Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2026-02-23 @ 4:55 AM
Study NCT ID:
NCT02070666
Status:
TERMINATED
Last Update Posted:
2020-06-19
First Post:
2014-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventive Strategies in Acute Respiratory Distress Syndrome (ARDS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}, {'id': 'D012126', 'term': 'Respiratory Dead Space'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'whyStopped': 'Low recruitment and published data with no benefit', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-17', 'studyFirstSubmitDate': '2014-02-19', 'studyFirstSubmitQcDate': '2014-02-21', 'lastUpdatePostDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ARDS development', 'timeFrame': '7 days', 'description': 'To determine the effect of a protective mechanical ventilation strategy using lower tidal volumes as compared to mechanical ventilation using traditionally-sized tidal volumes on development of ARDS.'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '90 days', 'description': 'In-hospital mortality, 28-day mortality and 90-day mortality'}, {'measure': 'Ventilator-free days', 'timeFrame': '28 days after admission', 'description': 'From 1 to 28 days over 28 days in a month'}, {'measure': 'Dead space', 'timeFrame': '7 days', 'description': 'Volumetric capnography'}, {'measure': 'Length of stay', 'timeFrame': 'participants will be followed for the duration of ICU (Intensive Care Unit) and hospital stay, an expected average of 4 weeks', 'description': 'ICU stay and hospital stay'}, {'measure': 'Pneumonia', 'timeFrame': '7 days', 'description': 'Incidence of pneumonia'}, {'measure': 'Atelectasis', 'timeFrame': '7 days', 'description': 'Incidence of atelectasis'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ARDS', 'Prevention', 'Protective mechanical ventilation', 'low tidal volumes'], 'conditions': ['ARDS']}, 'referencesModule': {'references': [{'pmid': '37351068', 'type': 'DERIVED', 'citation': 'de Haro C, Neto AS, Goma G, Gonzalez ME, Ortega A, Forteza C, Frutos-Vivar F, Garcia R, Simonis FD, Gordo-Vidal F, Suarez D, Schultz MJ, Artigas A. Effect of a low versus intermediate tidal volume strategy on pulmonary complications in patients at risk of acute respiratory distress syndrome-a randomized clinical trial. Front Med (Lausanne). 2023 Jun 7;10:1172434. doi: 10.3389/fmed.2023.1172434. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesis is that patients at risk of ARDS, detected by LIPS (Lung Injury Prediction Score), under mechanical ventilation could benefit from a protective ventilatory strategy (used in ARDS treatment) in order to avoid or decrease the ARDS development. This would lead to a decrease in incidence, mortality and health care costs associated to this syndrome.\n\nThis study will help to confirm the current evidence about low tidal volumes, evaluating adverse events of this strategy.', 'detailedDescription': 'The main objective is to evaluate the effect of a protective ventilatory strategy by using lower tidal volumes compared to the use of traditionally volumes in ARDS development.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients within 12 hours after start of invasive mechanical ventilation (MV) and admitted to participating ICU (it is recommended an inclusion as soon as possible during the first 3 hours).\n* LIPS \\> 4 points.\n* Absence of mild, moderate and severe ARDS criteria (Berlin definition).\n* Older than 18 year-old.\n* Signed informed consent\n\nExclusion Criteria:\n\n* Bilateral pulmonary infiltrates in chest X-ray at admission.\n* Mechanical ventilation \\> 12 hours.\n* Previous pneumonectomy or lobectomy.\n* Severe cranial trauma (Glasgow Coma Scale\\<9) or cranial hypertension.\n* Severe chronic pulmonary disease (GOLD IV).\n* Admission from other hospital under MV.\n* Limitation of therapeutic effort.\n* Pregnancy.\n* Acute pulmonary embolism.\n* Participation in other interventional trials.\n* Previous randomized in the proposed trial.\n* Absence of informed consent.'}, 'identificationModule': {'nctId': 'NCT02070666', 'acronym': 'EPALI', 'briefTitle': 'Preventive Strategies in Acute Respiratory Distress Syndrome (ARDS)', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': 'Preventive Strategies in Acute Respiratory Distress Syndrome', 'orgStudyIdInfo': {'id': 'EPALI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Protective ventilation arm', 'description': '* Low tidal volumes (from 4 to 6 milliliters(mL)/kilogram (kg) of predicted body weight (PBW)\n* Plateau pressure less than 25 centimeter of water (cmH2O)\n* Minimum PEEP of 5 cmH2O.', 'interventionNames': ['Behavioral: Protective mechanical ventilation', 'Other: Dead space']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Traditional-sized tidal volumes (from 8 to 10 mL/kg PBW)\n\n* Plateau pressure less than 25 cmH2O\n* Minimum PEEP of 5 cmH2O.', 'interventionNames': ['Behavioral: Control group', 'Other: Dead space']}], 'interventions': [{'name': 'Protective mechanical ventilation', 'type': 'BEHAVIORAL', 'description': 'Ventilation mode: volume control, pressure control, dual modes (It is allowed to change to a spontaneous mode; a minimum of 5 cmH2O level of support should be used; in case the resulting tidal volume exceeds 6 mL/kg PBW this is accepted. This is not a reason to use more sedation and/or muscle relaxants, or to switch the ventilator to a controlled mode of ventilation).\n\n* Tidal volume: 6 mL/Kg PBW, decreasing 1 mL/kg PBW each step if necessary (steps of 5 minutes), to maintain plateau pressure \\< 25 cmH2O until a minimum tidal volume of 4 mL/Kg PBW, unless the patient suffers from severe dyspnea or unacceptable acidosis.\n* Fraction of inspired oxygen inspired oxygen fraction (FiO2) \\> 0.21 to maintain oxygen saturation 90-92%.\n* PEEP ≥ 5 cmH2O, and optimized to maintain Oxygen saturation (SpO2) 90-92% (left to the discretion of the attending physician).\n* Plateau pressure ≤ 25 cmH2O', 'armGroupLabels': ['Protective ventilation arm']}, {'name': 'Control group', 'type': 'BEHAVIORAL', 'description': 'Ventilation mode: volume control, pressure control, dual modes (It is allowed to change to a spontaneous mode, with the level of support adjusted to reach tidal volumes minimum of 8 mL/kg predicted body weight PBW; if it is not possible, the data collection should be continue and an intention-to-treat analysis will be done).\n\n* Tidal volume: minimum 8 mL/kg PBW. It is possible to increase until 10 mL/kg PBW unless plateau pressure increases above 25 cmH2O.\n\n · FiO2 \\> 0.21 to maintain oxygen saturation 90-92%.\n* PEEP ≥ 5 cmH2O, and optimized to maintain SpO2 90-92% (left to the discretion of the attending physician).\n* Plateau pressure ≤ 25 cm H2O.', 'armGroupLabels': ['Control group']}, {'name': 'Dead space', 'type': 'OTHER', 'description': 'Volumetric capnography will be used. Dead space (Vd/Vt) measurements will be taken at baseline and daily after initiation of mechanical ventilation. Nursing and respiratory care activities (including changes to ventilator settings) will be suspended for at least 5 minutes prior to all Vd/Vt measurements.', 'armGroupLabels': ['Control group', 'Protective ventilation arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de Sabadell, CSUPT', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Critical Care Arrea', 'investigatorFullName': 'Antonio Artigas Raventós', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}