NCT03128892

Oxygen Reserve Index Validation for RD Lite Sensors

Completed Results posted Last updated 1 March 2021

What this trial tests

trial testing Oxygen Reserve Index - RD Lite Sensors in Healthy in 34 participants. Completed in 29 March 2017.

Timeline

10 June 2016

Primary endpoint
29 March 2017

29 March 2017

Quick facts

Lead sponsor	Masimo Corporation
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	34
Start date	10 June 2016
Primary completion	29 March 2017
Estimated completion	29 March 2017
Sites	1 location across United States

Drugs / interventions tested

• Oxygen Reserve Index - RD Lite Sensors

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Masimo Corporation — full company profile →

Who can join

Adults 18 to 50, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Specificity of ORI to Detect Drops in Oxygenation Primary · 1-5 hours per subject

A measure of the ORI parameter's ability to detect changes in dissolved oxygen levels in blood plasma. Specificity, as measured in this outcome, is the probability of ORI not dropping when there is no drop in blood oxygen levels (desaturation).

PaO2 Threshold: 110 mmHg

Group	Value	95% CI
Oxygen Reserve Index (ORi) - RD Lite Sensors	98.50

PaO2 Threshold: 120 mmHg

Group	Value	95% CI
Oxygen Reserve Index (ORi) - RD Lite Sensors	96.68

PaO2 Threshold: 130 mmHg

Group	Value	95% CI
Oxygen Reserve Index (ORi) - RD Lite Sensors	98.89

PaO2 Threshold: 140 mmHg

Group	Value	95% CI
Oxygen Reserve Index (ORi) - RD Lite Sensors	96.95

PaO2 Threshold: 150 mmHg

Group	Value	95% CI
Oxygen Reserve Index (ORi) - RD Lite Sensors	97.67

PaO2 Threshold: 160 mmHg

Group	Value	95% CI
Oxygen Reserve Index (ORi) - RD Lite Sensors	94.75

PaO2 Threshold: 170 mmHg

Group	Value	95% CI
Oxygen Reserve Index (ORi) - RD Lite Sensors	93.60

PaO2 Threshold: 180 mmHg

Group	Value	95% CI
Oxygen Reserve Index (ORi) - RD Lite Sensors	96.23

Sensitivity of ORI to Detect Drops in Oxygenation Primary · 1-5 hours

A measure of the ORI parameter's ability to detect changes in dissolved oxygen levels in blood plasma. Sensitivity, as measured in this outcome, is the probability of ORI dropping when there is a drop in blood oxygenation levels (desaturation).

PaO2 Threshold: 110 mmHg

Group	Value	95% CI
Oxygen Reserve Index (ORi) - RD Lite Sensors	84.96

PaO2 Threshold: 120 mmHg

Group	Value	95% CI
Oxygen Reserve Index (ORi) - RD Lite Sensors	89.85

PaO2 Threshold: 130 mmHg

Group	Value	95% CI
Oxygen Reserve Index (ORi) - RD Lite Sensors	85.51

PaO2 Threshold: 140 mmHg

Group	Value	95% CI
Oxygen Reserve Index (ORi) - RD Lite Sensors	89.47

PaO2 Threshold: 150 mmHg

Group	Value	95% CI
Oxygen Reserve Index (ORi) - RD Lite Sensors	86.17

PaO2 Threshold: 160 mmHg

Group	Value	95% CI
Oxygen Reserve Index (ORi) - RD Lite Sensors	87.13

PaO2 Threshold: 170 mmHg

Group	Value	95% CI
Oxygen Reserve Index (ORi) - RD Lite Sensors	83.96

PaO2 Threshold: 180 mmHg

Group	Value	95% CI
Oxygen Reserve Index (ORi) - RD Lite Sensors	85.40

Concordance of ORI to Detect Drops in Oxygenation Primary · 1-5 hours

A measure of the ORI parameter's ability to detect changes in dissolved oxygen levels in blood plasma. Concordance, as measured in this outcome, is the probability of ORI to respond accurately to changes (or lack of thereof) in underlying blood oxygenation levels. It is computed as a ratio of true classifications (true positives and true negatives) to the sample size. An ideal detector will have a concordance value of 1 (or 100%).

PaO2 Threshold: 110 mmHg

Group	Value	95% CI
Oxygen Reserve Index (ORi) - RD Lite Sensors	88.83

PaO2 Threshold: 120 mmHg

Group	Value	95% CI
Oxygen Reserve Index (ORi) - RD Lite Sensors	92.46

PaO2 Threshold: 130 mmHg

Group	Value	95% CI
Oxygen Reserve Index (ORi) - RD Lite Sensors	91.47

PaO2 Threshold: 140 mmHg

Group	Value	95% CI
Oxygen Reserve Index (ORi) - RD Lite Sensors	93.33

PaO2 Threshold: 150 mmHg

Group	Value	95% CI
Oxygen Reserve Index (ORi) - RD Lite Sensors	93.00

PaO2 Threshold: 160 mmHg

Group	Value	95% CI
Oxygen Reserve Index (ORi) - RD Lite Sensors	92.16

PaO2 Threshold: 170 mmHg

Group	Value	95% CI
Oxygen Reserve Index (ORi) - RD Lite Sensors	90.80

PaO2 Threshold: 180 mmHg

Group	Value	95% CI
Oxygen Reserve Index (ORi) - RD Lite Sensors	93.78

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 to 5 hours. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Oxygen Reserve Index (ORi) - RD Lite Sensors

Serious: 0/34 (0%)

Deaths: 0/34

Other adverse events (1 terms — click to expand)

Reaction	System	Oxygen Reserve Index (ORi)…
Arterial line site sensitivity	Surgical and medical procedures	—

Data from ClinicalTrials.gov NCT03128892 adverse events section.

Sponsor's own description

Oxygen Reserve Index (ORI) is a parameter that provides information on arterial partial pressure of oxygen (PaO2). In this study, the PaO2 is varied by controlling the concentration of oxygen the study volunteer breathes. The ORI device measurement is analyzed by comparing it to the PaO2 measurements from a laboratory analyzer.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.