Performance of Pulse Oximeter Sensors 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

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-01

Study Completion Date

2019-05-10

Brief Summary

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

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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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Cardiac Surgery

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Test Subject

neonatal patients undergoing complex cardiac surgical procedures

Pulse Oximeter

Intervention Type DEVICE

Aulisa's non-invasive pulse oximeter sensor is applied to a foot of the neonate; an adhesive patch secures the sensor to the neonate.

Interventions

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Pulse Oximeter

Aulisa's non-invasive pulse oximeter sensor is applied to a foot of the neonate; an adhesive patch secures the sensor to the neonate.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Neonates scheduled to undergo cardiac surgery where routine blood draws would be taken
* 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

Minimum Eligible Age

0 Days

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No