Validation of the A&D UA-651 Oscillometric Blood Pressure Monitor in Children
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Blood Pressure Triplet
研究概览
简要总结
This study will determine if the A&D UA-651 blood pressure monitor is valid in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
盲法说明
Investigators and assessors will need to know which device is associated with each measurement to perform analysis as specified in ISO/ESH/AAMI standards, but observers taking manual reference blood pressure measurements will be blinded as to each other's measurements.
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent permission
- •Assent for participants aged 7-12
- •Additional sequential selection criteria (described below)
排除标准
- •Withdrawal of permission or assent
- •Younger than 3 or older than 12 years of age
- •Uncooperative participants, defined as refusing instructions from study personnel, coordinators, or observers
- •Physical preclusion to taking blood pressure
- •Participants who have any reference blood pressure measurement exceeding the 95th percentile plus 30mmHg for their age, sex, and height (urgent blood pressure level as defined by the American Academy of Pediatrics)
- •Participants with systolic blood pressure difference of greater than 12mmHg or diastolic blood pressure difference of greater than 8mmHg between any two reference measurements
- •Sequential Selection Criteria:
- •Participants will be selected sequentially during study events. Per ISO/ESH/AAMI standards, participants must meet the following characteristics:
- •at least 30% male and 30% female
- •at least 1/6 using each of the three available cuff sizes (small, medium, large)
- •for each cuff size, at least 40% in the upper half of the arm circumference range and at least 40% in the lower half of the arm circumference range.
- •If including a participant would require that additional participants be enrolled to meet the above criteria, that participant will not be included. For example, if only 2 small cuff participants are needed to complete the study, but a prospective participant would require a large cuff AND including that participant will require additional small or medium cuff participants to complete the study, then that prospective participant will not be included.
研究组 & 干预措施
Small Cuff
Participants with an upper-arm circumference of 6.3-9.4" may be placed in the small cuff arm.
干预措施: A&D UA-651 Blood Pressure Monitor (Device)
Small Cuff
Participants with an upper-arm circumference of 6.3-9.4" may be placed in the small cuff arm.
干预措施: ADC 740-N Manual Sphygmomanometer (Device)
Medium Cuff
Participants with an upper-arm circumference of 9.0-14.6" may be placed in the medium cuff arm.
干预措施: A&D UA-651 Blood Pressure Monitor (Device)
Medium Cuff
Participants with an upper-arm circumference of 9.0-14.6" may be placed in the medium cuff arm.
干预措施: ADC 740-N Manual Sphygmomanometer (Device)
Lage Cuff
Participants with an upper-arm circumference of 12.2-17.7" may be placed in the large cuff arm.
The large cuff arm will use an adaptive study design. Per the AAMI/ESH/ISO standards, at least 1/6 of participants must fall into each cuff size arm for that cuff size, and of the participants assigned to each cuff size, at least 40% of those must fall in the upper and lower half of the cuff's size range. However, we do not anticipate many participants in our age range falling in the upper half of the large cuff size range (upper arm circumference > 14.95").
Because of this, our plan is to validate the large cuff, but if enrolling a patient with a large cuff would require additional patients be enrolled to reach 1/6 of the total sample, the large cuff will be dropped from consideration and the validation completed with only the small and medium cuffs.
干预措施: A&D UA-651 Blood Pressure Monitor (Device)
Lage Cuff
Participants with an upper-arm circumference of 12.2-17.7" may be placed in the large cuff arm.
The large cuff arm will use an adaptive study design. Per the AAMI/ESH/ISO standards, at least 1/6 of participants must fall into each cuff size arm for that cuff size, and of the participants assigned to each cuff size, at least 40% of those must fall in the upper and lower half of the cuff's size range. However, we do not anticipate many participants in our age range falling in the upper half of the large cuff size range (upper arm circumference > 14.95").
Because of this, our plan is to validate the large cuff, but if enrolling a patient with a large cuff would require additional patients be enrolled to reach 1/6 of the total sample, the large cuff will be dropped from consideration and the validation completed with only the small and medium cuffs.
干预措施: ADC 740-N Manual Sphygmomanometer (Device)
结局指标
主要结局
Blood Pressure Triplet
时间窗: Immediate
A valid set of 3 measurements (reference-test-reference) will be considered one outcome measurement for validation.
次要结局
未报告次要终点