Comparison of Two Pulse Oximeters in Delivery Room

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-01-31

Brief Summary

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Time to stable reading of oxygen saturation at the delivery room will be compared between two different devices.

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Detailed Description

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After delivery babies will be located in the radiant warmer. The probe of each pulse oximeter will be applied to one of the feet. Both probes will be simultaneously connected to the female plug of the pulse oximeter.

Heart rate will be checked

Time to get a stable reading in each device (by observation on the devices' display) will be recorded; this will be the primary study outcome. Other vital signs (oxygen saturation, heart rate) and demographics) will be recorded as well.

Paired students T test will be used for the statistical analyzes.

Conditions

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Hypoxia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Nellcor

Connection to Nellcor pulse oximeter for measuring oxygen saturation after birth

Group Type OTHER

Nellcor

Intervention Type DEVICE

Measurement of pulse oximetry in the delivery room with Nellcor pulse oximeter

Masimo

Connection to Masimo pulse oximeter for measuring oxygen saturation after birth

Group Type OTHER

Masimo

Intervention Type DEVICE

Measurement of pulse oximetry in the delivery room with Masimo pulse oximeter

Interventions

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Nellcor

Measurement of pulse oximetry in the delivery room with Nellcor pulse oximeter

Intervention Type DEVICE

Masimo

Measurement of pulse oximetry in the delivery room with Masimo pulse oximeter

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Neonates in the operation or delivery room immediately after delivery whose parents agreed to enter the study

Exclusion Criteria

* Malformation of one of the legs, not allowing sensor application. Any situation in which the study might interfere with the treatment of the newborn

Minimum Eligible Age

1 Minute

Maximum Eligible Age

15 Minutes

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes