Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-27 @ 9:43 PM
Study NCT ID:
NCT05081895
Status:
COMPLETED
Last Update Posted:
2024-12-10
First Post:
2021-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ventilation and Perfusion in the Respiratory System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D055370', 'term': 'Lung Injury'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2021-09-09', 'studyFirstSubmitQcDate': '2021-10-05', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'In-hospital Mortality', 'timeFrame': 'Up to 28 days', 'description': 'Mortality at 28 days after study enrollment'}, {'measure': 'ICU Mortality', 'timeFrame': 'Up to 28 days', 'description': 'ICU Mortality'}, {'measure': 'Ventilator-free days', 'timeFrame': 'Up to 28 days', 'description': 'Ventilator-free days'}, {'measure': 'Ventilator associated pneumonia', 'timeFrame': 'Up to 28 days', 'description': 'Incidence of ventilator associated pneumonia'}], 'primaryOutcomes': [{'measure': 'Distribution of ventilation', 'timeFrame': 'change from baseline at 15 minutes and 1 hour', 'description': 'Regional ventilation distribution differences measured through electrical impedance tomography (EIT)'}], 'secondaryOutcomes': [{'measure': 'Lung mechanics', 'timeFrame': 'Baseline, then at 15 minutes and 1 hour', 'description': 'Lung compliance'}, {'measure': 'Oxygenation', 'timeFrame': 'Up to 48 hours', 'description': '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)'}, {'measure': 'Blood Gas Partial Pressure of Carbon Dioxide (PaCO2) (mmHg)', 'timeFrame': 'Up to 48 hours', 'description': 'Partial pressure of carbon dioxide (PaCO2) (mmHg)'}, {'measure': 'Blood Gas pH', 'timeFrame': 'Up to 48 hours', 'description': 'Blood Gas pH'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Failure', 'Respiratory Distress Syndrome, Adult', 'Critical Illness', 'Pulmonary Disease', 'Ventilator-Induced Lung Injury']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* admitted to UC San Diego La Jolla or Hillcrest Campus Intensive Care Units\n* Patient requiring supplemental oxygen (including but no limited to nasal cannula, high flow devices, noninvasive positive pressure ventilation or mechanical ventilation\n\nExclusion Criteria:\n\n* \\<18 years\n* Chest wall, anatomical, physical abnormalities, skin integrity issues precluding placement of electrode belt in direct contact with skin\n* Patient is too unstable to position the belt/electrodes or tolerate head of bed changes\n* Confirmed or suspected intracranial bleed, stroke, edema\n* Active implants (i.e. implantable electronic devices such as pacemakers, cardioverter defibrillators, neurostimulators) or if device compatibility is in doubt\n* Pregnant or lactating patients as safety and efficacy for use of EIT in such cases has not been verified'}, 'identificationModule': {'nctId': 'NCT05081895', 'briefTitle': 'Ventilation and Perfusion in the Respiratory System', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Ventilation and Perfusion in the Respiratory System', 'orgStudyIdInfo': {'id': '210285'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Respiratory failure', 'interventionNames': ['Device: Electrical Impedance tomography', 'Other: Lung mechanics and gas exchange']}], 'interventions': [{'name': 'Electrical Impedance tomography', 'type': 'DEVICE', 'description': 'Patients will be monitored with electrical impedance tomography during routine care with special attention to effects of neuromuscular blockade and postural changes.', 'armGroupLabels': ['Respiratory failure']}, {'name': 'Lung mechanics and gas exchange', 'type': 'OTHER', 'description': 'Patient lung mechanics and gas exchange will be monitored during routine clinical care, with specific attention to postural changes and use of neuromuscular blockade.', 'armGroupLabels': ['Respiratory failure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego Health', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'overallOfficials': [{'name': 'Alex Pearce, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Reasonable requests for IPD will be considered by the investigators'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alex Pearce', 'investigatorAffiliation': 'University of California, San Diego'}}}}