Verification of Pulse Oximetry in Neonatal Population

Completed

• Conditions: Respiratory Distress Syndrome

• Registration Number: NCT00751439
• Lead Sponsor: Children's Hospitals and Clinics of Minnesota

Brief Summary

The purpose of this his post-market, observational study titled Verification of Pulse Oximetry in the Neonatal Population is to gather data to further support the accuracy of Nonin's pulse oximeters when used in the neonate population. Neonates who are currently undergoing arterial blood gas (ABG) sampling, as part of their medical care will be recruited to participate in this study for collecting opportunity samples. Nonin's PureLight® noninvasive sensor will be applied to a foot of the neonate; an adhesive wrap secures the sensor to the neonate. The sensor immediately begins obtaining SpO2 and pulse rate measurements which are sent to the oximeter module for display on the Electronic Data Collection System (EDCS). At the time the prescribed ABG is drawn, the EDCS must have a marker captured to identify the end of the ABG for SpO2 comparison. The SpO2 accuracy of pulse oximeter will be measured by comparing SpO2 readings of the pulse oximeter to values of SaO2 (opportunity samples) determined by a CO-oximeter.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-09-11
• Study First Submitted QC: 2008-09-11
• Study First Posted: 2008-09-12
• Primary Completion: 2009-06
• Study Completion: 2009-09
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-10
• Last Update Posted: 2010-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Gestational age: 25 weeks to full term
• Weight range: No minimum or maximum range
• Age: up to 1 month (30 DAYS)
• Gender: Both
• ABGs as part of their medical care, to be analyzed by co-oximeter
• Consent signed by at least one legal guardian

Exclusion Criteria

• Presence of any skin irritation or breakdown on the foot
• Foot impediments which would preclude proper placement of the sensor
• Clinical condition precluding the use of adhesive materials
• Cessation of ABGs during study enrollment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Children's Hospitals and Clinics of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States