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Comparison of Two Pulse Oximeters in Delivery Room

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02704585
Enrollment
100
Registered
2016-03-10
Start date
2016-01-31
Completion date
2017-01-31
Last updated
2016-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxia

Keywords

Neonatal resuscitation, Pulse oximetry

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.

Interventions

DEVICENellcor

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

DEVICEMasimo

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

Sponsors

Shaare Zedek Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Minutes to 15 Minutes
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Time to steady reading in the pulse oximeterup to 2 minutes

Countries

Israel

Contacts

Primary ContactYakir Shir, MD
yakirshir@gmail.com972523121040

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026