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临床试验/NCT02154412
NCT02154412已完成不适用

Mechanisms of Arterial Hypotension in Chronic Spinal Cord Injury

University of Louisville2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1
试验地点
2
主要终点
Pulmonary function test

研究概览

简要总结

This clinical study is designed to investigate the mechanisms of blood pressure regulation and respiratory motor function affected by spinal cord injury (SCI). We hypothesize that impaired blood pressure regulation in individuals with chronic SCI can be improved by restoring respiratory motor function by using Respiratory Motor Training (RMT).

详细描述

Methods & Procedures

Screening spirometry will be performed with patient sitting in his/her personal wheelchair using BreezeSuite System. Forced Vital Capacity (FVC) & Forced Expiratory Volume in 1 second (FEV1) will be obtained & expressed as the percent of the predicted value for each subject based on a database of neurologically intact individuals with no known pulmonary complaints that was derived based on gender, age, & height. Three acceptable spirograms will be obtained & the result of their best attempt will be used.

Screening Orthostatic Stress Test will be conducted in patient placed on the cardiac chair (Chair Hydraulics). The left hand will be placed in an arm sling & kept at the level of the heart throughout the study. Continuous beat-to beat arterial blood pressure will be acquired from a finger cuff placed around the left middle or index finger (Portapres-2) in supine position & when the participants is moved into the upright seated position. Supine positions will be maintained for 15 min. & upright position will be maintained for 5 min. Baseline values in supine position will be recorded during the last 5-min period just before changing to the upright position. This test will be aborted if subjects become lightheaded or symptomatic of syncope.

Spirometry & Respiratory Muscle Strength Tests: Standard spirometry will be performed in sitting position by using BreezeSuite System (MedGraphics). FVC & FEV1 will be obtained. MP45-36-871-350 Differential Pressure Transducer with UPC 2100 PC card & software (Validyne Engineering) will be used to measure the maximum inspiratory pressure (PImax) & the maximum expiratory pressure (PEmax) in sitting position. The PImax will be measured during maximal inspiratory effort beginning at near residual volume & PEmax will be measured during maximal expiratory effort starting from near total lung capacity. Subjects will be asked to use a three-way valve system with rubber tube as mouthpiece. The pressure meter incorporates a 1.5 mm diameter leak to prevent glottic closure & to reduce buccal muscle contribution during measurements. The assessment will require a sharp, forceful effort be maintained for a minimum of 2 seconds. The maximum pressure will be taken as the highest value that sustained for one second. The maximum value from three maneuvers that varied by less than 20% will be averaged. Participants will be given specific instructions prior to the test & will be verbally coached throughout the spirometry & respiratory muscle strength maneuvers.

Orthostatic Stress Test:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Non-progressive chronic Spinal Cord Injury (SCI)
  • At least 18 years old
  • Stable medical condition
  • No diseases or conditions that would contraindicate the respiratory muscle training (RMT)
  • Not ventilator-dependent for respiration
  • At least 15%-deficit in pulmonary function outcome measures
  • Orthostatic hypotension

排除标准

  • Major cardiovascular or pulmonary disease
  • Endocrine disorders
  • Malignancy
  • Pregnancy (no pregnancy test or birth control regimen will be required)

结局指标

主要结局

Pulmonary function test

时间窗: Before and after 20 sessions of RMT

Standard spirometry measures in percent predicted values

次要结局

  • Blood pressure change measurement(Before and after 20 sessions of RMT)
  • Maximum airway pressure(Before and after 20 sessions of RMT)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexander V Ovechkin, MD, PhD

Associate Professor

University of Louisville

研究点 (2)

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