Clinical trial NCT05081895: Ventilation and Perfusion in the Respiratory System
Official title: Ventilation and Perfusion in the Respiratory System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Failure
Respiratory Distress Syndrome, Adult
Critical Illness
Pulmonary Disease
Ventilator-Induced Lung Injury
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Distribution of ventilation
timeFrame: change from baseline at 15 minutes and 1 hour
Secondary outcomes:
measure: Lung mechanics
timeFrame: Baseline, then at 15 minutes and 1 hour
measure: Oxygenation
timeFrame: Up to 48 hours
measure: Blood Gas Partial Pressure of Carbon Dioxide (PaCO2) (mmHg)
timeFrame: Up to 48 hours
measure: Blood Gas pH
timeFrame: Up to 48 hours
Other outcomes:
measure: In-hospital Mortality
timeFrame: Up to 28 days
measure: ICU Mortality
timeFrame: Up to 28 days
measure: Ventilator-free days
timeFrame: Up to 28 days
measure: Ventilator associated pneumonia
timeFrame: Up to 28 days
Locations:
city: La Jolla
country: United States
facility: University of California San Diego Health
state: California
Study officials:
affiliation: University of California, San Diego
name: Alex Pearce, MD
role: PRINCIPAL_INVESTIGATOR
References: