An interventional study of ORi sensor in Hyperoxia, sponsored by Masimo Corporation. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-20.
Sponsored by Masimo Corporation (part of Danaher Corporation) · Interventional and Other
The Oxygen Reserve Index (ORi) is a reference that could help clinicians with their assessments of normoxic and hyperoxic states by scaling the measured absorption information between 0.00 and 1.00. An ORi of 0.00 corresponds to PaO2 values of 100mmHg and below and an ORi of 1.00 corresponds to PaO2 values of 200mmHg and above. This is a prospective, non-blinded, non-randomized study of the Oxygen Reserve Index (ORi) in a clinical setting. It is designed to evaluate the correlations with ORi and changes in PaO2 and the potential use of ORi as an early warning of impending arterial oxygen desaturation.
115 studies on the registry are indexed under Hyperoxia; 13 are open to participants now.
This study's enrollment of 31 is below the median of 48 across 82 interventional studies indexed under Hyperoxia.
Browse Hyperoxia studies →Masimo Corporation is the lead sponsor of 105 studies on the registry; 1 is open to participants now.
Of its 79 completed or terminated interventional studies of FDA-regulated products, 66 (84%) have results posted.
First submitted before Masimo Corporation became part of Danaher Corporation.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All subjects are enrolled in the test group and receive an ORi sensor during their scheduled, general surgery procedure
Device: ORi sensor
Noninvasive pulse oximeter sensor that is placed on the finger for measurement of ORi
Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore, sensitivity is calculated to evaluate changes in ORi relative to the changes in PaO2.
Time frame: Less than 30 mins
Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore specificity is calculated to evaluate changes in ORi relative to the changes in PaO2.
Time frame: Less than 30 mins
Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values.
ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore concordance is calculated to evaluate changes in ORi relative to the changes in PaO2.
Time frame: Less than 30 minutes
| Milestone | ORi Sensor |
|---|---|
| Started | 31 |
| Completed | 29 |
| Not completed | 2 |
| Withdrew: Equipment malfunction | 1 |
| Withdrew: Adverse event | 1 |
ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore, sensitivity is calculated to evaluate changes in ORi relative to the changes in PaO2.
| percentage of true positives | ORi Sensor |
|---|---|
| Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. | 100 |
ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore specificity is calculated to evaluate changes in ORi relative to the changes in PaO2.
| percentage of true negatives | ORi Sensor |
|---|---|
| Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. | 94.38 |
ORi is an index value without a unit and ORi does not directly measure PaO2. Therefore concordance is calculated to evaluate changes in ORi relative to the changes in PaO2.
| percentage of accuracy | ORi Sensor |
|---|---|
| Concordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. | 95.05 |
Collected over Less than 30 min. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ORi Sensor | 0/29 (0%) | 0/29 (0%) | 1/29 (3.4%) |
| Event | ORi Sensor |
|---|---|
| HypotensionInjury, poisoning and procedural complications | 1/29 |
| Age, Categorical(Participants) | ORi Sensor |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 11 |
| >=65 years | 18 |
| Sex: Female, Male(Participants) | ORi Sensor |
|---|---|
| Female | 12 |
| Male | 17 |
| Race and Ethnicity Not Collected(Participants) | ORi Sensor |
|---|
| Region of Enrollment(participants) | ORi Sensor |
|---|---|
| United States | 29 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Aug 2018 to primary completion in Sep 2018, 1 month.
Results were first posted in Sep 2021, 3 years after primary completion. A results delay was requested in Aug 2019.
Of 39 interventional studies with no phase under Hyperoxia, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 33. This study's 1 month is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.