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临床试验/NCT02557009
NCT02557009
已完成
不适用

Changes in Hemodynamic Values With Posture

Milton S. Hershey Medical Center1 个研究点 分布在 1 个国家目标入组 60 人2013年10月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Blood Pressure
发起方
Milton S. Hershey Medical Center
入组人数
60
试验地点
1
主要终点
central venous pressure supine and with head of bed at 30 degrees
状态
已完成
最后更新
8年前

概览

简要总结

The study is designed as a prospective observational study. Each participant will have their BP, CVP, PAP, and CO measured by their clinical nurse using indwelling catheters placed for routine patient monitoring. Measurements will be recorded on an hourly basis during the day and for as many days as possible if the required measurements are being made for clinical care.

Sixty patients between 18 and 85 years of age will be recruited in HVICU by means of convenience sampling. Data will be analyzed using a test of equivalence on the initial measurements (test of equivalence between two means) and then over time (repeated measurements) with a linear mixed-effects model.

详细描述

Invasive monitoring is a common method used in intensive care units to measure cardiovascular status. These parameters include central venous pressure (CVP), pulmonary artery pressure (PAP) cardiac output (CO) and arterial blood pressure (BP). There is a general understanding that these parameters vary with the position of the patient with the expectation that, as the patient goes from supine to sitting, these parameters decrease to some extent due to decreased venous return to the heart. Furthermore, the extent to which a patient might be reclining in bed can vary greatly from just having the head slightly raised to being totally upright. Different policies exist with respect to patient position when these measurements are made. The policies vary from no specified position to placing them completely flat for making the measurement and then returning them to a more upright position, usually 30 or 45 degrees. Decisions are based upon the supine measurements despite no clear correlation to the patient's usual position. This study will investigate the correlation between position and these parameters. Patients in the HVICU will be approached by a member of the research team and asked for their verbal approval to record measurements made by their nurse. After receiving verbal consent to record the measurements, a member of the study team will record BP. CVP, PAP and CO as measured by the patient's nurse. These measurements will be recorded with the patient lying on the bed with the back of the bed raised to 30o and with the patient supine when the back of the bed is at 0o. The transducers will be leveled with the anterior axillary by zeroing of the transducer. After each position change, the team member will ask the nurse to wait 5 minutes to allow stabilization of these parameters before measuring and recording the parameters at that position. These parameters will be recorded on an hourly basis using the day for as many days as the required measurements are being made for clinical care. Other patient information recorded will be date, ejection fraction, BMI, height, weight, age, and PEEP, if the patient is intubated. Sixty patients between 18 and 85 years of age will be recruited in HVICU by means of convenience sampling. The sample size was calculated based on the initial measurement of CVP where our preliminary data shows a mean difference 1.28±2.93 mmHg, and assuming that values with a difference \< 3 are equivalent, with an α = 0.05 and a power of 90. The calculation was done at the following website: http://www.sealedenvelope.com/power/continuous-equivalence. Data will be analyzed using a test of equivalence on the initial measurements (test of equivalence between two means) and then over time (repeated measurements) with a linear mixed-effects model.

注册库
clinicaltrials.gov
开始日期
2013年10月1日
结束日期
2016年7月
最后更新
8年前
研究类型
Observational
性别
All

研究者

责任方
Principal Investigator
主要研究者

Kane High

Associate Professor

Milton S. Hershey Medical Center

入排标准

入选标准

  • Adult patients (18 to 85 years of age) in the HVICU
  • Have indwelling CVP or PA catheter.

排除标准

  • Patients who have just undergone mitral valve surgery
  • Patients that have PEEP \> 10cmH2O

结局指标

主要结局

central venous pressure supine and with head of bed at 30 degrees

时间窗: 48 hours post-operatively

次要结局

  • cardiac output with head of bed at 30 degrees(48 hours post-operatively)
  • cardiac output supine(48 hours post-operatively)

研究点 (1)

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