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Enrolling by invitation NCT05462600

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

— Observational Pulmonary Disease Respiratory System Abnormalities OSA Respiratory Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Position change.
Who it may be relevant to
Registry conditions: Pulmonary Disease, Respiratory System Abnormalities, OSA, Respiratory Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Other Position change
    Distribution of ventilation, respiratory drive, pulmonary mechanics and gas exchange will be measured in 3 unique positions: prone, head of bed (HOB) flat (i.e. 0 degrees) and HOB elevated (i.e. 30 degrees).

Primary outcome measures

  • Distribution of ventilation [Time frame: 3 hours]
  • Respiratory drive [Time frame: 3 hours]
  • Respiratory drive [Time frame: 3 hours]
  • Respiratory drive [Time frame: 3 hours]
Secondary outcome measures (3)
  • Pulmonary mechanics [Time frame: 3 hours]
  • Dead space fraction [Time frame: 3 hours]
  • Ventilatory ratio [Time frame: 3 hours]

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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of California San Diego Health — La Jolla

Identifiers

NCT: NCT05462600 · 801980

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗