Recruiting
Observational
Philips Inflationary-Based Non-Invasive Blood Pressure Validation Study
Condition(s) studied
Blood Pressure Measurement
Investigational drug(s) / intervention(s)
Blood Pressure Measurement
Blood Pressure Measurement: The Philips inflationary based algorithm of the IntelliVue X3 Monitor will be used to measure systolic blood pressure, diastolic blood pressure, and mean arterial pressure compared to the ausculatory reference method.
Study summary
The main purpose of this study is to assess the equivalence between blood pressure measurements obtained using the Philips iNIBP system and those determined by the auscultatory reference method.
Eligibility
Inclusion Criteria:
* Participants must be 3 to 85 years of age.
* Participants, parents or legal guardians of participants must be able to provide informed consent, parental permission, and/or assent form.
* Participants that are between 7 and 17 (inclusive) years of age must provide assent to participate in the study.
* Participants, parents or legal guardians of participants must be able to read or write in English and participants that are between the age of 7-17 must be able to understand English to provide assent.
* Participant must be willing and able to comply with study procedures and duration.
* Participants must have an upper arm circumference in the range of 14-43 centimeters.
Exclusion Criteria:
* Participant, parent or legal guardian of participant is unwilling to provide informed consent, parental permission, and/or assent.
* Participants with deformities or abnormalities that may prevent proper application of the device under test.
* Participants with an upper arm circumference less than 14 cm or greater than 43 cm.
* Female participants who are pregnant.
* Female participants who are trying to get pregnant with confirmation of positive urine pregnancy test.
* Participants with known heart arrhythmias.
* Participants with peripheral vascular disease.
* Participants with clotting disorders.
* History of bleeding disorders or personal history of prolonged bleeding from injury.
* History of blood clots.
* Hemophilia.
* Participants that cannot tolerate sitting for up to 1-2 hours.
* Participant with a blood pressure or other demographics that have already been filled.
* Other known health conditions that will prevent safe participation in the study upon disclosure in screening form or verbally.
* Participant is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study.
* Participants where the Korotkoff sounds (fifth phase (K5)) for determining DBP is not audible.
Primary outcome measure(s)
- Compare blood measurements obtained from the Philips Inflationary-based non-invasive blood pressure (iNIBP) system to the accepted auscultatory reference method. — Up to 8 weeks
Compare blood measurements (systolic blood pressure, diastolic blood pressure, and mean arterial pressure) obtained from the Philips Inflationary-based non-invasive blood pressure (iNIBP) system to the accepted auscultatory reference method.
Trial sites (1)
| Facility | City | Region | Status |
| Element Materials Technology |
Louisville |
Colorado |
Recruiting |
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