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临床试验/NCT00528944
NCT00528944已完成不适用

Single-Breath Measurement Underestimates Ventilatory Volume According to Emphysema Severity

Columbia University1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2006年1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
73
试验地点
1
主要终点
Difference between DLCO SB alveolar volume and the total lung volume measurement from plethysmography

研究概览

简要总结

Although single breath helium (He) dilution measurement (VASB) is currently used in pulmonary function laboratories to assess functional alveolar volume and diffusing capacity for carbon monoxide, the extent to which VASB reflects ventilatory and thoracic volume has not been prospectively determined in emphysema. We hypothesized that VASB underestimates rebreathe helium dilution volume (VARB), and plethysmographic volume (VApleth) as clinical and physiologic severity of emphysema increases.

详细描述

VASB, VARB, and VApleth were measured in 52 consecutive stable outpatients with clinical and radiographic emphysema. Thirteen patients with an obstructive ventilatory defect without emphysema (OVD) and 18 normal controls were similarly studied. All subjects underwent spirometry followed by whole body plethysmography and He dilution volume measurements; VASB and VARB order was randomized.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 81 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All outpatients between the ages of 18 and 81 years referred to the Columbia University Medical Center Pulmonary Diagnostic Unit between 1/18/06 and 7/30/07 for full pulmonary function evaluation, and with an obstructive ventilatory defect on spirometry, were considered eligible.

排除标准

  • Patients who did not want to undergo the re-breathe diffusing capacity testing
  • Patients who could not give informed consent;and
  • Patients who were too physically compromised to undergo full testing including the re-breathe maneuver as deemed by our technicians.

结局指标

主要结局

Difference between DLCO SB alveolar volume and the total lung volume measurement from plethysmography

时间窗: 10 seconds

To test the hypothesis that DLCO SB underestimates DLCO derived by the re-breathe DLCO maneuver, and that VA SB similarly underestimates VA RB. Alveolar volume derived with the two maneuvers will be compared with body plethysmography, the gold standard of total lung volume measurement in patients with emphysema.

Difference between DLCO RB alveolar volume and the total lung volume measurement from plethysmography

时间窗: 10 seconds

To test the hypothesis that DLCO SB underestimates DLCO derived by the re-breathe DLCO maneuver, and that VA SB similarly underestimates VA RB. Alveolar volume derived with the two maneuvers will be compared with body plethysmography, the gold standard of total lung volume measurement in patients with emphysema.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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