. Tertiary study hypothesis: Multiple wavelength detectors allowing ORI continuous measurement will reduce reperfusion neuronal injury measured through NSE levels at 48h post ROSC
Status | Completed |
Enrollment | 100 |
Est. completion date | January 31, 2022 |
Est. primary completion date | January 10, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - out hospital cardiac arrest - non traumatic etiology - ROSC achieved Exclusion Criteria: - less 18 year - traumatic etiology - prisonnier - pregnant woman |
Country | Name | City | State |
---|---|---|---|
Belgium | Centre Hospitalier Universitaire Brugmann | Brussels | |
Belgium | CHU Saint Pierre | Bruxelles |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire Saint Pierre | Centre Hospitalier Universitaire Brugmann, Masimo Corporation |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | NSE concentrations | NSE concentrations as from laboratory measurements, biomarker of neuronal damage. Range are expected from 0,15µg/L up to 350 µg/L/ The highest is the result, the worst is the prognosis. | 48 hours after ROSC | |
Primary | normoxia index | Normoxia index = 1- ( Hypoxia index + Hyperoxia index). Varies from 0 to 1. 1 being a patient without hyper or hypoxia at any moment.
Hypoxia index=the area above the curve of SatO2 normalized on time. Varies from 0 to 1. 1 being a patient hypoxic during all experiment. Hyperoxia index=the area below the curve of ORI measurements and the arbitrary lower limit of an ORI index of 0 representing a PaO2 of approximatively 80mmHg. Varies from 0 to 1. 1 being a patient hyperoxic during all experiment. |
at date of randomisation, from Time of randomisation at ROSC up to time of hospital admission. | |
Secondary | Dissolved Oxygen in admission Blood gas sample (DO) | DO=Kh x PaO2. Range are expected to be from 0 to 6. 6 is associating with a higher hyperoxia. | at date of randomisation from time of hospital admission up to 30 minutes after time of hospital admission | |
Secondary | PaO2 in admission blood gas sample | PaO2 as from arterial blood sample. Range expected to be from 20mmHg to 600mmHg. Values between 60mmHg to 150mmHg being associated with the best prognosis | at date of randomisation from time of hospital admission up to 30 minutes after time of hospital admission |
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