Trial Outcomes & Findings for Wireless Disposable SpO2 Sensor Hypoxia Testing (NCT NCT06211530)

NCT ID: NCT06211530

Last Updated: 2025-04-30

Results Overview

The collection of SpO2 percentage sensor data with simultaneous transfer standard SpO2 percentage measurements (simulating blood sample SpO2) from each subject enrolled in the study.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 32 participants
• Primary outcome timeframe: 2 Weeks
• Results posted on: 2025-04-30

Participant Flow

A total of 32 participants were enrolled; 31 subjects completed all study procedures.

Participant milestones

Measure	SpO2 Measurements - All Subjects Participants participating in this study will be connected to eight (8) Portrait Mobile P-SA01PL/P-SP01PL prototype sensors provided by GEHC and two reference monitors, Nellcor N-600X V 1.6.0.0 and a forehead sensor, used as standard operating procedures at the site. Data will be collected using the Portrait Hub patient monitor. The participants are exposed to a desaturation protocol that sequentially decreases the SpO2 in a stepwise fashion. The goal is to achieve six stable oxygenation plateaus between 100 and 70% SpO2, while recording simultaneous SpO2 readings from the prototype and reference devices. The protocol is consistent with the ISO 80601-2-61 pulse oximetry standard. SpO2 Sensor Testing: Participants participating in this study will be connected to eight (8) Portrait Mobile P-SA01PL/P-SP01PL prototype sensors provided by GEHC and two reference monitors, Nellcor N-600X V 1.6.0.0 and a forehead sensor, used as standard operating procedures at the site. Data will be collected using the Portrait Hub patient monitor. The participants are exposed to a desaturation protocol that sequentially decreases the SpO2 in a stepwise fashion. The goal is to achieve six stable oxygenation plateaus between 100 and 70% SpO2, while recording simultaneous SpO2 readings from the prototype and reference devices. The protocol is consistent with the ISO 80601-2-61 pulse oximetry standard.
Overall Study STARTED	32
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Wireless Disposable SpO2 Sensor Hypoxia Testing

Baseline characteristics by cohort

Measure	SpO2 Measurements - All Subjects n=31 Participants Participants participating in this study will be connected to sensors. The participants are exposed to a desaturation protocol. The protocol is consistent with the ISO 80601-2-61 pulse oximetry standard.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	28.42 years STANDARD_DEVIATION 8.83 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants
Skin Pigment Monk 01 (Lightest Skin Tone)	4 Participants n=5 Participants
Skin Pigment Monk 02	4 Participants n=5 Participants
Skin Pigment Monk 03	1 Participants n=5 Participants
Skin Pigment Monk 04	2 Participants n=5 Participants
Skin Pigment Monk 05	5 Participants n=5 Participants
Skin Pigment Monk 06	2 Participants n=5 Participants
Skin Pigment Monk 07	2 Participants n=5 Participants
Skin Pigment Monk 08	7 Participants n=5 Participants
Skin Pigment Monk 09	2 Participants n=5 Participants
Skin Pigment Monk 10 (Darkest Skin Tone)	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 Weeks

The collection of SpO2 percentage sensor data with simultaneous transfer standard SpO2 percentage measurements (simulating blood sample SpO2) from each subject enrolled in the study.

Outcome measures

Measure	SpO2 Measurements - All Subjects n=31 Participants Subjects participating in this study will be connected to SpO2 sensors. The participants are exposed to a desaturation protocol. The protocol is consistent with the ISO 80601-2-61 pulse oximetry standard.
Collection of Subject SpO2 Percentage Sensor Data With Transfer Standard Measurements for Validation	31 data sets

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 Weeks

The collection of the number of adverse events, serious adverse events, and/or device deficiencies reported on all enrolled subjects in the study.

Outcome measures

Measure	SpO2 Measurements - All Subjects n=31 Participants Subjects participating in this study will be connected to SpO2 sensors. The participants are exposed to a desaturation protocol. The protocol is consistent with the ISO 80601-2-61 pulse oximetry standard.
Number of Safety Events Adverse Event	1 safety events
Number of Safety Events Serious Adverse Event	1 safety events

Adverse Events

Collection of Adverse Events

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Collection of Adverse Events n=32 participants at risk Collection of all information, including type and number of AEs, SAEs, and device issues.
Cardiac disorders SAE	3.1% 1/32 • Number of events 1 • 2 Weeks All adverse events (AE), including all serious adverse events (SAE), are required to be collected, investigated, and documented. AEs will be collected from \[describe the reporting period, e.g., from the time they enter the scan room to the time they leave the scan room\]. All AEs will be followed through to their resolution.

Other adverse events

Measure	Collection of Adverse Events n=32 participants at risk Collection of all information, including type and number of AEs, SAEs, and device issues.
Cardiac disorders AE	3.1% 1/32 • Number of events 1 • 2 Weeks All adverse events (AE), including all serious adverse events (SAE), are required to be collected, investigated, and documented. AEs will be collected from \[describe the reporting period, e.g., from the time they enter the scan room to the time they leave the scan room\]. All AEs will be followed through to their resolution.

Additional Information

Principal Engineer

GE HealthCare

Phone: +358 (40) 7755194

Email: 100012917@gehealthcare.com

Results disclosure agreements

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