Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 1:19 AM
Study NCT ID:
NCT04390360
Status:
UNKNOWN
Last Update Posted:
2023-03-10
First Post:
2020-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Smartphone Application for Initiation of Protective Ventilation. Clinical Impact of Instrumental Dead Space Reduction
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-08', 'studyFirstSubmitDate': '2020-04-20', 'studyFirstSubmitQcDate': '2020-05-12', 'lastUpdatePostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PaCO2 Variation', 'timeFrame': '60 minutes post intervention', 'description': 'The primary outcome is to evaluate the PaCO2 variation at the end of condition 2 (after 30 minutes with protective ventilation+ HME) and condition 4 (30 minutes after Tidal volume reduction + Heater humidifier).\n\nVariation \\<= 10% of PaCO2'}, {'measure': 'PaCO2 Variation', 'timeFrame': '120 minutes post intervention', 'description': 'The primary outcome is to evaluate the PaCO2 variation at the end of condition 2 (after 30 minutes with protective ventilation+ HME) and condition 4 (30 minutes after Tidal volume reduction + Heater humidifier).\n\nVariation \\<= 10% of PaCO2'}], 'secondaryOutcomes': [{'measure': 'Correlation between PCO2 variation and alveolar ventilation variation', 'timeFrame': '60 and 90 minutes post intervention', 'description': 'We will compare PaCO2 level variation and the alveolar ventilation variation to establish correlation.\n\nCorrelation variation under 10% will be significative'}, {'measure': 'Hemodynamic impact vs pH', 'timeFrame': 'Baseline, 30, 60, 90 and 120 minutes post intervention', 'description': 'Cardiac echographic measurement (LeftVentricularEjectionFraction) in relation with acidosis status'}, {'measure': 'Hemodynamic impact vs pH', 'timeFrame': 'Baseline, 30, 60, 90 and 120 minutes post intervention', 'description': 'Cardiac echographic measurement (RightVentricularEjectionFraction) in relation with acidosis status'}, {'measure': 'Hemodynamic impact vs pH', 'timeFrame': 'Baseline, 30, 60, 90 and 120 minutes post intervention', 'description': 'Cardiac echographic measurement Arterial pulmonary pressure) in relation with acidosis status'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ARDS, Human', 'Mechanical Ventilation Complication', 'Humidifier Lung']}, 'descriptionModule': {'briefSummary': 'Clinical evaluation of a new educative tools (Smartphone application) based on impact of instrumental dead space reduction after initiation of protective ventilation during mechanical ventilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years old\n* Mechanical ventilation (control,assist control or SIMV mode)\n* haemodynamic stability (vasopressor \\< 0.2 ug/kg/min)\n* no prone position schedule in the next 2 hours following procedure inclusion\n* presence of an Arterial catheter\n\nExclusion Criteria:\n\n* ECMO or anticipate ECMO\n* body temperature \\< 36.0 for post operative patient (cardiac surgery)'}, 'identificationModule': {'nctId': 'NCT04390360', 'acronym': 'Ventilo', 'briefTitle': 'Smartphone Application for Initiation of Protective Ventilation. Clinical Impact of Instrumental Dead Space Reduction', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Development and Evaluation of Smartphone App for Initiation of Protective Ventilation. Clinical Impact of Instrumental Dead Space Reduction on Physiologic Parameter Based on the Smartphone App', 'orgStudyIdInfo': {'id': '21750'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Protective ventilation with HME', 'description': 'Protective ventilation + HME', 'interventionNames': ['Procedure: Protective ventilation with HME']}, {'type': 'OTHER', 'label': 'Protective ventilation with Heated humidifier', 'description': 'Protective ventilation + HH', 'interventionNames': ['Procedure: Protective ventilation with Heated humidifier']}, {'type': 'OTHER', 'label': 'Implementation of protective ventilation', 'description': 'Protective ventilation implementation', 'interventionNames': ['Procedure: Protective ventilation implementation']}, {'type': 'OTHER', 'label': 'Tidal Volume reduction', 'description': 'Tidal volume reduction', 'interventionNames': ['Procedure: Tidal Volume reduction']}], 'interventions': [{'name': 'Protective ventilation implementation', 'type': 'PROCEDURE', 'description': 'In this condition, we will implement the protective ventilation related with gender and height . A blood gas will be performed at before protective ventilation implementation and at the end of this condition.Time condition 30 minutes', 'armGroupLabels': ['Implementation of protective ventilation']}, {'name': 'Protective ventilation with HME', 'type': 'PROCEDURE', 'description': 'In this condition, the patient will received protective ventilation with a Heat Moisture Exchanger (HME). A blood gas will be performed at the end of this condition.Time condition 30 minutes', 'armGroupLabels': ['Protective ventilation with HME']}, {'name': 'Protective ventilation with Heated humidifier', 'type': 'PROCEDURE', 'description': 'In this condition, the patient will received protective ventilation with a Heated humidifier. A blood gas will be performed at the end of this condition.Time condition 30 minutes', 'armGroupLabels': ['Protective ventilation with Heated humidifier']}, {'name': 'Tidal Volume reduction', 'type': 'PROCEDURE', 'description': 'n this condition, we will reduce Tidal volume (with smartphone application calculation) to obtain the same alveolar ventilation (PaCO2) obtained on the HME condition', 'armGroupLabels': ['Tidal Volume reduction']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V4G5', 'city': 'Québec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Pierre-Alexandre Bouchard', 'role': 'CONTACT', 'email': 'pierre-alexandre.bouchard@criucpq.ulaval.ca', 'phone': '418-656-8711', 'phoneExt': '2712'}, {'name': 'Francois Lellouche', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'centralContacts': [{'name': 'François Lellouche', 'role': 'CONTACT', 'email': 'Francois.Lellouche@criucpq.ulaval.ca', 'phone': '1-418-656-8711'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}