U-TruSignal SpO2 Testing in Neonates

NCT ID: NCT03383757

Last Updated: 2020-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-14
• Study Completion Date: 2019-11-01

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.)

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

SpO2 Sensor application & blood draw

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Maximum Eligible Age: 29 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rajiv Agarwal, MD

Role: PRINCIPAL_INVESTIGATOR

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

Outi Tammela, MD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital (TAYS)

Locations

Tampere University Hospital (TAYS)

Tampere, , Finland

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

Bangalore, , India

Countries

Finland; India

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

123.04-2017-GES-0002

Identifier Type: -

Identifier Source: org_study_id