NCT03383757

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.)

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 14, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 26, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 4, 2020

Completed
Last Updated

December 4, 2020

Status Verified

December 1, 2020

Enrollment Period

2.1 years

First QC Date

November 3, 2017

Results QC Date

May 18, 2020

Last Update Submit

December 3, 2020

Conditions

Pulse Oximetry

Outcome Measures

Primary Outcomes (1)

  • 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).

    30 minutes per data pair

Secondary Outcomes (1)

  • Continuous SpO2 Measurements During Data Collection Interval

    30 minutes per data pair

Other Outcomes (1)

  • Type and Number of AEs, SAEs, and Device Issues

    30 minutes per data pair

Study Arms (1)

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

Device: SpO2 Sensor application & blood draw

Interventions

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.

SpO2 Sensor Application & Blood draw

Eligibility Criteria

AgeUp to 29 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tampere University Hospital (TAYS)

Tampere, 33520, Finland

Location

NH Narayana Multispecialty Hospital, Unit of Narayana Health, Mazumdar Shaw Medical Center

Bangalore, 560099, India

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Results Point of Contact

Title
Clinical Affairs Project Manager
Organization
GE Healthcare
stephanie.karwedsky@ge.com
262-443-7008

Study Officials

  • Rajiv Agarwal, MD

    NH Narayana Multispecialty Hospital, Unit of Narayana Health, Mazumdar Shaw Medical Center

    PRINCIPAL INVESTIGATOR

  • Outi Tammela, MD

    Tampere University Hospital (TAYS)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2017

First Posted

December 26, 2017

Study Start

September 14, 2017

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

December 4, 2020

Results First Posted

December 4, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)IN(1)