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临床试验/NCT05462600
NCT05462600Enrolling By Invitation不适用

Distribution of Ventilation, Respiratory Drive and Gas Exchange: Measurements and Monitoring

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年7月19日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
40
试验地点
1
主要终点
Distribution of ventilation

研究概览

简要总结

Respiratory physiology involves a complex interplay of elements including control of breathing, respiratory drive, pulmonary mechanics, distribution of ventilation and gas exchange. Body position may also play an important role in respiratory mechanics. While effective methods exist for measuring these variables, they are typically measured in isolation rather than in combination. In pulmonary disease, decreasing mechanical stress and strain and optimizing transpulmonary pressure or the distending pressure across the lung, minimizing overdistention and collapse are central to clinical management. Obesity has a significant impact on pulmonary mechanics and is a risk factor for obstructive sleep apnea (OSA). However, our understanding of these elements is limited even in the general population. The investigators plan to use various validated methods to assess control of breathing, respiratory drive, distribution of ventilation and gas exchange to obtain a better understanding of underlying physiologic signatures in patients with and without obesity and the role of posture/position, with a secondary analysis comparing participants with and without obstructive sleep apnea.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years or older
  • Non-smokers

排除标准

  • <18 years old
  • Significant history of pulmonary disease
  • Chest wall, anatomical, physical abnormalities, skin integrity issues precluding placement of electrode belt in direct contact with skin
  • Skin integrity issues precluding placement of nose clips, or transcutaneous carbon dioxide monitoring
  • Inability to form a seal around a mouthpiece
  • Known esophageal strictures, webs, or varices (if esophageal manometry to be included)
  • Known platelet count < 100,000 (if esophageal manometry to be included)
  • On therapeutic anticoagulation (if esophageal manometry to be included)
  • Known multidrug resistant (MDR) pulmonary infection
  • Non-English language speakers
  • Chronic hypoxemic respiratory failure
  • Confirmed or suspected intracranial bleed, stroke, edema
  • Active implants (i.e. implantable electronic devices such as pacemakers, cardioverter defibrillators or neurostimulators) or if device compatibility is in doubt
  • Pregnant or lactating patients as safety and efficacy for use of EIT in such cases has not been verified

结局指标

主要结局

Distribution of ventilation

时间窗: 3 hours

Change in regional ventilation distribution (ventral/dorsal) measured through electrical impedance tomography (EIT)

Respiratory drive

时间窗: 3 hours

Respiratory drive will also be assessed by measurement of occlusion pressure (cm H2O) at 100 ms (P0.1) after the initiation of an inspiratory effort against a closed circuit.

次要结局

  • Pulmonary mechanics(3 hours)
  • Dead space fraction(3 hours)
  • Ventilatory ratio(3 hours)

研究者

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

Alex Pearce

Principal Investigator

University of California, San Diego

研究点 (1)

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