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Verification of Pulse Oximetry in Neonatal Population

This study has been completed.
Sponsor:
Information provided by:
Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier:
NCT00751439
First received: September 11, 2008
Last updated: June 10, 2010
Last verified: June 2010
History of Changes
  Purpose

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.


Condition
Respiratory Distress Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Verification of Pulse Oximetry in Neonatal Population

Further study details as provided by Children's Hospitals and Clinics of Minnesota:

Estimated Enrollment: 25
Study Start Date: June 2008
Study Completion Date: September 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 30 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Neonates 25 weeks gestation to full term

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00751439

Locations
United States, Minnesota
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Children's Hospitals and Clinics of Minnesota
Investigators
Principal Investigator: Mark C Mammel, M.D. Children's Hospitals & Clinics of Minnesota
  More Information

No publications provided

Responsible Party: Mark Mammel, M.D., Children's Hospitals & Clinics of Minnesota
ClinicalTrials.gov Identifier: NCT00751439     History of Changes
Other Study ID Numbers: 0802-024
Study First Received: September 11, 2008
Last Updated: June 10, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospitals and Clinics of Minnesota:
Oximeter
Arterial blood gas
comparison

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
 Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on June 18, 2013