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Clinical Trials/NCT05462600
NCT05462600
Enrolling By Invitation
Not Applicable

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

University of California, San Diego1 site in 1 country40 target enrollmentJuly 19, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Disease
Sponsor
University of California, San Diego
Enrollment
40
Locations
1
Primary Endpoint
Distribution of ventilation
Status
Enrolling By Invitation
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 19, 2022
End Date
December 30, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alex Pearce

Principal Investigator

University of California, San Diego

Eligibility Criteria

Inclusion Criteria

  • 18 years or older
  • Non-smokers

Exclusion Criteria

  • \<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

Outcomes

Primary Outcomes

Distribution of ventilation

Time Frame: 3 hours

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

Respiratory drive

Time Frame: 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.

Secondary Outcomes

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

Study Sites (1)

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