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ORI to Reduce Hyperoxia After Out Hospital Cardiac Arrest

NCT03653325 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-05-19

No results posted yet for this study

Summary

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

Conditions

  • Out-Of-Hospital Cardiac Arrest
  • Oxygen Toxicity

Interventions

DEVICE

ORI measurement

Oxygen (FiO2) will be titrated according to ORI index and Oxygen saturation.

DEVICE

oxygen saturation measurement

Oxygen (FiO2) will be titrated according to oxygen saturation

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Brugmann

    collaborator OTHER

  • Masimo Corporation

    collaborator INDUSTRY

  • Centre Hospitalier Universitaire Saint Pierre

    lead OTHER

Principal Investigators

  • stefano Malinverni · Centre Hospitalier Universitaire Saint Pierre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-08
Primary Completion
2022-01-10
Completion
2022-01-31
FDA Device
Yes

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03653325 on ClinicalTrials.gov