Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT05132933
Status:
COMPLETED
Last Update Posted:
2024-01-25
First Post:
2021-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gas Exchange Derangement Physiopathology in Critically Ill Patients With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-24', 'studyFirstSubmitDate': '2021-11-23', 'studyFirstSubmitQcDate': '2021-11-23', 'lastUpdatePostDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shunt at three different levels of positive end expiratory pressure (PEEP)', 'timeFrame': '30 minutes after change of positive end expiratory pressure (PEEP) level', 'description': 'Shunt measured by arterial and mixed venous blood samples at each level of PEEP'}], 'secondaryOutcomes': [{'measure': 'Dead space at three different levels of positive end expiratory pressure (PEEP)', 'timeFrame': '30 minutes after change of positive end expiratory pressure (PEEP) level', 'description': 'Dead space measured by capnography at each level of PEEP'}, {'measure': 'Shunt and dead space at two different levels of inspiratory oxygen fraction for each level of positive end expiratory pressure (PEEP)', 'timeFrame': '30 minutes after change of positive end expiratory pressure (PEEP) level', 'description': 'Shunt measured by arterial and mixed venous blood samples and dead space measured by capnography at each level of PEEP'}, {'measure': 'Ventilation/perfusion at three different levels of positive end expiratory pressure (PEEP) assessed by electrical impedance tomography (EIT)', 'timeFrame': '30 minutes after change of positive end expiratory pressure (PEEP) level', 'description': 'Ventilation/perfusion assessed by Electrical Impedance Tomography at each level of PEEP'}, {'measure': 'Respiratory mechanics at three different levels of positive end expiratory pressure (PEEP)', 'timeFrame': '30 minutes after change of positive end expiratory pressure (PEEP) level', 'description': 'Respiratory mechanics (including esophageal pressure measurement) assessed at each level of PEEP by performing end-inspiratory and end-expiratory pauses'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '37926984', 'type': 'DERIVED', 'citation': 'Florio G, Zanella A, Slobod D, Guzzardella A, Protti I, Carlesso E, Canakoglu A, Fumagalli J, Scaravilli V, Colombo SM, Caccioppola A, Brioni M, Pesenti AM, Grasselli G. Impact of Positive End-Expiratory Pressure and FiO2 on Lung Mechanics and Intrapulmonary Shunt in Mechanically Ventilated Patients with ARDS Due to COVID-19 Pneumonia. J Intensive Care Med. 2024 May;39(5):420-428. doi: 10.1177/08850666231210485. Epub 2023 Nov 5.'}]}, 'descriptionModule': {'briefSummary': 'The study was designed to understand the pathophysiology of gas exchange derangement in critically ill patients with COVID-19. Specifically we will evaluate the effect of 3 different levels of positive end-expiratory pressure (PEEP) and two different levels of inspiratory oxygen fraction (FiO2) on gas exchange by analyzing shunt and dead space. Furthermore, complete respiratory mechanics and distribution of ventilation and perfusion by electrical impedance tomography will be assessed at each level of PEEP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted in intensive care unit for COVID-19 related Acute Respiratory Distress Syndrome (ARDS) requiring invasive mechanical ventilation\n\nExclusion Criteria:\n\n* Pregnancy\n* Hemodynamic instability (80-90 mmHg increase or 30-40 mmHg decrease systolic arterial pressure compared to baseline value or need of vasopressors to maintain systolic blood pressure higher than 85 mmHg or electrocardiogram evidence of ischemia/arrhythmias)\n* Presence of pneumothorax and/or pneumomediastinum\n* Contraindications to Electrical Impedance Tomography (pacemaker, implantable cardioverter defibrillator, thoracic drainages)'}, 'identificationModule': {'nctId': 'NCT05132933', 'briefTitle': 'Gas Exchange Derangement Physiopathology in Critically Ill Patients With COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Policlinico Hospital'}, 'officialTitle': 'Gas Exchange Derangement Physiopathology and Response to Different Levels of Positive End-expiratory Pressure in Critically Ill Patients With COVID-19', 'orgStudyIdInfo': {'id': 'COVID-19-SHUNT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Shunt-group', 'description': 'Test of three different levels of positive end-expiratory pressure (PEEP)', 'interventionNames': ['Procedure: PEEP trial - Electrical Impedance Tomography']}], 'interventions': [{'name': 'PEEP trial - Electrical Impedance Tomography', 'type': 'PROCEDURE', 'description': 'Three different levels of PEEP and two different levels of FiO2 will be tested without changing anything else in the baseline patient ventilation', 'armGroupLabels': ['Shunt-group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Ospedale Maggiore Policlinico', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Giacomo Grasselli, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Policlinico Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Professor', 'investigatorFullName': 'Giacomo Grasselli', 'investigatorAffiliation': 'Policlinico Hospital'}}}}