ORI to Reduce Hyperoxia After Out Hospital Cardiac Arrest

NCT03653325 | Completed DMC FDA Device

• 1 other identifier: ORI one
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

hyperoxia; post rosc; oxygen reserve index; Fi02 titration; post cardiac arrest care; oxygen

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Dissolved Oxygen in admission Blood gas sample (DO)

  at date of randomisation from time of hospital admission up to 30 minutes after time of hospital admission

• PaO2 in admission blood gas sample

  at date of randomisation from time of hospital admission up to 30 minutes after time of hospital admission

Other Outcomes (1)

• NSE concentrations

  48 hours after ROSC

Study Arms (2)

interventional arm

EXPERIMENTAL

In the interventional arm of the study clinicians will be encouraged to titrate oxygen FiO2 according to the following table: Interventional arm (FiO2 adaptation every 2-3 min) : ORI \>0.5 and SatO2\>98% and FiO2\>0.5 FiO2 reduction of 0.2 ORI\>0.01 and ORI\<0.5 and SatO2\>98% and FiO2\>0.5 FiO2 reduction of 0.1 ORI \>0.5 and SatO2\>98% and FiO2≤0.5 FiO2 reduction of 0.1 ORI\>0.01 and ORI\<0.5 and SatO2\>98% and FiO2≤0.5 FiO2 reduction of 0.05 ORI=0 et SatO2 94 - 98% no modification of FiO2 SatO2\<94% + SatO2\> 90% increase FiO2 by 0.05 SatO2\<90% and SatO2\>86 increase FiO2 by 0.1 SatO2\<86% and SatO2\> 80% increase FiO2 by 0.2 SatO2\<80% FiO2 at 1 In the absence of a ORI measurement reading FiO2 will be adapted as in the observational arm according to SatO2 only.

Device: ORI measurement; Device: oxygen saturation measurement

Observational arm

ACTIVE COMPARATOR

Observational arm (adaptation every 2-3 min): oxygen saturation measurement SatO2\>98% and FiO2\>0.5 reduction of FiO2 by 0.1 SatO2\>98% and FiO2≤0.5 reduction of FiO2 by 0.05 SatO2 94 - 98% no modification of FiO2 SatO2\<94% + SatO2\> 90% increase FiO2 by 0.05 SatO2\<90% and SatO2\>86 increase FiO2 by 0.1 SatO2\<86% and SatO2\> 80% increase FiO2 by 0.2 SatO2\<80% FiO2 at 1

Device: oxygen saturation measurement

Interventions

ORI measurement DEVICE

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

interventional arm

oxygen saturation measurement DEVICE

Oxygen (FiO2) will be titrated according to oxygen saturation

Observational arm; interventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• out hospital cardiac arrest
• non traumatic etiology
• ROSC achieved

You may not qualify if:

• less 18 year
• traumatic etiology
• prisonnier
• pregnant woman

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead
• Centre Hospitalier Universitaire Brugmann: collaborator
• Masimo Corporation: collaborator

Study Sites (2)

CHU Saint Pierre

Brussels, 1000, Belgium

Location

Centre Hospitalier Universitaire Brugmann

Brussels, 1090, Belgium

Location

Related Publications (1)

• Malinverni S, Wilmin S, Stoll T, de Longueville D, Preseau T, Mohler A, Bouazza FZ, Annoni F, Gerard L, Denoel P, Boutrika I. Postresuscitation oxygen reserve index-guided oxygen titration in out-of-hospital cardiac arrest survivors: A randomised controlled trial. Resuscitation. 2024 Jan;194:110005. doi: 10.1016/j.resuscitation.2023.110005. Epub 2023 Oct 18.

  PMID: 37863418 DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Hyperoxia

Interventions

Oximetry

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Officials

• stefano Malinverni

  Centre Hospitalier Universitaire Saint Pierre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective randomized controlled study

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: August 31, 2018
• Study Start: November 8, 2018
• Primary Completion: January 10, 2022
• Study Completion: January 31, 2022
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: After publication
• Access Criteria: Access will be granted to any researcher requesting access through Researchgate.com

Locations

BE (2)