NCT06682312

Philips Non-Invasive Blood Pressure Validation Study

Element Boulder Clinical Investigation Plan Philips Non-Invasive Blood Pressure Validation Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 89 (actual)
• Sponsor: Philips Clinical & Medical Affairs Global · Industry
• Sex: All
• Age: 3 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to provide supporting documentation of the blood pressure performance for the Philips EarlyVue VS30 monitor on the intended adult and pediatric population. The same arm sequential method with dual observer auscultation will be used to collect data.

Detailed description

The Philips EarlyVue VS30 monitor, and approved Philips Gentle Care cuffs will be evaluated in comparison to dual reference auscultation. The study will consist of a minimum of 85 participants, specifically, 35 children aged 3-12 years and 50 participants older than 12 years. The participants enrolled will approximate the distribution of blood pressures and biceps circumferences as outlined in ISO 81060-2:2018/AMD 2:2024. The maximum number of participants enrolled will not exceed 170 participants. Blood pressure measurements will follow ISO 81060-2:2018/AMD 2:2024, Section 5.2.4.1 Same arm sequential method. Two trained observers, typically a Registered Nurse (RN), Licensed Practical Nurse (LPN), or Respiratory Therapist (RT) will observe (listen to) the Korotkoff sounds at the artery at the site of cuff placement. The reference blood pressure measurements observed by the auscultators will be performed sequentially with the device under test. The auscultators will complete 1 or 2 initial baseline auscultatory reference blood pressure measurements and device under test measurements. This is followed by 3 to 8 paired blood pressure readings of auscultatory reference blood pressure measurements alternated with device under test measurements. All participants must contribute 3 valid paired data points requiring three DUT readings paired with three reference blood pressure readings. The reference blood pressure readings for analysis will be the average of the reference dual auscultation values before and after DUT reading. The data included for the final analysis will contain no fewer than 35 participants aged 3-12 years, and no fewer than 50 participants over the age of 12 and a minimum of 255 valid paired observations.

Conditions

• Non Invasive Blood Pressure

Interventions

Type	Name	Description
DEVICE	Non-invasive blood pressure	Manual blood pressure via sphygmomanometer Or Non invasive blood pressure via earlyvue VS30 Monitor

Timeline

• Start date: 2024-10-14
• Primary completion: 2024-10-23
• Completion: 2024-10-23
• First posted: 2024-11-12
• Last updated: 2024-11-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study