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Comparison of Two Pulse Oximeters in Delivery Room

Primary Purpose

Hypoxia

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Nellcor
Masimo
Sponsored by
Shaare Zedek Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypoxia focused on measuring Neonatal resuscitation, Pulse oximetry

Eligibility Criteria

1 Minute - 15 Minutes (Child)All SexesAccepts 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

Sites / Locations

  • Ruben BromikerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Nellcor

Masimo

Arm Description

Connection to Nellcor pulse oximeter for measuring oxygen saturation after birth

Connection to Masimo pulse oximeter for measuring oxygen saturation after birth

Outcomes

Primary Outcome Measures

Time to steady reading in the pulse oximeter

Secondary Outcome Measures

Full Information

First Posted
February 24, 2016
Last Updated
March 9, 2016
Sponsor
Shaare Zedek Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02704585
Brief Title
Comparison of Two Pulse Oximeters in Delivery Room
Official Title
Comparison of Two Pulse Oximeters in Delivery Room: A Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shaare Zedek Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia
Keywords
Neonatal resuscitation, Pulse oximetry

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nellcor
Arm Type
Other
Arm Description
Connection to Nellcor pulse oximeter for measuring oxygen saturation after birth
Arm Title
Masimo
Arm Type
Other
Arm Description
Connection to Masimo pulse oximeter for measuring oxygen saturation after birth
Intervention Type
Device
Intervention Name(s)
Nellcor
Intervention Description
Measurement of pulse oximetry in the delivery room with Nellcor pulse oximeter
Intervention Type
Device
Intervention Name(s)
Masimo
Intervention Description
Measurement of pulse oximetry in the delivery room with Masimo pulse oximeter
Primary Outcome Measure Information:
Title
Time to steady reading in the pulse oximeter
Time Frame
up to 2 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
15 Minutes
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yakir Shir, MD
Phone
972523121040
Email
yakirshir@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruben Bromiker, MD
Organizational Affiliation
Shaare Zedek Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Ruben Bromiker
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruben Bromiker, MD
Phone
972508685154
Email
bromi@smc.org.il
First Name & Middle Initial & Last Name & Degree
Yakir Shir, MD
Phone
972523121040
Email
yakirshir@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21091987
Citation
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.
Results Reference
result

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Comparison of Two Pulse Oximeters in Delivery Room

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