- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02704585
Comparison of Two Pulse Oximeters in Delivery Room
Comparison of Two Pulse Oximeters in Delivery Room: A Prospective Study
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yakir Shir, MD
- Phone Number: 972523121040
- Email: yakirshir@gmail.com
Study Locations
-
-
-
Jerusalem, Israel, 91031
- Recruiting
- Ruben Bromiker
-
Contact:
- Ruben Bromiker, MD
- Phone Number: 972508685154
- Email: bromi@smc.org.il
-
Contact:
- Yakir Shir, MD
- Phone Number: 972523121040
- Email: yakirshir@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Nellcor
Connection to Nellcor pulse oximeter for measuring oxygen saturation after birth
|
Measurement of pulse oximetry in the delivery room with Nellcor pulse oximeter
|
Other: Masimo
Connection to Masimo pulse oximeter for measuring oxygen saturation after birth
|
Measurement of pulse oximetry in the delivery room with Masimo pulse oximeter
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to steady reading in the pulse oximeter
Time Frame: up to 2 minutes
|
up to 2 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ruben Bromiker, MD, Shaare Zedek Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 118/15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypoxia
-
Western University, CanadaUnknownBrain Hypoxia IschemiaCanada
-
Yale UniversityTianjin Chest HospitalCompletedBrain Ischemia Hypoxia | Muscle; Ischemic | Muscle HypoxiaChina
-
Fliegerärztliches InstitutCompleted
-
University of Texas at AustinCompletedIntermittent HypoxiaUnited States
-
Owlet Baby Care, Inc.Completed
-
Robert L. OwensCompletedIntermittent HypoxiaUnited States
-
Montreal Heart InstituteUniversité de MontréalCompleted
-
United States Army Research Institute of Environmental...University of Puget SoundRecruiting
-
The University of Hong Kong-Shenzhen HospitalRecruiting
-
Sherief Abd-ElsalamRecruiting
Clinical Trials on Nellcor
-
University Hospital Inselspital, BerneCompletedLeft Ventricular Assist DeviceSwitzerland
-
Yale UniversityCompletedHypoxia | HypoventilationUnited States
-
Laval UniversityNot yet recruitingPneumonia | COPD Exacerbation | Respiratory Disease | Hypoxemia
-
Medtronic - MITGCompletedSleep Disordered BreathingUnited States
-
West China HospitalUnknownAcute Respiratory Distress SyndromeChina
-
McMaster UniversityHamilton Health Sciences CorporationCompletedRespiratory DepressionCanada
-
Medtronic - MITGCompletedPatients Prescribed Non-invasive Respiratory MonitoringUnited States
-
Medtronic - MITGCompletedHealthy VolunteersUnited States
-
OridionHerzog HospitalCompleted
-
Ramathibodi HospitalCompleted