Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 5:15 AM
Study NCT ID:
NCT04605133
Status:
UNKNOWN
Last Update Posted:
2021-07-21
First Post:
2020-10-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrical Impedance Tomography Monitoring and Invasive Mechanical Ventilation During Pronation in Acute Respiratory Distress Syndrome.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-20', 'studyFirstSubmitDate': '2020-10-06', 'studyFirstSubmitQcDate': '2020-10-22', 'lastUpdatePostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pronation and Regions of Interest increase in percentage', 'timeFrame': '1 hour after supination', 'description': 'Demonstrate that pronation, without any recruitment maneuver, augments the dorsal regions of interest of 5%.'}], 'secondaryOutcomes': [{'measure': 'PaO2/FiO2 ratio and ventral/dorsal Regions of Interest ratio', 'timeFrame': '1 hour after supination', 'description': "Obtain a statistical significant increase of PaO2/FiO2 ratio, with a consensual decrease of the ventral/dorsal Region of Interest ratio. It'a a measure of the difference between two ratios."}, {'measure': 'Homogeneity of the ventral and dorsal regions from 0 to 1', 'timeFrame': '1 hour after supination', 'description': 'Verify in which of the 4 measurements (T0-T1-T2-T3) the ventral/dorsal Region of Interest ratio is closer to 1, which means a complete homogeneity of the ventral and dorsal regions.'}, {'measure': 'Region of Interest ratio and days of mechanical ventilation.', 'timeFrame': '30 days after pronation', 'description': 'Understand if there is an association between ROI ratio and the days of mechanical ventilation.'}, {'measure': 'Region of Interest ratio and length of stay in intensive care unit', 'timeFrame': '30 days after pronation', 'description': 'Understand if there is an association between ROI ratio and the length of stay in intensive care unit.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ARDS, Human']}, 'referencesModule': {'references': [{'pmid': '22797452', 'type': 'BACKGROUND', 'citation': 'ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.'}, {'pmid': '25985386', 'type': 'BACKGROUND', 'citation': 'Mauri T, Eronia N, Abbruzzese C, Marcolin R, Coppadoro A, Spadaro S, Patroniti N, Bellani G, Pesenti A. Effects of Sigh on Regional Lung Strain and Ventilation Heterogeneity in Acute Respiratory Failure Patients Undergoing Assisted Mechanical Ventilation. Crit Care Med. 2015 Sep;43(9):1823-31. doi: 10.1097/CCM.0000000000001083.'}, {'pmid': '26397017', 'type': 'BACKGROUND', 'citation': "Cinnella G, Grasso S, Raimondo P, D'Antini D, Mirabella L, Rauseo M, Dambrosio M. Physiological Effects of the Open Lung Approach in Patients with Early, Mild, Diffuse Acute Respiratory Distress Syndrome: An Electrical Impedance Tomography Study. Anesthesiology. 2015 Nov;123(5):1113-21. doi: 10.1097/ALN.0000000000000862."}, {'pmid': '27400909', 'type': 'BACKGROUND', 'citation': 'Scholten EL, Beitler JR, Prisk GK, Malhotra A. Treatment of ARDS With Prone Positioning. Chest. 2017 Jan;151(1):215-224. doi: 10.1016/j.chest.2016.06.032. Epub 2016 Jul 8.'}]}, 'descriptionModule': {'briefSummary': "Acute respiratory distress syndrome is an acute form of lung injury. The most commonly used classification criteria for this syndrome are Berlin's Criteria. The actual literature underlines the advantages of prone position in mild or severe forms of ARDS in association with invasive mechanical ventilation. The hypothesis of this study is to investigate the effective ventilation and perfusion modifications during pronation assessed with clinical parameters and with the aid of the electrical impedance tomography."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients' anthropometric data were collected. Ventilation parameters, electric impedence tomography parameters and blood gas analysis values were collected four times: patient supine (T0), one hour after pronation (T1), sixteen hours after pronation (T2), one hour after supination (T3).", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* mild or severe ARDS according to Berlin's Criteria\n* recruitment maximum 72 hours from the diagnosis of ARDS\n\nExclusion Criteria:\n\n* other non-ARDS respiratory system pathologies\n* hemodynamic instability (mean arterial pressure \\< 60 mmHg)\n* pneumothorax\n* endocranial hypertension\n* skin lesions or burns\n* presence of pacemaker or implantable defibrillator\n* pregnancy"}, 'identificationModule': {'nctId': 'NCT04605133', 'briefTitle': 'Electrical Impedance Tomography Monitoring and Invasive Mechanical Ventilation During Pronation in Acute Respiratory Distress Syndrome.', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Sanitaria-Universitaria Integrata di Udine'}, 'officialTitle': 'Electrical Impedance Tomography Monitoring and Invasive Mechanical Ventilation During Pronation in Acute Respiratory Distress Syndrome.', 'orgStudyIdInfo': {'id': 'EIT during pronation in ARDS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ARDS', 'description': 'Patients with mild or severe ARDS necessitating of prone position during mechanical ventilation', 'interventionNames': ['Device: Electrical impedance tomography']}], 'interventions': [{'name': 'Electrical impedance tomography', 'type': 'DEVICE', 'description': 'Every patient is monitored with electrical impedance tomograpy before, during and after prone position.', 'armGroupLabels': ['ARDS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33100', 'city': 'Udine', 'country': 'Italy', 'facility': 'Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Sanitaria-Universitaria Integrata di Udine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor in Anesthesiology and Intensive Care', 'investigatorFullName': 'Luigi Vetrugno', 'investigatorAffiliation': 'Azienda Sanitaria-Universitaria Integrata di Udine'}}}}