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Ventilation and Perfusion in the Respiratory System

Ventilation and Perfusion in the Respiratory System

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05081895
Enrollment
16
Registered
2021-10-18
Start date
2021-08-19
Completion date
2023-12-18
Last updated
2024-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Pulmonary Disease, Respiratory Distress Syndrome, Adult, Respiratory Failure, Ventilator-Induced Lung Injury

Brief summary

Respiratory failure occurs when the lung fails to perform one or both of its roles in gas exchange; oxygenation and/or ventilation. Presentations of respiratory failure can be mild requiring supplemental oxygen via nasal cannula to more severe requiring invasive mechanical ventilation as see in acute respiratory distress syndrome (ARDS).It is important to provide supportive care through noninvasive respiratory support devices but also to minimize risk associated with those supportive devices such as ventilator induced lung injury (VILI) and/or patient self-inflicted lung injury (P-SILI). Central to risk minimization is decreasing mechanical stress and strain and optimizing transpulmonary pressure or the distending pressure across the lung, minimizing overdistention and collapse. Patient positioning impacts ventilation/perfusion and transpulmonary pressure. Electrical impedance tomography (EIT) is an emerging technology that offers a noninvasive, real-time, radiation free method to assess distribution of ventilation at the bedside. The investigators plan to obtain observational data regarding distribution of ventilation during routine standard of care in the ICU, with special emphasis on postural changes and effects of neuromuscular blockade, to provide insight into ventilation/perfusion matching, lung mechanics in respiratory failure, other pulmonary pathological processes.

Interventions

DEVICEElectrical Impedance tomography

Patients will be monitored with electrical impedance tomography during routine care with special attention to effects of neuromuscular blockade and postural changes.

OTHERLung mechanics and gas exchange

Patient lung mechanics and gas exchange will be monitored during routine clinical care, with specific attention to postural changes and use of neuromuscular blockade.

Sponsors

University of California, San Diego
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18 years or older * admitted to UC San Diego La Jolla or Hillcrest Campus Intensive Care Units * Patient requiring supplemental oxygen (including but no limited to nasal cannula, high flow devices, noninvasive positive pressure ventilation or mechanical ventilation

Exclusion criteria

* \<18 years * Chest wall, anatomical, physical abnormalities, skin integrity issues precluding placement of electrode belt in direct contact with skin * Patient is too unstable to position the belt/electrodes or tolerate head of bed changes * Confirmed or suspected intracranial bleed, stroke, edema * Active implants (i.e. implantable electronic devices such as pacemakers, cardioverter defibrillators, 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

Design outcomes

Primary

MeasureTime frameDescription
Distribution of ventilationchange from baseline at 15 minutes and 1 hourRegional ventilation distribution differences measured through electrical impedance tomography (EIT)

Secondary

MeasureTime frameDescription
Lung mechanicsBaseline, then at 15 minutes and 1 hourLung compliance
OxygenationUp to 48 hoursOxygen saturation measured by pulse oximetry (SpO2) and fraction of inspired oxygen (FiO2) as well as arterial blood gas partial pressure of oxygen (PaO2). Results will be reported as either PaO2/FiO2 ratio or SpO2/FiO2 ratio (depending on availability of arterial blood gas measurements)
Blood Gas Partial Pressure of Carbon Dioxide (PaCO2) (mmHg)Up to 48 hoursPartial pressure of carbon dioxide (PaCO2) (mmHg)
Blood Gas pHUp to 48 hoursBlood Gas pH

Other

MeasureTime frameDescription
ICU MortalityUp to 28 daysICU Mortality
Ventilator-free daysUp to 28 daysVentilator-free days
Ventilator associated pneumoniaUp to 28 daysIncidence of ventilator associated pneumonia
In-hospital MortalityUp to 28 daysMortality at 28 days after study enrollment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026