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NCT02704585 Clinical Trial

Comparison of Two Pulse Oximeters in Delivery Room

Hypoxia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02704585
Other study ID # 118/15
Secondary ID
Status Recruiting
Phase N/A
First received February 24, 2016
Last updated March 9, 2016
Start date January 2016
Est. completion date January 2017

Study information
Verified date March 2016
Source Shaare Zedek Medical Center
Contact Yakir Shir, MD
Phone 972523121040
Email yakirshir@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

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

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 information / eligibility
Status Recruiting
Enrollment 100
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 15 Minutes
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• Nellcor
Measurement of pulse oximetry in the delivery room with Nellcor pulse oximeter
• Masimo
Measurement of pulse oximetry in the delivery room with Masimo pulse oximeter

Locations
Country Name City State
Israel Ruben Bromiker Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Baquero H, Alviz R, Castillo A, Neira F, Sola A. Avoiding hyperoxemia during neonatal resuscitation: time to response of different SpO2 monitors. Acta Paediatr. 2011 Apr;100(4):515-8. doi: 10.1111/j.1651-2227.2010.02097.x. Epub 2011 Jan 17. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Time to steady reading in the pulse oximeter up to 2 minutes No
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