Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia in Neonates

Hypoxia Clinical Trial

Official title:

Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia in Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01253772
• Other study ID #: STER01P
• Status: Completed
• Phase: N/A
• First received: December 1, 2010
• Last updated: December 2, 2010
• Start date: May 2010
• Est. completion date: August 2010

Study information

• Verified date: December 2010
• Source: SterilMed, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Description:

Researchers at the University of California, San Francisco have developed methods that permit them to test multiple pulse oximeter sensors on neonates simultaneously during cardiac surgery. During this type of surgery, the arterial oxygen saturation changes over a wide range, providing an ideal arena for the assessment of neonatal pulse oximeter sensors at many levels of oxygen saturation. Several arterial blood gas samples are typically obtained during these procedures. Saturation of each arterial blood sample is determined by direct oximetry in a hemoximeter and this measurement is compared to the reading displayed on the pulse oximeter.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• Neonatal patient scheduled to undergo cardiac surgery where routine blood draws would be taken

• Understand and provide signed parental/guardian consent

Exclusion Criteria:

• Failure to obtain parental consent

• Patients shown to have an adverse reaction to medical tape/adhesive

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypoxia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SterilMed, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SpO2 Accuracy Verification Study (ARMS) of = 3%		During Analysis - data were collected anywhere from the beginning of surgery until the completion of the procedure	No