Ventilation and Perfusion in the Respiratory System

Completed

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

• Registration Number: NCT05081895
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-19
• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-10-05
• Study First Posted: 2021-10-18
• Primary Completion: 2023-12-18
• Study Completion: 2023-12-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Respiratory failure	Electrical Impedance tomography	-
Respiratory failure	Lung mechanics and gas exchange	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

University of California San Diego Health; 🇺🇸 La Jolla, California, United States