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Verification of Pulse Oximetry in Neonatal Population

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00751439
First Posted: September 12, 2008
Last Update Posted: June 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Children's Hospitals and Clinics of Minnesota
September 11, 2008
September 12, 2008
June 11, 2010
June 2008
June 2009   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00751439 on ClinicalTrials.gov Archive Site
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Verification of Pulse Oximetry in Neonatal Population
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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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample
Neonates 25 weeks gestation to full term
Respiratory Distress Syndrome
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
September 2009
June 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 30 Days   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00751439
0802-024
No
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Mark Mammel, M.D., Children's Hospitals & Clinics of Minnesota
Children's Hospitals and Clinics of Minnesota
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Principal Investigator: Mark C Mammel, M.D. Children's Hospitals & Clinics of Minnesota
Children's Hospitals and Clinics of Minnesota
June 2010