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Ventilation and Perfusion in the Respiratory System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05081895
Recruitment Status : Enrolling by invitation
First Posted : October 18, 2021
Last Update Posted : October 18, 2021
Sponsor:
Information provided by (Responsible Party):
Alex Pearce, University of California, San Diego

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.

Condition or disease Intervention/treatment
Respiratory Failure Respiratory Distress Syndrome, Adult Critical Illness Pulmonary Disease Ventilator-Induced Lung Injury Device: Electrical Impedance tomography Other: Lung mechanics and gas exchange

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Ventilation and Perfusion in the Respiratory System
Actual Study Start Date : August 19, 2021
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024


Group/Cohort Intervention/treatment
Respiratory failure Device: Electrical Impedance tomography
Patients will be monitored with electrical impedance tomography during routine care with special attention to effects of neuromuscular blockade and postural changes.

Other: Lung 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Human subjects admitted to the UC San Diego La Jolla Campus and Hillcrest Campus Intensive Care Units who are admitted with a pathologic condition requiring supplemental oxygen (including but not limited to nasal cannula, high flow devices), noninvasive positive pressure ventilation, mechanical ventilation.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05081895


Locations
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United States, California
University of California San Diego Health
La Jolla, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Alex Pearce, MD University of California, San Diego
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Responsible Party: Alex Pearce, Principal Investigator, University of California, San Diego
ClinicalTrials.gov Identifier: NCT05081895    
Other Study ID Numbers: 210285
First Posted: October 18, 2021    Key Record Dates
Last Update Posted: October 18, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Reasonable requests for IPD will be considered by the investigators

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Insufficiency
Lung Injury
Acute Lung Injury
Ventilator-Induced Lung Injury
Critical Illness
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Disease Attributes
Pathologic Processes
Thoracic Injuries
Wounds and Injuries