NCT05673408招募中不适用
Non-Invasive Blood Pressure Validation Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 189
- 试验地点
- 10
- 主要终点
- Philips NIBP System Equivalence to Radial Arterial Line
研究概览
简要总结
The purpose of this study is to compare measurements of blood pressure (BP) between the Philips non-invasive blood pressure (NIBP) system (including NIBP cuff and portable patient monitor) and invasive radial for Subject Group 2 and 3, and radial or umbilical arterial line for neonates (A-line) in critical care patients.
详细描述
A multi-center, multi-phase, prospective, self-controlled, observational study.
- Phase I - A pilot phase designed for feasibility and the potential for algorithm development (enhancement).
- Phase II - Pivotal Phase: At the completion of Phase I -and finalization of the algorithm (if applicable), Phase II is designed for the purpose of establishing equivalence of the Philips NIBP system with the gold standard radial or umbilical (neonates) arterial line.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient admitted into the NICU, PICU, ICU, or OR (operating room)
- •Adult aged 18 years and older, or parent/legal guardian of minor, willing and able to understand and provide informed consent/assent
- •Indication for NIBP cuff
- •Indication for radial arterial line for Subject Group 2 and Subject Group 3, and radial or umbilical arterial line for Subject Group 1
- •Meet the following stratification criteria across the study:
- •Stratification (per the ISO 81060-2:2018/Amd-2:2024):
- •Subject Group 1:
- •At least 3 patients shall be <1000 g in weight
- •At least 3 patients shall be 1000 to 2000 g in weight
- •At least 3 patients shall be > 2000 g in weight
- •At least 3 patients shall be ≥ 29 days and < 1 year of age
- •At least 3 patients shall be ≥ 1 year and < 3 years of age
- •The remaining patients may be from any of the above age or weight groups in order to complete the sample size
- •A patient can be in more than one category simultaneously
- •Subject Group 2:
- •At least 30% male, 30% female
- •Limb circumference distributed as specified in ISO81060-2:2018/Amd2:
- •Subject Group 3:
- •At least 30% male, 30% female
- •Limb circumference distributed as specified in ISO81060- 2:2018/Amd-2:
- •At least 10% SBP ≤ 100mmHg
- •At least 10% SBP ≥ 160mmHg
- •At least 10% DBP ≤ 70mmHg
- •At least 10% DBP ≥ 85mmHg
排除标准
- •Inability to place the study device appropriately due to patient's anatomy or condition
- •Known pregnancy or lactating women (self-report)
- •Patients treated with an intra-aortic balloon pump
- •Aortic and mitral regurgitation (> 2 nd degree)
- •Measurements taken in the lateral position
- •Currently participating in another clinical trial with any product, treatment and/or medication that clinically interferes with the study endpoint(s)
- •If valid SBP reference measurements for lateral difference is > 15 mmHg (except for neonates with umbilical A-line)
- •If valid DBP reference measurements for lateral difference is > 10 mmHg (except for neonates with umbilical A-line)
- •At the Principal Investigator's discretion, subject does not qualify to participate in the study for any reasons that are not mentioned above
结局指标
主要结局
Philips NIBP System Equivalence to Radial Arterial Line
时间窗: Through study completion, approximately 1 year
The primary endpoint is the accuracy and precision of systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) measured by the Philips NIBP system (including NIBP cuff and portable patient monitor) in comparison to radial arterial line.
次要结局
未报告次要终点
研究者
研究点 (10)
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