Verification of Pulse Oximetry in Neonatal Population

NCT00751439 | Completed

• 1 other identifier: 0802-024
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Distress Syndrome

Keywords

Oximeter; Arterial blood gas; comparison

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates 25 weeks gestation to full term

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospitals and Clinics of Minnesota: lead

Study Sites (1)

Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Mark C Mammel, M.D.

  Children's Hospitals & Clinics of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 11, 2008
• First Posted: September 12, 2008
• Study Start: June 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: September 1, 2009
• Last Updated: June 11, 2010

Record last verified: 2010-06

Locations

US (1)