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臨床試験

The BRAVE (Behaviourally Responsive Assessments of Vital Signs in Emergency) Study

NCT: NCT07828964 · NOT_YET_RECRUITING

NCT識別子NCT07828964
ステータスNOT_YET_RECRUITING
開始日2026-09-01
完了2028-08-31
SponsorHamilton Health Sciences Corporation (OTHER)
First posted
Last updated

概要

This is a randomized, unblinded, single-centre, pilot feasibility study. A total of 100 patients will be enrolled and randomized to have their vital signs collected using either the Masimo Radius PPG and Radius T in combination with standard equipment, or only the standard equipment. Within the experimental group, Children will have their HR, RR, SpO2, and T measured using the wearable monitors, specifically the Masimo Radius PPG and Radius T devices that are attached to them wirelessly. Blood pressure (BP) will then be measured using standard equipment in the ED, after obtaining wireless vital signs. For the control group, Children will have their vital signs measured using standard hospital vital sign monitoring equipment. The project will be deemed successful if all primary feasibility thresholds are met and preliminary data show a trend toward reduced time-to-vitals and distress without safety concerns. Additional indicators include clear identification of logistical/training needs, dissemination of findings (peer-reviewed publication, PERC/TREKK networks), and a refined protocol for a definitive trial. Achieving these will demonstrate both proof-of-concept and readiness for multi-centre implementation.

公式ソース

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