U-TruSignal SpO2 Testing in Neonates

• Sponsor: GE Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03383757
• Collaborator: (none)
• Enrollment: 117
• Locations: 2
• Arm: 1
• Actual Duration (Months): 25.6
• Patients Per Site: 58.5
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

The purpose of the study is to demonstrate proper function of the U-TruSignal device via clinical performance testing in a neonatal human subject population under standard clinical conditions. A study with human subjects will provide the needed clinical evidence for assessing the accuracy of the pulse oximeter as recommended by the FDA Guidance Document (Pulse Oximeters - Premarket Notification Submissions [50(k)s]: Guidance for Industry and Food and Drug Administration Staff.)

Condition or Disease	Intervention/Treatment	Phase
Pulse Oximetry	Device: SpO2 Sensor application & blood draw	N/A

Detailed Description

The purpose of this study is to collect blood samples from neonates under normal clinical conditions to ensure proper function (clinical performance) with the U-TruSignal device.

The study will include both the TruSignal AllFit Sensor and TruSignal Sensitive Sensor.

After providing consent, no preparation beyond the investigational site's standard of care is required before study procedures begin. At the start of the procedure, one to two sensors, upon the discretion of the investigator, shall be applied to the subject.

The duration of the subject's participation in the study is dependent upon the scheduled routine arterial blood draw and obtaining the maximum of 6 data pairs (3 data pairs per sensor). The Investigator or designated study staff will collect of SpO2 and pulse rate for each study subject. Laboratory results from arterial blood draw will be collected from the hospital's medical records. The description, severity, and device relatedness of any AE or SAE during the study will be recorded.

Study Design

• Study Type: Interventional
• Actual Enrollment: 117 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: U-TruSignal SpO2 Testing in Neonates
• Actual Study Start Date: Sep 14, 2017
• Actual Primary Completion Date: Nov 1, 2019
• Actual Study Completion Date: Nov 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Device: 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.

Outcome Measures

Primary Outcome Measures

1. Accuracy Root Mean Square (ARMS) Per Data Pair [30 minutes per data pair]

   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).

Secondary Outcome Measures

1. Continuous SpO2 Measurements During Data Collection Interval [30 minutes per data pair]

   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

Other Outcome Measures

1. Type and Number of AEs, SAEs, and Device Issues [30 minutes per data pair]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 29 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Parents or legally authorized representative (LAR) can understand and provide written informed consent; AND

2. Subjects are < 29 days old, and requiring arterial blood samples per the site's standard of care.

Exclusion Criteria:

1. Neonates with injuries, deformities or abnormalities may prevent proper application of the sensor;

2. Neonates with inadequate heart pump function affecting blood circulation caused by identified cardiac or cardiovascular conditions such as patent ductus arteriosus, persistent pulmonary hypertension, septal defects, or congenital heart disease;

3. Neonates with mean arterial blood pressure < 20mmHg;

4. Neonates with congenital diaphragmatic hernia; OR

5. Neonates under High frequency ventilation therapy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tampere University Hospital (TAYS)	Tampere		Finland	33520
2	NH Narayana Multispecialty Hospital, Unit of Narayana Health, Mazumdar Shaw Medical Center	Bangalore		India	560099

Sponsors and Collaborators

• GE Healthcare

Investigators

• Principal Investigator: Rajiv Agarwal, MD, NH Narayana Multispecialty Hospital, Unit of Narayana Health, Mazumdar Shaw Medical Center
• Principal Investigator: Outi Tammela, MD, Tampere University Hospital (TAYS)

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 1, 2019

More Information

Publications

None provided.

• Responsible Party: GE Healthcare
• ClinicalTrials.gov Identifier: NCT03383757
• Other Study ID Numbers: 123.04-2017-GES-0002
• First Posted: Dec 26, 2017
• Last Update Posted: Dec 4, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Study Results

Participant Flow

Arm/Group Title	SpO2 Sensor Application & Blood Draw
Arm/Group Description	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.
Period Title: Overall Study
STARTED	117
TruSignal AllFit Sensor Subjects	56
TruSignal Sensitive Sensor Subjects	59
TruSignal AllFit Sensor Data Pairs	52
TruSignal Sensitive Sensor Data Pairs	51
COMPLETED	78
NOT COMPLETED	39

Baseline Characteristics

Arm/Group Title	SpO2 Sensor Application & Blood Draw
Arm/Group Description	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.
Overall Participants	78
Age, Customized (days) [Mean (Standard Deviation) ]
Age	5.2 (4.34)
Sex: Female, Male (Count of Participants)
Female	36 46.2%
Male	42 53.8%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Accuracy Root Mean Square (ARMS) Per Data Pair
Description	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).
Time Frame	30 minutes per data pair

Outcome Measure Data

Analysis Population Description

Participants may have multiple data points with multiple sensors.

Arm/Group Title	SpO2 Sensor Application & Blood Draw
Arm/Group Description	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.
Measure Participants	78
TS-AF ARMS	2.57
TS-SE ARMS	2.57

2. Secondary Outcome

Title	Continuous SpO2 Measurements During Data Collection Interval
Description	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
Time Frame	30 minutes per data pair

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SpO2 Sensor Application & Blood Draw
Arm/Group Description	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.
Measure Participants	78
TS-AF <=1% of invalid data	38 48.7%
TS-AF >1% of invalid data	0 0%
TS-SE <=1% of invalid data	40 51.3%
TS-SE >1% of invalid data	0 0%

3. Other Pre-specified Outcome

Title	Type and Number of AEs, SAEs, and Device Issues
Description	Collect safety information, including type and number of AE s, SAEs, and device issues.
Time Frame	30 minutes per data pair

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SpO2 Sensor Application & Blood Draw
Arm/Group Description	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.
Measure Participants	78
TruSignal AllFit Sensor AE	0
TruSignal AllFit Sensor SAE	0
TruSignal AllFit Sensor Device Issues	0
TruSignal Sensitive Sensor AE	0
TruSignal Sensitive Sensor SAE	0
TruSignal Sensitive Sensor Device Issues	0

Adverse Events

Time Frame	1 hour.
Arm/Group Title	SpO2 Sensor Application & Blood Draw
Arm/Group Description	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.
All Cause Mortality
	SpO2 Sensor Application & Blood Draw
	Affected / at Risk (%)	# Events
Total	0/78 (0%)
Serious Adverse Events
	SpO2 Sensor Application & Blood Draw
	Affected / at Risk (%)	# Events
Total	0/78 (0%)
Other (Not Including Serious) Adverse Events
	SpO2 Sensor Application & Blood Draw
	Affected / at Risk (%)	# Events
Total	0/78 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.