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Trial record 86 of 415 for:    shaare zedek

Comparison of Two Pulse Oximeters in Delivery Room

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ClinicalTrials.gov Identifier: NCT02704585
Recruitment Status : Unknown
Verified March 2016 by Bromiker, Ruben M.D, Shaare Zedek Medical Center.
Recruitment status was:  Recruiting
First Posted : March 10, 2016
Last Update Posted : March 10, 2016
Sponsor:
Information provided by (Responsible Party):
Bromiker, Ruben M.D, Shaare Zedek Medical Center

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

Condition or disease Intervention/treatment Phase
Hypoxia Device: Nellcor Device: Masimo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Two Pulse Oximeters in Delivery Room: A Prospective Study
Study Start Date : January 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Arm Intervention/treatment
Nellcor
Connection to Nellcor pulse oximeter for measuring oxygen saturation after birth
Device: Nellcor
Measurement of pulse oximetry in the delivery room with Nellcor pulse oximeter

Masimo
Connection to Masimo pulse oximeter for measuring oxygen saturation after birth
Device: Masimo
Measurement of pulse oximetry in the delivery room with Masimo pulse oximeter




Primary Outcome Measures :
  1. Time to steady reading in the pulse oximeter [ Time Frame: up to 2 minutes ]


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Ages Eligible for Study:   up to 15 Minutes   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02704585


Contacts
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Contact: Yakir Shir, MD 972523121040 yakirshir@gmail.com

Locations
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Israel
Ruben Bromiker Recruiting
Jerusalem, Israel, 91031
Contact: Ruben Bromiker, MD    972508685154    bromi@smc.org.il   
Contact: Yakir Shir, MD    972523121040    yakirshir@gmail.com   
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
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Study Chair: Ruben Bromiker, MD Shaare Zedek Medical Center

Publications of Results:
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Responsible Party: Bromiker, Ruben M.D, Senior Neonatologist, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02704585     History of Changes
Other Study ID Numbers: 118/15
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: March 10, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Bromiker, Ruben M.D, Shaare Zedek Medical Center:
Neonatal resuscitation
Pulse oximetry

Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms