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Clinical Trials/NCT02704585
NCT02704585
Unknown
Not Applicable

Comparison of Two Pulse Oximeters in Delivery Room: A Prospective Study

Shaare Zedek Medical Center1 site in 1 country100 target enrollmentJanuary 2016
ConditionsHypoxia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypoxia
Sponsor
Shaare Zedek Medical Center
Enrollment
100
Locations
1
Primary Endpoint
Time to steady reading in the pulse oximeter
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
January 2017
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bromiker, Ruben M.D

Senior Neonatologist

Shaare Zedek Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Time to steady reading in the pulse oximeter

Time Frame: up to 2 minutes

Study Sites (1)

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