Out-Of-Hospital Cardiac ArrestORI-ONENCT03653325
ORI to Reduce Hyperoxia After Out Hospital Cardiac Arrest
A study testing ORI measurement and oxygen saturation measurement in people with Out-Of-Hospital Cardiac Arrest and Oxygen Toxicity, run by Centre Hospitalier Universitaire Saint Pierre at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest, Oxygen Toxicity
- What is being tested?
- ORI measurement and oxygen saturation measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesBelgium
- Study dates
- 8 Nov 2018to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- out hospital cardiac arrest
- non traumatic etiology
- ROSC achieved
Who cannot join
- less 18 year
- traumatic etiology
- prisonnier
- pregnant woman
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
CHU Saint Pierre
Brussels, 1000
Centre Hospitalier Universitaire Brugmann
Brussels, 1090
About this study
Official title: Can Non-invasive Multi-wavelength Monitoring of Out of Hospital Cardiac Arrest Having a Sustained ROSC Reduce Hyperoxia and Hypoxia During Hospital Transfer
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:
Read more
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
Read the detailed description
Oxygen has a pivotal role in emergency medicine as a lifesaving therapy in numerous situations. In order to avoid hypoxia-related morbidity and mortality, oxygen is delivered in emergencies in a liberal way, even when hypoxia is not confirmed. Nevertheless, as every medication, experimental and clinical studies have highlighted potential side effects of high oxygen tension that could worsen outcome. Cardiac arrest is the archetypal situation given the urgent need of rapid oxygen delivery to organs. However, this global ischemia-reperfusion syndrome produces high amounts ROS that could magnify the damages of the ischemic period and might be significantly increased by high oxygen tension. Thus, hyperoxia in the post-resuscitation context of cardiac arrest is an important topic. Advances in noninvasive oxygen monitoring can now allow for non-invasive monitoring of hyperoxia in pre-hospital settings. So far, despite the recognized urgent need for advancements in the management of oxygen delivery during early ROSC, studies have been exclusively retrospective and interventional studies failed to safely titrate oxygen in the prehospital context possibly due to lack of technological support7. The aim of investigator's is therefore to determine whether technological advances can allow for a safer and more accurate delivery of oxygen in the early ROSC of OHCA, reducing ROS damage. Further research should then, if our hypothesis would be confirmed, reproduce the data in different settings and further investigate whether better oxygen administration during early ROSC improves patients' outcome.
Patient showing a sustained ROSC after an OHCA will be monitored according to current hospital protocols during pre-hospital transport. In addition to traditional monitoring patients will all be monitored with a Masimo device allowing continuous non-invasive measurement of ORI. Patients will be randomly assigned to blinded measurement of ORI (not allowing the clinician to visualize collected information through additional monitoring) or bi-modal monitoring (allowing the clinician to gather information both form traditional monitoring and from additional monitoring showing ORI values). In the latter case clinicians participant will be encouraged to target an ORI lower than 0.5 together with a SatO2>91%. In case of blinded measurement of ORI clinicians will manage ventilation according to standard SatO2 targets (94-98%). Ventilator settings in both groups will be managed in order to target an end-tidal CO2 (ETCO2) between 35 and 45mmHg.
An arterial blood sample and a central body temperature will be taken at hospital admission.
The arterial blood sample will be analysed for glucose, pH, PaCO2 and PaO2 and corrected for temperature in order to calculate dissolved oxygen.
A second blood sample will be done at 48h to measure NSE. A standardised form will be filled by the pre-hospital physician participant gathering information about no flow time, low flow time, first assessed rhythm, BMI, smoking habit and patient demographics.
- Conditions
- Out-Of-Hospital Cardiac Arrest, Oxygen Toxicity
- Being tested
- ORI measurement, oxygen saturation measurement
- Keywords
- hyperoxia, post rosc, oxygen reserve index, Fi02 titration, post cardiac arrest care, oxygen
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORI measurementDevice
Oxygen (FiO2) will be titrated according to ORI index and Oxygen saturation.
oxygen saturation measurementDevice
Oxygen (FiO2) will be titrated according to oxygen saturation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: oxygen saturation measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
DO=Kh x PaO2. Range are expected to be from 0 to 6. 6 is associating with a higher hyperoxia.
Measured: at date of randomisation from time of hospital admission up to 30 minutes after time of hospital admission
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
Measured: at date of randomisation from time of hospital admission up to 30 minutes after time of hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start8 Nov 2018
- Primary completion10 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized controlled study
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Brugmann, Masimo Corporation
- Responsible party
- Sponsor
- Investigators
- stefano Malinverni, Principal investigator, Centre Hospitalier Universitaire Saint Pierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653325
- Sponsor's protocol ID
- ORI one
- Acronym
- ORI-ONE
- Status last verified
- May 2022
- First submitted
- 17 Jul 2018
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: After publication all IPD inherent with the publication will be made available through the researchgate.com profile of the principal investigator
Publications
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.
PubMed 37863418
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Non-invasive Multi-wavelength Monitoring of Out of Hospital Cardiac Arrest Having a Sustained ROSC Reduce Hyperoxia and Hypoxia During Hospital Transfer
- ClinicalTrials.gov ID
- NCT03653325
- Acronym / sponsor ID
- ORI-ONE / ORI one
- Conditions
- Out-Of-Hospital Cardiac Arrest, Oxygen Toxicity
- Keywords
- hyperoxia, post rosc, oxygen reserve index, Fi02 titration, post cardiac arrest care, oxygen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Brugmann, Masimo Corporation
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Oxygen has a pivotal role in emergency medicine as a lifesaving therapy in numerous situations. In order to avoid hypoxia-related morbidity and mortality, oxygen is delivered in emergencies in a liberal way, even when hypoxia is not confirmed. Nevertheless, as every medication, experimental and clinical studies have highlighted potential side effects of high oxygen tension that could worsen outcome. Cardiac arrest is the archetypal situation given the urgent need of rapid oxygen delivery to organs. However, this global ischemia-reperfusion syndrome produces high amounts ROS that could magnify the damages of the ischemic period and might be significantly increased by high oxygen tension. Thus, hyperoxia in the post-resuscitation context of cardiac arrest is an important topic. Advances in noninvasive oxygen monitoring can now allow for non-invasive monitoring of hyperoxia in pre-hospital settings. So far, despite the recognized urgent need for advancements in the management of oxygen delivery during early ROSC, studies have been exclusively retrospective and interventional studies failed to safely titrate oxygen in the prehospital context possibly due to lack of technological support7. The aim of investigator's is therefore to determine whether technological advances can allow for a safer and more accurate delivery of oxygen in the early ROSC of OHCA, reducing ROS damage. Further research should then, if our hypothesis would be confirmed, reproduce the data in different settings and further investigate whether better oxygen administration during early ROSC improves patients' outcome.
Patient showing a sustained ROSC after an OHCA will be monitored according to current hospital protocols during pre-hospital transport. In addition to traditional monitoring patients will all be monitored with a Masimo device allowing continuous non-invasive measurement of ORI. Patients will be randomly assigned to blinded measurement of ORI (not allowing the clinician to visualize collected information through additional monitoring) or bi-modal monitoring (allowing the clinician to gather information both form traditional monitoring and from additional monitoring showing ORI values). In the latter case clinicians participant will be encouraged to target an ORI lower than 0.5 together with a SatO2>91%. In case of blinded measurement of ORI clinicians will manage ventilation according to standard SatO2 targets (94-98%). Ventilator settings in both groups will be managed in order to target an end-tidal CO2 (ETCO2) between 35 and 45mmHg.
An arterial blood sample and a central body temperature will be taken at hospital admission.
The arterial blood sample will be analysed for glucose, pH, PaCO2 and PaO2 and corrected for temperature in order to calculate dissolved oxygen.
A second blood sample will be done at 48h to measure NSE. A standardised form will be filled by the pre-hospital physician participant gathering information about no flow time, low flow time, first assessed rhythm, BMI, smoking habit and patient demographics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| interventional arm | Experimental | Device: ORI measurement, Device: oxygen saturation measurementIn 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. |
| Observational arm | Active comparator | Device: oxygen saturation measurementObservational 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- out hospital cardiac arrest
- non traumatic etiology
- ROSC achieved
Key exclusion criteria (4 listed)
- less 18 year
- traumatic etiology
- prisonnier
- pregnant woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ORI measurementOxygen (FiO2) will be titrated according to ORI index and Oxygen saturation. | Device | interventional arm |
| oxygen saturation measurementOxygen (FiO2) will be titrated according to oxygen saturation | Device | Observational arm, interventional arm |
Primary outcome
normoxia index
Time frame: at date of randomisation, from Time of randomisation at ROSC up to time of hospital admission.
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.
2 secondary outcomes
Dissolved Oxygen in admission Blood gas sample (DO)
Time frame: at date of randomisation from time of hospital admission up to 30 minutes after time of hospital admission
PaO2 in admission blood gas sample
Time frame: at date of randomisation from time of hospital admission up to 30 minutes after time of hospital admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Derived from this study: PubMed 37863418Malinverni 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.
- Individual participant dataSharing planned: Yes. After publication all IPD inherent with the publication will be made available through the researchgate.com profile of the principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
stefano Malinverni principal investigator
Centre Hospitalier Universitaire Saint Pierre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ORI measurement and oxygen saturation measurement in people with Out-Of-Hospital Cardiac Arrest and Oxygen Toxicity, run by Centre Hospitalier Universitaire Saint Pierre at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
normoxia index (time frame: at date of randomisation, from Time of randomisation at ROSC up to time of hospital admission.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03653325, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.