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OpenTrials
Completed

NCT Number: NCT00751439

Verification of Pulse Oximetry in Neonatal Population

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.

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Key information

Age range

1 day–30 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, 55404, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Children's Hospitals and Clinics of Minnesota

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 12, 2008
Registry last updated
Jun 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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