Comparison of Noninvasive Oscillometric Blood Pressure with Invasive Arterial Blood Pressure in Critically Ill Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- To evaluate the agreement between blood pressure measurements obtained with non-invasive oscillometry (test method) and arterial catheter-derived measurements (reference method).
研究概览
简要总结
Referenceblood pressure will be measured invasively using an indwelling arterialcatheter placed in the radial artery or femoral artery.
Ø The arterial catheter transducerwill be zeroed (to atmosphere) and levelled (right atrium).
Ø Fast Flush test will be performed toconfirm optimal damping.With optimal damping, the measured pressureshould come to reflect the biological signal within one or two oscillations.
Ø If not optimally damped,troubleshooting will be done to achieve it. Patient will not be included in thestudy if optimal damping cannot be achieved.
Non-invasiveoscillometric blood pressure measurements will be performed using an upper-armcuff. (contralateral arm when the arterial line is radial).
Ø Arm circumference will be measuredat the midpoint of acromion & olecranon. The correct cuff size will beestimated for each patient. The “ideal†cuff should have a bladder length thatis 80% and a width that is at least 40% of arm circumference (a length-to-widthratio of 2:1)
Ø The cuff will be placed on bareskin.
Ø If there is an error in noninvasiveoscillometric measurement, that measurement is discarded and new measurementwill be taken after atleast 3 minutes.
Thereadings from the monitor (invasive arterial line BP & oscillometric BP)will be noted at the end of oscillometric BP measurement.
Each pairof measurements – invasive and oscillometric (Systolic, Diastolic & MeanArterial Pressures) – will be taken three times at intervals of three minutes.The average will be calculated and considered as the result of the measurement.
Multiplemeasurements (maximum of 3) may be recorded for each patient at random timeintervals(at least 6 hours apart).
The firstmeasurement will be taken within 48 hours of placement of arterial line.
All themeasurements will be taken within 7 days of inclusion in the study.
The dose ofvasopressor(s) infusion will be documented at the time of the blood pressuremeasurement.
Vasoactive-inotropicscore will be calculated for patients on vasopressor(s) &inotrope(s)
Once thesample collection is complete, patients will be categorized based on the medianVasoactive Inotrope Score (VIS) into the following categories for comparison ofblood pressure measurements
Ø No Vasopressors (VIS = 0)
Ø High dose vasopressors (VIS ≥Median)
Ø Low dose vasopressor groups (VIS< Median)
Agreementbetween measurements will be defined according to the Association for theAdvancement of Medical Instrumentation (AAMI) standards (mean of thedifferences of ≤5 mmHg with a SD of ≤8 mmHg)
Measurementswill be compared using Bland-Altman and Error Grid analyses.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •All acutely admitted patients of 18 years & older, with an expected ICU stay of at least 24 hours, in whom arterial line has already been placed for medical reasons.
排除标准
- •Contraindication to cuff application/inflation (e.g., arm injuries, burns or wounds).
结局指标
主要结局
To evaluate the agreement between blood pressure measurements obtained with non-invasive oscillometry (test method) and arterial catheter-derived measurements (reference method).
时间窗: The first measurement will be taken within 48 hours of placement of arterial line.
次要结局
- To compare degree of agreement between two methods separately in patients on high dose vasopressor, low dose vasopressor and patients who are not on vasopressors.(All the measurements will be taken within 7 days of inclusion in the study)