Pulse OximetryNCT03383757
U-TruSignal SpO2 Testing in Neonates
A study testing SpO2 Sensor application & blood draw in people with Pulse Oximetry, run by GE Healthcare at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 29 days
- Conditions the study is for
- Pulse Oximetry
- What is being tested?
- SpO2 Sensor application & blood draw
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 14 Sep 2017to 1 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 29 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parents or legally authorized representative (LAR) can understand and provide written informed consent; AND
- Subjects are < 29 days old, and requiring arterial blood samples per the site's standard of care.
Who cannot join
- Neonates with injuries, deformities or abnormalities may prevent proper application of the sensor;
- 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;
- Neonates with mean arterial blood pressure < 20mmHg;
- Neonates with congenital diaphragmatic hernia; OR
- Neonates under High frequency ventilation therapy.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
India1 site
NH Narayana Multispecialty Hospital, Unit of Narayana Health, Mazumdar Shaw Medical Center
Bangalore, 560099
About this study
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.)
Read the 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.
- Conditions
- Pulse Oximetry
- Being tested
- SpO2 Sensor application & blood draw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpO2 Sensor application & blood drawDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| SpO2 Sensor Application & Blood draw | Experimental | 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 Receives: Device: SpO2 Sensor application & blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy Root Mean Square (ARMS) 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).
Measured: 30 minutes per data pair
Secondary outcomes (1)
Continuous SpO2 Measurements During Data Collection Interval
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
Measured: 30 minutes per data pair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start14 Sep 2017
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulse OximetryStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rajiv Agarwal, MD, Principal investigator, NH Narayana Multispecialty Hospital, Unit of Narayana Health, Mazumdar Shaw Medical CenterOuti Tammela, MD, Principal investigator, Tampere University Hospital (TAYS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383757
- Sponsor's protocol ID
- 123.04-2017-GES-0002
- Status last verified
- Dec 2020
- First submitted
- 3 Nov 2017
- Last updated
- 4 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- U-TruSignal SpO2 Testing in Neonates
- ClinicalTrials.gov ID
- NCT03383757
- Acronym / sponsor ID
- 123.04-2017-GES-0002
- Conditions
- Pulse Oximetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 26 Dec 2017 (actual)
- Results
- Posted 4 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.)
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SpO2 Sensor Application & Blood draw | Experimental | Device: SpO2 Sensor application & blood drawAll 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 |
Who may qualify
- Ages
- Up to 29 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Parents or legally authorized representative (LAR) can understand and provide written informed consent; AND
- Subjects are < 29 days old, and requiring arterial blood samples per the site's standard of care.
Key exclusion criteria (5 listed)
- Neonates with injuries, deformities or abnormalities may prevent proper application of the sensor;
- 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;
- Neonates with mean arterial blood pressure < 20mmHg;
- Neonates with congenital diaphragmatic hernia; OR
- Neonates under High frequency ventilation therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpO2 Sensor application & blood drawAt 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. | Device | SpO2 Sensor Application & Blood draw |
Primary outcome
Accuracy Root Mean Square (ARMS) Per Data Pair
Time frame: 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).
1 secondary outcome
Continuous SpO2 Measurements During Data Collection Interval
Time frame: 30 minutes per data pair
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Pulse Oximetry
Not yet recruiting
Local Warming to Improve Pulse Oximetry Accuracy in Critically Ill Patients
Critical Illness, Low Peripheral Perfusion
Active, not recruiting
Neonatal Pulse Oximetry Disparities Due to Skin Pigmentation
Skin Pigment, Pulse Oximetry
RecruitingObservational study
The Impact of Skin Tone on Pulse Oximeter Accuracy
Accuracy of Pulse Oximetry Across Skin Pigmentation Levels
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajiv Agarwal, MD principal investigator
NH Narayana Multispecialty Hospital, Unit of Narayana Health, Mazumdar Shaw Medical Center
Outi Tammela, MD principal investigator
Tampere University Hospital (TAYS)
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SpO2 Sensor application & blood draw in people with Pulse Oximetry, run by GE Healthcare at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy Root Mean Square (ARMS) Per Data Pair (time frame: 30 minutes per data pair). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2020; AzTrials last refreshed its copy on 26 Oct 2026.