NCT03678103

Oxygen Reserve Index (ORi) Validation of INVSENSOR00029

Completed Results posted Last updated 30 September 2021

What this trial tests

trial testing INVSENSOR00029 in Healthy in 57 participants. Completed in 13 September 2018.

Timeline

29 August 2018

Primary endpoint
13 September 2018

13 September 2018

Quick facts

Lead sponsor	Masimo Corporation
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	57
Start date	29 August 2018
Primary completion	13 September 2018
Estimated completion	13 September 2018
Sites	1 location across United States

Drugs / interventions tested

• INVSENSOR00029

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.

Sensitivity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. Primary · 1-5 hours

ORi is an index value without a unit. Sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2 at 150 mmHg.

Group	Value	95% CI
Test Subject	93.63

Specificity for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values. Primary · 1-5 hours

ORi is an index value without a unit. Sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2 at 150 mmHg.

Group	Value	95% CI
Test Subject	86.96

Corcordance for Changes in ORi Values as Compared to Corresponding Changes in PaO2 Values Primary · 1-5 hours

ORi is an index value without a unit. Sensitivity, specificity, and concordance are calculated to evaluate changes in ORi relative to the changes in PaO2 at 150 mmHg.

Group	Value	95% CI
Test Subject	90.59

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.

Test Subject

Serious: 0/30 (0%)

Deaths: 0/30

Other adverse events (2 terms — click to expand)

Reaction	System	Test Subject
Sensitivity at arterial line site	Surgical and medical procedures	—
Vasovagal	Surgical and medical procedures	—

Data from ClinicalTrials.gov NCT03678103 adverse events section.

Sponsor's own description

ORi is a unitless index that could help clinicians with their assessments or 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. In this study, the PaO2 is varied by controlling the concentration of oxygen the study volunteer breathes. Changes in ORi values are analyzed by comparing it to corresponding changes in PaO2 measurements from blood samples.

Publications & conference data

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