Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia in Neonates

NCT01253772 | Completed

• 1 other identifier: STER01P
• Study Type: observational
• Target: 4
• Locations: 0 countries
• Sites: N/A

Brief Summary

Validate pulse oximeter sensors in neonates by comparing sensor readings to blood samples during cardiac surgery.

Conditions

Hypoxia

Outcome Measures

Primary Outcomes (1)

• SpO2 Accuracy Verification Study (ARMS) of ≤ 3%

  During Analysis - data were collected anywhere from the beginning of surgery until the completion of the procedure

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonatal children undergoing complex cardiac surgical procedures.

You may qualify if:

• Neonatal patient scheduled to undergo cardiac surgery where routine blood draws would be taken
• Understand and provide signed parental/guardian consent

You may not qualify if:

• Failure to obtain parental consent
• Patients shown to have an adverse reaction to medical tape/adhesive

Sponsors & Collaborators

• SterilMed, Inc.: lead

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Greg Stratmann, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 3, 2010
• Study Start: May 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: December 3, 2010

Record last verified: 2010-12