U-TruSignal SpO2 Testing in Neonates
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|ClinicalTrials.gov Identifier: NCT03383757|
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : July 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pulse Oximetry||Device: SpO2 Sensor application & blood draw||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||U-TruSignal SpO2 Testing in Neonates|
|Actual Study Start Date :||September 14, 2017|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
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.
- Accuracy Root Mean Square (ARMS) per data pair [ Time Frame: 30 minutes per data pair ]Compare observations of SpO2 (measured by the test pulse oximeter system) and SaO2 values (measured by CO-Oximeter analysis of simultaneous drawn arterial blood)
- Collection of continuous SpO2 measurements during a defined period of SpO2 data collection from the test pulse oximeter system [ Time Frame: 30 minutes per data pair ]The gaps in the measurement of SpO2 values (invalid data) will be calculated during a period of continuous SpO2 data collection with the test pulse oximeter system
- Type and number of AEs, SAEs, and device issues [ Time Frame: 30 minutes per data pair ]Collect safety information, including type and number of AE s, SAEs, and device issues.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383757
|Contact: Cynthia Hines-Sabolemail@example.com|
|Tampere University Hospital (TAYS)||Recruiting|
|Tampere, Finland, 33520|
|Contact: Outi Tammela, MD +358-3-311-66334 firstname.lastname@example.org|
|NH Narayana Multispecialty Hospital, Unit of Narayana Health, Mazumdar Shaw Medical Center||Recruiting|
|Bangalore, India, 560099|
|Contact: Rajiv Agarwal, MD 91 80 7122 2360 email@example.com|
|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)|