Trial Outcomes & Findings for Accuracy of Pulse Oximeters With Profound Hypoxia At Rest (NIHO18) (NCT NCT05807464)

NCT ID: NCT05807464

Last Updated: 2025-09-12

Results Overview

Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter (SpO2i) to that obtained from a blood sample (SRi) and calculating the arithmetic root mean square (Arms) error value as follows: Arms =Square root (sum of n samples of ((SpO2i - SRi) squared) / n)

• Recruitment status: COMPLETED
• Target enrollment: 12 participants
• Primary outcome timeframe: 30 seconds
• Results posted on: 2025-09-12

Participant Flow

Participant milestones

Measure	Adult Healthy Subjects Adult healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile in an at rest state Pulse Oximeter: OLV-4202 pulse oximeter (SW version: 01-15)
Overall Study STARTED	12
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Adult Healthy Subjects Adult healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile in an at rest state Pulse Oximeter: OLV-4202 pulse oximeter (SW version: 01-15)
Overall Study Adverse Event	1

Baseline Characteristics

Accuracy of Pulse Oximeters With Profound Hypoxia At Rest (NIHO18)

Baseline characteristics by cohort

Measure	Adult Healthy Subjects n=11 Participants Adult healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile in an at rest state Pulse Oximeter: OLV-4202 pulse oximeter (SW version: 01-15)
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	5 Participants n=93 Participants
Sex: Female, Male Male	6 Participants n=93 Participants
Race/Ethnicity, Customized African	1 Participants n=93 Participants
Race/Ethnicity, Customized Caucasian	5 Participants n=93 Participants
Race/Ethnicity, Customized Asian	5 Participants n=93 Participants
Region of Enrollment United States	11 participants n=93 Participants

PRIMARY outcome

Timeframe: 30 seconds

Population: Qualified subjects

Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter (SpO2i) to that obtained from a blood sample (SRi) and calculating the arithmetic root mean square (Arms) error value as follows:

Arms =Square root (sum of n samples of ((SpO2i - SRi) squared) / n)

Outcome measures

Measure	Adult Healthy Subjects n=11 Participants Adult healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile in an at rest state Pulse Oximeter: OLV-4202 pulse oximeter (SW version: 01-15)
Accuracy of Sensor Oxygen Saturation by Arms Calculation	2.0 percentage of SpO2

SECONDARY outcome

Timeframe: 30 seconds

Population: Qualified subjects

Accuracy will be determined by comparing the noninvasive pulse rate measurement of the pulse oximeter (PRi) to the heart rate obtained from an electrocardiography reference device (HRRi) and calculating the arithmetic root mean square (Arms) error value as follows:

Arms =Square root (sum of n samples of ((PRi - HRRi) squared) / n)

Outcome measures

Measure	Adult Healthy Subjects n=11 Participants Adult healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile in an at rest state Pulse Oximeter: OLV-4202 pulse oximeter (SW version: 01-15)
Accuracy of Sensor Pulse Rate by Arms Calculation	2.0 percentage of SpO2

Adverse Events

Adult Healthy Subjects

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Adult Healthy Subjects n=12 participants at risk Adult healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile in an at rest state Pulse Oximeter: OLV-4202 pulse oximeter (SW version: 01-15)
Gastrointestinal disorders Nausea	8.3% 1/12 • Number of events 1 • 3 months

Additional Information

Dr. Philip Bickler

UCSF Hypoxia Research Laboratory

Phone: 1-415-476-1411

Email: philip.bickler@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place