Medtronic_MDT24005PROLD

What is the Purpose of this Study?

Primary: - compare time to accurate stable signal and overall accuracy of HR estimation between two pulse oximeters as compared to gold standard ECG. Secondary: - To evaluate instances of false bradycardia defined as PR < 100 beats per minute (BPM) for a duration of 30 seconds or greater when HRECG is >100. - To evaluate instances of false bradycardia requiring emergency medical treatment defined as PR < 60 BPM for a duration of 30 seconds or greater when HRECG is > 60. - To evaluate variability in PR between the two pulse-oximeters. - To compare the number of repositions and replacements required for the two PO sensors during monitoring.


Eligibility

  • * Parent or legal guardian is willing and able to provide informed consent prior to any study procedures being performed.
  • * Subject is expected to be able to participate for the duration of the evaluation in the delivery room. In most instances, the length of the study will not exceed the anticipated duration of ECG monitoring.
  • * Subject is ≥ 29 weeks gestational age.
  • * Subject can accommodate multiple sensors.
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

Nellcor vs Masimo Pulse Oximetry Performance Comparison in Newborns

Study Details
Disease Type/Condition

Other

Principal Investigator

Biniwale, Manoj

Age Group

Children

Phase

N/A

IRB Number

STUDY00003715

ClinicalTrials.gov ID

NCT06637917

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Biniwale, Manoj

Age Group

Children

Phase

N/A

IRB Number

MDT24005PROLD

ClinicalTrials.gov ID

NCT06637917

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org