Trial Outcomes & Findings for U-TruSignal SpO2 Testing in Neonates (NCT NCT03383757)

Results Overview

Compare observations of Peripheral Capillary Oxygen Saturation (SpO2- measured by the test pulse oximeter system) and Oxygen Saturation of Arterial Blood (SaO2) values (measured by CO-Oximeter analysis of simultaneous drawn arterial blood).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

117 participants

Primary outcome timeframe

30 minutes per data pair

Results posted on

2020-12-04

Participant Flow

Participant milestones

Participant milestones
Measure	SpO2 Sensor Application & Blood Draw All subjects will undergo the same study procedures of having their SpO2 levels measured with an external sensor applied to the skin and blood SpO2 level measured. Subject may have one or both sensors applied. SpO2 Sensor application \& blood draw: At the start of the procedure, one to two commercial sensors shall be applied to the subject. Readings will be allowed to stabilize. After at least 10 minutes of data collection, arterial blood will be collected and analyzed blood per hospital's standard procedure. Data collection will continue post blood draw for two minutes.
Overall Study STARTED	117
Overall Study TruSignal AllFit Sensor Subjects	56
Overall Study TruSignal Sensitive Sensor Subjects	59
Overall Study TruSignal AllFit Sensor Data Pairs	52
Overall Study TruSignal Sensitive Sensor Data Pairs	51
Overall Study COMPLETED	78
Overall Study NOT COMPLETED	39

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SpO2 Sensor Application & Blood Draw n=78 Participants All subjects will undergo the same study procedures of having their SpO2 levels measured with an external sensor applied to the skin and blood SpO2 level measured SpO2 Sensor application \& blood draw: At the start of the procedure, one to two commercial sensors shall be applied to the subject. Readings will be allowed to stabilize. After at least 10 minutes of data collection, arterial blood will be collected and analyzed blood per hospital's standard procedure. Data collection will continue post blood draw for two minutes.
Age, Customized Age	5.2 days STANDARD_DEVIATION 4.34 • n=78 Participants
Sex: Female, Male Female	36 Participants n=78 Participants
Sex: Female, Male Male	42 Participants n=78 Participants

PRIMARY outcome

Timeframe: 30 minutes per data pair

Population: Participants may have multiple data points with multiple sensors.

Compare observations of Peripheral Capillary Oxygen Saturation (SpO2- measured by the test pulse oximeter system) and Oxygen Saturation of Arterial Blood (SaO2) values (measured by CO-Oximeter analysis of simultaneous drawn arterial blood).

Outcome measures

Outcome measures
Measure	SpO2 Sensor Application & Blood Draw n=78 Participants All subjects will undergo the same study procedures of having their SpO2 levels measured with an external sensor applied to the skin and blood SpO2 level measured SpO2 Sensor application \& blood draw: At the start of the procedure, one to two commercial sensors shall be applied to the subject. Readings will be allowed to stabilize. After at least 10 minutes of data collection, arterial blood will be collected and analyzed blood per hospital's standard procedure. Data collection will continue post blood draw for two minutes.
Accuracy Root Mean Square (ARMS) Per Data Pair TS-AF ARMS	2.57 percentage of oxygen saturated hemoglobi
Accuracy Root Mean Square (ARMS) Per Data Pair TS-SE ARMS	2.57 percentage of oxygen saturated hemoglobi

SECONDARY outcome

Timeframe: 30 minutes per data pair

Population: 78 Participants analyzed, 38 with TS-AF sensor, 40 with TS-SE sensor. Participants may have multiple data points with multiple sensors.

The secondary objective of the study was to demonstrate U-TruSignal collects substantially continuous SpO2 measurements during a data collection interval. All time the sensors were worn and data collected across participants were reviewed for invalid data within each data pair. For the data pairs that had moments of invalid data, a calculation was conducted (invalid data/complete data for data pair) to establish percentage of invalid data per sensor. For each sensor type the percentage of invalid data (%) was calculated. Sensor readings were grouped together across participants and are being reported as the total number of invalid readings over the total number of readings for all participants

Outcome measures

Outcome measures
Measure	SpO2 Sensor Application & Blood Draw n=78 Participants All subjects will undergo the same study procedures of having their SpO2 levels measured with an external sensor applied to the skin and blood SpO2 level measured SpO2 Sensor application \& blood draw: At the start of the procedure, one to two commercial sensors shall be applied to the subject. Readings will be allowed to stabilize. After at least 10 minutes of data collection, arterial blood will be collected and analyzed blood per hospital's standard procedure. Data collection will continue post blood draw for two minutes.
Continuous SpO2 Measurements During Data Collection Interval TS-AF <=1% of invalid data	38 Participants
Continuous SpO2 Measurements During Data Collection Interval TS-AF >1% of invalid data	0 Participants
Continuous SpO2 Measurements During Data Collection Interval TS-SE <=1% of invalid data	40 Participants
Continuous SpO2 Measurements During Data Collection Interval TS-SE >1% of invalid data	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 minutes per data pair

Population: AE, SAE and Device Issues were measured for each sensor.

Collect safety information, including type and number of AE s, SAEs, and device issues.

Outcome measures

Outcome measures
Measure	SpO2 Sensor Application & Blood Draw n=78 Participants All subjects will undergo the same study procedures of having their SpO2 levels measured with an external sensor applied to the skin and blood SpO2 level measured SpO2 Sensor application \& blood draw: At the start of the procedure, one to two commercial sensors shall be applied to the subject. Readings will be allowed to stabilize. After at least 10 minutes of data collection, arterial blood will be collected and analyzed blood per hospital's standard procedure. Data collection will continue post blood draw for two minutes.
Type and Number of AEs, SAEs, and Device Issues TruSignal AllFit Sensor AE	0 Events
Type and Number of AEs, SAEs, and Device Issues TruSignal AllFit Sensor SAE	0 Events
Type and Number of AEs, SAEs, and Device Issues TruSignal AllFit Sensor Device Issues	0 Events
Type and Number of AEs, SAEs, and Device Issues TruSignal Sensitive Sensor AE	0 Events
Type and Number of AEs, SAEs, and Device Issues TruSignal Sensitive Sensor SAE	0 Events
Type and Number of AEs, SAEs, and Device Issues TruSignal Sensitive Sensor Device Issues	0 Events

Adverse Events

SpO2 Sensor Application & Blood Draw

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Affairs Project Manager

GE Healthcare

Phone: 262-443-7008

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place