Pulse Oximeter Responses to Multiple Levels of Stable Hypoxia in Neonates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypoxia

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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SterilMed, Inc.

Principal Investigators

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Greg Stratmann, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Other Identifiers

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STER01P

Identifier Type: -

Identifier Source: org_study_id