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Comparison of Two Pulse Oximeters in Delivery Room

Not Applicable
Conditions
Hypoxia
Interventions
Device: Nellcor
Device: Masimo
Registration Number
NCT02704585
Lead Sponsor
Shaare Zedek Medical Center
Brief Summary

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

Detailed 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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
100
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
NellcorNellcorConnection to Nellcor pulse oximeter for measuring oxygen saturation after birth
MasimoMasimoConnection to Masimo pulse oximeter for measuring oxygen saturation after birth
Primary Outcome Measures
NameTimeMethod
Time to steady reading in the pulse oximeterup to 2 minutes
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Ruben Bromiker

🇮🇱

Jerusalem, Israel

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