Ventilation and Perfusion in the Respiratory System

Sponsor

University of California, San Diego (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05081895

Collaborator

(none)

Enrollment

Location

34.4

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Respiratory Failure Respiratory Distress Syndrome, Adult Critical Illness Pulmonary Disease Ventilator-Induced Lung Injury	Device: Electrical Impedance tomography Other: Lung mechanics and gas exchange

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Ventilation and Perfusion in the Respiratory System

Actual Study Start Date :

Aug 19, 2021

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Distribution of ventilation [change from baseline at 15 minutes and 1 hour]
Regional ventilation distribution differences measured through electrical impedance tomography (EIT)

Secondary Outcome Measures

Lung mechanics [Baseline, then at 15 minutes and 1 hour]
Lung compliance
Oxygenation [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)
Blood Gas Partial Pressure of Carbon Dioxide (PaCO2) (mmHg) [Up to 48 hours]
Partial pressure of carbon dioxide (PaCO2) (mmHg)
Blood Gas pH [Up to 48 hours]
Blood Gas pH

Other Outcome Measures

In-hospital Mortality [Up to 28 days]
Mortality at 28 days after study enrollment
ICU Mortality [Up to 28 days]
ICU Mortality
Ventilator-free days [Up to 28 days]
Ventilator-free days
Ventilator associated pneumonia [Up to 28 days]
Incidence of ventilator associated pneumonia

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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