Comparison of Two Pulse Oximeters in Delivery Room

Shaare Zedek Medical Center

Status: Unknown

Conditions: Hypoxia

Treatments: Device: Nellcor; Device: Masimo

Study type: Interventional

Funder types: Other

Identifiers

NCT02704585

118/15

Details and patient eligibility

About

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

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 1 to 15 minutes old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Nellcor

Other group

Description:

Connection to Nellcor pulse oximeter for measuring oxygen saturation after birth

Treatment:

Device: Nellcor

Masimo

Other group

Description:

Connection to Masimo pulse oximeter for measuring oxygen saturation after birth

Treatment:

Device: Masimo