IntubationFiO2RINCT05085119
Validation of the Relationship Between Oxygenation Parameters and ORI™, in Mechanically Ventilated ICU Patients
A study testing Stepwise modifications of FiO2 in people with Intubation and Mechanical Ventilation, run by University Hospital, Clermont-Ferrand at 2 sites in France.
Trial summary
The ORI™ or Oxygen Reserve Index (Masimo, Irvine, CA, USA) is a non-invasive monitoring system for measuring oxygen reserve. It is a digital sensor (almost identical to the SpO2 sensor) which allows an analysis of the absorption of arterial, venous and capillary components. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation, Mechanical Ventilation, Intensive Care Unit
- What is being tested?
- Stepwise modifications of FiO2
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- 9 Feb 2021to 10 Aug 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
- Patients aged over 18 years, admitted in an intensive care unit of the Peri-Operative Medicine Pole of the Clermont-Ferrand University Hospital, under invasive mechanical ventilation (intubation or tracheotomy), whose FiO2 required to obtain an SpO2 > 95% is ≤ 30%, equipped as part of routine care with an arterial catheter and a central venous catheter in the superior vena cava territory
- BMI < 30 kg.m-2
- Written consent to participate in the study by the patient or by the trusted person, or the relative if he or she is present.
Who cannot join
- Existence of an underlying pulmonary pathology that may alter oxygen diffusion or generate an intra-pulmonary shunt (COPD, emphysema, pneumopathy, ARDS, chronic respiratory failure...)
- Uncontrolled haemodynamic instability defined by an increase of more than 20% in catecholamine dosages during the last hour, despite optimisation of the blood volume according to a pre-established protocol (mini-fluid challenge)
- Patient already included in the study
- Patient's or relative's refusal to participate
- Guardianship or trusteeship patient
- No affiliation to the Social Security system
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clermont-Ferrand University Hospital
Clermont-Ferrand, 63000
CHU
Clermont-Ferrand
About this study
Official title: Validation of the Relationship Between Oxygenation Parameters and the Oxygen Reserve Index (ORI™), in Mechanically Ventilated ICU Patients: An Exploratory Pathophysiology Study
The ORI™ or Oxygen Reserve Index (Masimo, Irvine, CA, USA) is a non-invasive monitoring system for measuring oxygen reserve. It is a digital sensor (almost identical to the SpO2 sensor) which allows an analysis of the absorption of arterial, venous and capillary components. The measured index, unitless, ranges from 0.00 to 1.00 for moderate hyperoxia levels: from 100 to 200 mmHg. It can alert the clinician to a drop in oxygen stores via the drop in SvO2 before a drop in SpO2 is observed. We propose to carry out a study to elucidate correlation between ORI™ and PaO2.
Read the detailed description
Pulse oximetry or SpO2 is the standard and mandatory monitoring of oxygenation during mechanical ventilation of intensive care and operating theatre patients. Its use is based on the difference in infrared and red light absorptions of oxyhaemoglobin and reduced haemoglobin. The calculation of the absorption percentage takes into account the pulsatility of the signal, reflecting the arterial component, while eliminating the continuous signal, reflecting the venous component. It is then considered that SpO2 is a reflection of SaO2, or arterial oxygen saturation. Oxygen exists in two forms in the arterial circulation: dissolved (PaO2) or bound to haemoglobin (SaO2).
Because of the sigmoidal shape of the oxyhaemoglobin dissociation curve, SpO2 is a late marker of arterial hypoxaemia. Indeed, SpO2 only starts to decrease after a marked drop in PaO2.
Hypoxaemia is a frequent situation, both in the operating theatre during the period of securing the airway, intra-operatively, or post-operatively, after extubation, on episodes of alveolar hypoventilation, such as atelectasis. In intensive care units, it can occur in injured lungs with various aetiologies (infectious, inflammatory, cardiac, etc). It is an independent predictive factor of mortality.
Exposure of patients to high hyperoxia (FiO2>0.7), over a long period of time, can lead to pulmonary endothelial damage (due to the formation of reactive oxygen species, ROS), denitrogenation atelectasis, and possibly a systemic inflammatory cascade. It is currently suggested that hyperoxia may also have a haemodynamic impact, with a fall in cardiac output and peripheral vasoconstriction, particularly in healthy volunteers and patients with cardiac decompensation. However, hyperoxia is a frequent situation during the perioperative period as it provides safety and a potential oxygen reserve in case of adverse events: hemodynamic degradation, cardiac arrest, extubation...
The ORI™ or Oxygen Reserve Index (Masimo, Irvine, CA, USA) is a non-invasive monitoring system for measuring oxygen reserve. It is a digital sensor (almost identical to the SpO2 sensor) which allows an analysis of the absorption of arterial, venous and capillary components. The measured index, unitless, ranges from 0.00 to 1.00 for moderate hyperoxia levels: from 100 to 200 mmHg. It can alert the clinician to a drop in oxygen stores via the drop in SvO2 before a drop in SpO2 is observed.
There is little literature on ORI™. A previous study showed a poor correlation between ORI™ (ranging from 0.24 to 0.55) and PaO2, which ranged from 100 to 150 mmHg, respectively. The company, Masimo, has recently made a change in its algorithm, allowing it to re-calibrate its sensor. However, no new correlation research has been conducted. We therefore propose to carry out a new test phase.
- Conditions
- Intubation, Mechanical Ventilation, Intensive Care Unit
- Being tested
- Stepwise modifications of FiO2
- Keywords
- Oxygen administration, Oxygen blood content, ORI, Intensive care unit, ICU, Mechanical ventilation, Intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepwise modifications of FiO2Procedure or surgery
FiO2 will be increased stepwise from 30 to 100% (40, 60 and 80%), and then decreased with the same FiO2 reverse steps.
| Study group | Role | What they receive |
|---|---|---|
| FiO2 stepwise modifications | Experimental | Intubation ICU patients will be challenged with stepwise modifications of FiO2. The following steps will be done: 30, 40, 60, 80, 100, 80, 60, 40 and 30%. Receives: Procedure: Stepwise modifications of FiO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between ORI™ and PaO2
Correlations will be investigated during the last minute of each 10 minutes FiO2 steps
Measured: There will be nine 10 minutes steps. Measurement will be done during the last minute of each 10 minutes step
Secondary outcomes (4)
Correlation between ORI™ and PcvO2
Correlations will be investigated during the last minute of each 10 minutes FiO2 steps
Measured: There will be nine 10 minutes steps. Measurement will be done during the last minute of each 10 minutes step
Correlation between ORI™ and ScvO2
Correlations will be investigated during the last minute of each 10 minutes FiO2 steps
Measured: There will be nine 10 minutes steps. Measurement will be done during the last minute of each 10 minutes step
Correlation between ORI™ and SaO2
Correlations will be investigated during the last minute of each 10 minutes FiO2 steps
Measured: There will be nine 10 minutes steps. Measurement will be done during the last minute of each 10 minutes step
Correlation between ORI™ and SpO2
Correlations will be investigated during the last minute of each 10 minutes FiO2 steps
Measured: There will be nine 10 minutes steps. Measurement will be done during the last minute of each 10 minutes step
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start9 Feb 2021
- Primary completion10 Aug 2022
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntubationStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Validation study of a non-invasive sensor-type medical device, with comparison to standard paraclinical parameters, with a stepwise modification test of FIO2, in normo- to moderate hyperoxic conditions.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Godet, MD, PhD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085119
- Sponsor's protocol ID
- RBHP 2019 GODET 3
- Acronym
- FiO2RI
- Status last verified
- Feb 2023
- First submitted
- 15 Sep 2021
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Relationship Between Oxygenation Parameters and the Oxygen Reserve Index (ORI™), in Mechanically Ventilated ICU Patients: An Exploratory Pathophysiology Study
- ClinicalTrials.gov ID
- NCT05085119
- Acronym / sponsor ID
- FiO2RI / RBHP 2019 GODET 3
- Conditions
- Intubation, Mechanical Ventilation, Intensive Care Unit
- Keywords
- Oxygen administration, Oxygen blood content, ORI, Intensive care unit, ICU, Mechanical ventilation, Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 20 Oct 2021 (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 ORI™ or Oxygen Reserve Index (Masimo, Irvine, CA, USA) is a non-invasive monitoring system for measuring oxygen reserve. It is a digital sensor (almost identical to the SpO2 sensor) which allows an analysis of the absorption of arterial, venous and capillary components. The measured index, unitless, ranges from 0.00 to 1.00 for moderate hyperoxia levels: from 100 to 200 mmHg. It can alert the clinician to a drop in oxygen stores via the drop in SvO2 before a drop in SpO2 is observed. We propose to carry out a study to elucidate correlation between ORI™ and PaO2.
Detailed description
Pulse oximetry or SpO2 is the standard and mandatory monitoring of oxygenation during mechanical ventilation of intensive care and operating theatre patients. Its use is based on the difference in infrared and red light absorptions of oxyhaemoglobin and reduced haemoglobin. The calculation of the absorption percentage takes into account the pulsatility of the signal, reflecting the arterial component, while eliminating the continuous signal, reflecting the venous component. It is then considered that SpO2 is a reflection of SaO2, or arterial oxygen saturation. Oxygen exists in two forms in the arterial circulation: dissolved (PaO2) or bound to haemoglobin (SaO2).
Because of the sigmoidal shape of the oxyhaemoglobin dissociation curve, SpO2 is a late marker of arterial hypoxaemia. Indeed, SpO2 only starts to decrease after a marked drop in PaO2.
Hypoxaemia is a frequent situation, both in the operating theatre during the period of securing the airway, intra-operatively, or post-operatively, after extubation, on episodes of alveolar hypoventilation, such as atelectasis. In intensive care units, it can occur in injured lungs with various aetiologies (infectious, inflammatory, cardiac, etc). It is an independent predictive factor of mortality.
Exposure of patients to high hyperoxia (FiO2>0.7), over a long period of time, can lead to pulmonary endothelial damage (due to the formation of reactive oxygen species, ROS), denitrogenation atelectasis, and possibly a systemic inflammatory cascade. It is currently suggested that hyperoxia may also have a haemodynamic impact, with a fall in cardiac output and peripheral vasoconstriction, particularly in healthy volunteers and patients with cardiac decompensation. However, hyperoxia is a frequent situation during the perioperative period as it provides safety and a potential oxygen reserve in case of adverse events: hemodynamic degradation, cardiac arrest, extubation...
The ORI™ or Oxygen Reserve Index (Masimo, Irvine, CA, USA) is a non-invasive monitoring system for measuring oxygen reserve. It is a digital sensor (almost identical to the SpO2 sensor) which allows an analysis of the absorption of arterial, venous and capillary components. The measured index, unitless, ranges from 0.00 to 1.00 for moderate hyperoxia levels: from 100 to 200 mmHg. It can alert the clinician to a drop in oxygen stores via the drop in SvO2 before a drop in SpO2 is observed.
There is little literature on ORI™. A previous study showed a poor correlation between ORI™ (ranging from 0.24 to 0.55) and PaO2, which ranged from 100 to 150 mmHg, respectively. The company, Masimo, has recently made a change in its algorithm, allowing it to re-calibrate its sensor. However, no new correlation research has been conducted. We therefore propose to carry out a new test phase.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Validation study of a non-invasive sensor-type medical device, with comparison to standard paraclinical parameters, with a stepwise modification test of FIO2, in normo- to moderate hyperoxic conditions.
| Arm | Type | Receives |
|---|---|---|
| FiO2 stepwise modifications | Experimental | Procedure: Stepwise modifications of FiO2Intubation ICU patients will be challenged with stepwise modifications of FiO2. The following steps will be done: 30, 40, 60, 80, 100, 80, 60, 40 and 30%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged over 18 years, admitted in an intensive care unit of the Peri-Operative Medicine Pole of the Clermont-Ferrand University Hospital, under invasive mechanical ventilation (intubation or tracheotomy), whose FiO2 required to obtain an SpO2 > 95% is ≤ 30%, equipped as part of routine care with an arterial catheter and a central venous catheter in the superior vena cava territory
- BMI < 30 kg.m-2
- Written consent to participate in the study by the patient or by the trusted person, or the relative if he or she is present.
Key exclusion criteria (6 listed)
- Existence of an underlying pulmonary pathology that may alter oxygen diffusion or generate an intra-pulmonary shunt (COPD, emphysema, pneumopathy, ARDS, chronic respiratory failure...)
- Uncontrolled haemodynamic instability defined by an increase of more than 20% in catecholamine dosages during the last hour, despite optimisation of the blood volume according to a pre-established protocol (mini-fluid challenge)
- Patient already included in the study
- Patient's or relative's refusal to participate
- Guardianship or trusteeship patient
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 |
|---|---|---|
| Stepwise modifications of FiO2FiO2 will be increased stepwise from 30 to 100% (40, 60 and 80%), and then decreased with the same FiO2 reverse steps. | Procedure or surgery | FiO2 stepwise modifications |
Primary outcome
Correlation between ORI™ and PaO2
Time frame: There will be nine 10 minutes steps. Measurement will be done during the last minute of each 10 minutes step
Correlations will be investigated during the last minute of each 10 minutes FiO2 steps
4 secondary outcomes
Correlation between ORI™ and PcvO2
Time frame: There will be nine 10 minutes steps. Measurement will be done during the last minute of each 10 minutes step
Correlation between ORI™ and ScvO2
Time frame: There will be nine 10 minutes steps. Measurement will be done during the last minute of each 10 minutes step
Correlation between ORI™ and SaO2
Time frame: There will be nine 10 minutes steps. Measurement will be done during the last minute of each 10 minutes step
Correlation between ORI™ and SpO2
Time frame: There will be nine 10 minutes steps. Measurement will be done during the last minute of each 10 minutes step
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 17 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
Thomas Godet, MD, PhD principal investigator
University Hospital, Clermont-Ferrand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepwise modifications of FiO2 in people with Intubation and Mechanical Ventilation, run by University Hospital, Clermont-Ferrand at 2 sites in France.
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 6 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 17 Feb 2023. 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 France. 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?
Correlation between ORI™ and PaO2 (time frame: There will be nine 10 minutes steps. Measurement will be done during the last minute of each 10 minutes step). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.