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Non-Invasive Blood Pressure Monitor Accuracy in Neonatal Subjects

NCT02642198 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2016-03-23

No results posted yet for this study

Summary

This study is being conducted to validate the accuracy of non-invasive blood pressure (NIBP) measurement technology from Mortara Instrument, Inc. (Milwaukee, Wisconsin, USA) and Zoe Medical, Inc. (Topsfield, Massachusetts, USA) in a neonatal, infants and children up to 3 years old patient population. The study is defined according to the International Standard "ANSI/AAMI/ISO 81060-2:2013, Non-invasive sphygmomanometers - Part 2: Clinical investigation of automated measurement type".

Conditions

  • Non-invasive Blood Pressure

Interventions

DEVICE

Surveyor S12 and S19 patient monitor

Non-invasive blood pressure measurement

Sponsors & Collaborators

  • Mortara Instrument

    lead INDUSTRY

Eligibility

Min Age
29 Days
Max Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02642198 on ClinicalTrials.gov