Ventilation and Perfusion in the Respiratory System

Critical Illness Clinical Trial

Official title:

Ventilation and Perfusion in the Respiratory System

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05081895
• Other study ID #: 210285
• Status: Enrolling by invitation
• Start date: August 19, 2021
• Est. completion date: July 2024

Study information

• Verified date: December 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Critical Illness
• Lung Injury
• Pulmonary Disease
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Respiratory Failure
• Respiratory Insufficiency
• Ventilator-Induced Lung Injury

Intervention

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.

Locations

Country	Name	City	State
United States	University of California San Diego Health	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	In-hospital Mortality	Mortality at 28 days after study enrollment	Up to 28 days
Other	ICU Mortality	ICU Mortality	Up to 28 days
Other	Ventilator-free days	Ventilator-free days	Up to 28 days
Other	Ventilator associated pneumonia	Incidence of ventilator associated pneumonia	Up to 28 days
Primary	Distribution of ventilation	Regional ventilation distribution differences measured through electrical impedance tomography (EIT)	change from baseline at 15 minutes and 1 hour
Secondary	Lung mechanics	Lung compliance	Baseline, then at 15 minutes and 1 hour
Secondary	Oxygenation	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)	Up to 48 hours
Secondary	Blood Gas Partial Pressure of Carbon Dioxide (PaCO2) (mmHg)	Partial pressure of carbon dioxide (PaCO2) (mmHg)	Up to 48 hours
Secondary	Blood Gas pH	Blood Gas pH	Up to 48 hours