Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT01990456
Status:
UNKNOWN
Last Update Posted:
2014-11-06
First Post:
2013-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strategies for Optimal Lung Ventilation in ECMO for ARDS: The SOLVE ARDS Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D011660', 'term': 'Pulmonary Heart Disease'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'lastUpdateSubmitDate': '2014-11-05', 'studyFirstSubmitDate': '2013-11-06', 'studyFirstSubmitQcDate': '2013-11-14', 'lastUpdatePostDateStruct': {'date': '2014-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ventilator-Induced Lung Injury (VILI) in patients with ARDS on ECMO ventilated with different strategies (tidal ventilation, CPAP, ZEEP), as measured by Serum Cytokines', 'timeFrame': '1 hour after initiation of each experimental ventilation strategy'}], 'secondaryOutcomes': [{'measure': 'Impact of a CPAP strategy (PEEP set at best compliance and at ZEEP) in patients with severe ARDS on ECMO, as measured by transesophageal echocardiography (TEE)', 'timeFrame': '30 minutes after initiation of experimental CPAP/ZEEP strategy', 'description': "Quantification of RV function:\n\n1. RVEDA/LVEDA\n2. LV end-diastolic/systolic eccentricity indexes:\n3. 2D RVFAC\n4. TAPSE\n5. Tissue Doppler-derived tricuspid lateral annular systolic velocity (S')\n6. RIMP\n7. 3D EF \\< 44%\n8. Myocardial Acceleration During Isovolumic Contraction\n9. Regional RV Strain"}, {'measure': 'Feasibility and validity of focused cardiac ultrasound, as compared to TEE as gold standard, in the assessment of RV function in patients with ARDS on ECMO', 'timeFrame': '30 minutes after initiation of experimental CPAP/ZEEP strategy', 'description': "Quantification of RV function:\n\n1. RVEDA/LVEDA\n2. TAPSE\n3. RV Annular Velocity (S')\n4. LV end-diastolic and end-systolic eccentricity indexes"}, {'measure': 'Feasibility of lung ultrasound in patients with severe ARDS on ECMO', 'timeFrame': '30 minutes after initiation of experimental CPAP/ZEEP strategy', 'description': 'Lung Ultrasound Score'}, {'measure': 'Feasibility (patient recruitment, protocol adherence, physiologic tolerability)', 'timeFrame': 'At overall study completion (i.e., 24 months from study start or after enrolment of last patient)', 'description': 'This outcome will be assessed by:\n\n* the ability to enrol the proposed patient sample within the timeframe of the study (24 months)\n* \\>90% adherence to the experimental protocol on enrolled patients\n* \\>80% completion of the entire experimental protocol on enrolled patients'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Extracorporeal Membrane Oxygenation', 'Ventilator-Induced Lung Injury', 'Ventilators, Mechanical', 'Pulmonary Heart Disease', 'Ultrasonography'], 'conditions': ['Respiratory Distress Syndrome, Adult']}, 'descriptionModule': {'briefSummary': 'Due to lack of studies on mechanical ventilation strategies in patients with severe Acute Respiratory Distress Syndrome (ARDS) supported with Veno-Venous Extra-Corporeal Membrane Oxygenation (VV ECMO), ventilator settings in this patient population are set arbitrarily.\n\nIn this two-phases prospective, interventional, pilot study we hope to gain physiologically relevant data on two aspects of mechanical ventilation in patients with severe ARDS supported with VV ECMO: (1) the use of tidal ventilation and (2) the level of Positive End-Expiratory Pressure (PEEP).\n\n1. PHASE 1: impact of tidal ventilation on VILI (10 patients) We hypothesized that a CPAP strategy that minimizes end-tidal pulmonary stress and strain mitigates VILI compared to the current mechanical ventilation practice that employs tidal ventilation in patients with severe ARDS on ECMO.\n\n In this first phase we will test whether administering a distending inspiratory pressure to produce tidal ventilation is superior to a strategy where only continuous positive airway pressure (CPAP) is applied for ventilation induced lung injury (VILI) mitigation, as assessed by its impact on biotrauma (serum cytokines) and physiologic measurements.\n2. PHASE 2: impact of PEEP on VILI (10 patients) We also hypothesized that adjusting PEEP to maximize respiratory system compliance reduces VILI in patients with severe ARDS on ECMO.\n\nIn the second phase we will therefore gain more insight as to whether a strategy that utilizes a PEEP level that correspond to best compliance is beneficial over Zero End-Expiratory Pressure (ZEEP). We will test the impact of both strategies on biotrauma (serum cytokines), physiologic parameters, and right ventricular function (transesophageal echocardiographic assessment).\n\nBecause ARDS patients supported with VV ECMO can be hemodynamically unstable, the use of imaging techniques that require transport, such as computed tomography, is limited. Therefore, bedside imaging techniques, such as pleural and lung ultrasound (PLUS) and focused bedside cardiac ultrasonography, are important tools for clinicians who care for these patients. This study will allow us to learn whether these techniques are feasible and valid in this patient population.\n\nFurthermore, the knowledge gained from this study will allow us to assess the rationale and feasibility of performing a similar larger, randomized study in the future.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe ARDS (Berlin Definition)\n* VV ECMO \\< 72 hours\n* Endotracheal intubation or tracheostomy\n\nExclusion Criteria:\n\n* Thoracic surgery/lung transplantation during the current hospitalization\n* Contraindications to a RM (MAP \\< 60 mmHg despite administration of fluids and vasopressors; Active air leak through a thoracostomy tube; Pneumothorax, or subcutaneous or mediastinal emphysema, (if chest tube has not been inserted))\n* Contraindications to TEE\n* Age \\< 16 years'}, 'identificationModule': {'nctId': 'NCT01990456', 'acronym': 'SOLVE ARDS', 'briefTitle': 'Strategies for Optimal Lung Ventilation in ECMO for ARDS: The SOLVE ARDS Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'Strategies for Optimal Lung Ventilation in ECMO for ARDS: The SOLVE ARDS Study', 'orgStudyIdInfo': {'id': 'SOLVE ARDS_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PHASE 1: impact of tidal ventilation on VILI', 'description': 'In the first phase we will test whether administering a distending inspiratory pressure to produce tidal ventilation is superior to a strategy where only continuous positive airway pressure (CPAP) is applied for ventilation induced lung injury (VILI) mitigation, as assessed by its impact on biotrauma (serum cytokines) and physiologic measurements.', 'interventionNames': ['Device: PHASE 1: impact of tidal ventilation on VILI']}, {'type': 'EXPERIMENTAL', 'label': 'PHASE 2: impact of PEEP on VILI', 'description': 'In the second phase we will gain more insight as to whether a strategy that utilizes a PEEP level that correspond to best compliance is beneficial over Zero End-Expiratory Pressure (ZEEP). We will test the impact of both strategies on biotrauma (serum cytokines), physiologic parameters, and right ventricular function (transesophageal echocardiographic assessment).', 'interventionNames': ['Device: PHASE 2: impact of PEEP on VILI']}], 'interventions': [{'name': 'PHASE 1: impact of tidal ventilation on VILI', 'type': 'DEVICE', 'description': 'PHASE 1A - Baseline - Standard Ventilation Protocol (PCV 10 cmH2O, PEEP 10 cmH2O, RR 10, FiO2 0.30) PHASE 1B - CPAP Strategy - CPAP 10 cmH2O for 1 hour PHASE 1C - Higher Tidal Ventilation Strategy (PCV 20 cmH2O, PEEP 10 cmH2O, RR 10, FiO2 0.30) PHASE 1D - Return to Baseline - Standard Ventilation Protocol', 'armGroupLabels': ['PHASE 1: impact of tidal ventilation on VILI']}, {'name': 'PHASE 2: impact of PEEP on VILI', 'type': 'DEVICE', 'description': 'PHASE 2A - Baseline - Standard Ventilation Protocol - (PCV 10 cmH2O, PEEP 10 cmH2O, RR 10, FiO2 0.30) PHASE 2B - Decremental PEEP Trial PHASE 2C - CPAP set at best compliance of respiratory system (as per decremental PEEP Trial) PHASE 2D - ZEEP PHASE 2E - Return to Baseline - Standard Ventilation Protocol', 'armGroupLabels': ['PHASE 2: impact of PEEP on VILI']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Eddy Fan, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Medical Surgical ICU - Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Fan Eddy, MD, PhD', 'role': 'CONTACT', 'email': 'Eddy.Fan@uhn.ca', 'phone': '+1 416 340 4800', 'phoneExt': '5061'}, {'name': 'Ferguson D. Niall, MD, MSc', 'role': 'CONTACT', 'email': 'Niall.Ferguson@uhn.ca', 'phone': '+1 416 586 4800', 'phoneExt': '8449'}], 'overallOfficials': [{'name': 'Eddy Fan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, University of Toronto'}, {'name': 'Niall D. Ferguson, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, University of Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Health Network, Toronto', 'class': 'OTHER'}, {'name': "The Physicians' Services Incorporated Foundation", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Eddy Fan', 'investigatorAffiliation': 'University of Toronto'}}}}