Ventilation and Perfusion in the Respiratory System

NCT05081895 | Completed

• 1 other identifier: 210285
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Distribution of ventilation

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

  change from baseline at 15 minutes and 1 hour

Secondary Outcomes (4)

• Lung mechanics

  Baseline, then at 15 minutes and 1 hour

• Oxygenation

  Up to 48 hours

• Blood Gas Partial Pressure of Carbon Dioxide (PaCO2) (mmHg)

  Up to 48 hours

• Blood Gas pH

  Up to 48 hours

Other Outcomes (4)

• In-hospital Mortality

  Up to 28 days

• ICU Mortality

  Up to 28 days

• Ventilator-free days

  Up to 28 days

Study Arms (1)

Respiratory failure

Device: Electrical Impedance tomography; Other: Lung mechanics and gas exchange

Interventions

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.

Respiratory failure

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.

Respiratory failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego Health

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Respiratory Distress Syndrome; Critical Illness; Lung Diseases; Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Injury

Study Officials

• Alex Pearce, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: October 18, 2021
• Study Start: August 19, 2021
• Primary Completion: December 18, 2023
• Study Completion: December 18, 2023
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

US (1)