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OpenTrials
Completed

NCT Number: NCT05081895

Ventilation and Perfusion in the Respiratory System

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electrical impedance tomography

Device

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

Lung mechanics and gas exchange

Other

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

Primary outcomes

  1. Distribution of ventilation

    Time frame: change from baseline at 15 minutes and 1 hour

    Regional ventilation distribution differences measured through electrical impedance tomography (EIT)

Secondary outcomes

  1. Lung mechanics

    Time frame: Baseline, then at 15 minutes and 1 hour

    Lung compliance

  2. Oxygenation

    Time frame: Up to 48 hours

    Oxygen 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)

  3. Blood Gas Partial Pressure of Carbon Dioxide (PaCO2) (mmHg)

    Time frame: Up to 48 hours

    Partial pressure of carbon dioxide (PaCO2) (mmHg)

  4. Blood Gas pH

    Time frame: Up to 48 hours

    Blood Gas pH

Other outcomes

  1. In-hospital Mortality

    Time frame: Up to 28 days

    Mortality at 28 days after study enrollment

  2. ICU Mortality

    Time frame: Up to 28 days

    ICU Mortality

  3. Ventilator-free days

    Time frame: Up to 28 days

    Ventilator-free days

  4. Ventilator associated pneumonia

    Time frame: Up to 28 days

    Incidence of ventilator associated pneumonia

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 18, 2021
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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