Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-01-11 @ 2:50 PM
Study NCT ID:
NCT03351920
Status:
COMPLETED
Last Update Posted:
2020-02-07
First Post:
2017-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ventilation's Parameters Applied in Emergency Medicine. A Prospective Observational Study
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012121', 'term': 'Respiration, Artificial'}], 'ancestors': [{'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012151', 'term': 'Resuscitation'}, {'id': 'D004638', 'term': 'Emergency Treatment'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 229}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-06', 'studyFirstSubmitDate': '2017-10-24', 'studyFirstSubmitQcDate': '2017-11-21', 'lastUpdatePostDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients benefiting of a early low-volume ventilation initiated Emergency Department or Prehospital Care.', 'timeFrame': 'Day 1', 'description': 'Early Low volume ventilation will be defined according to a VtE \\< 8mL/lg'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients benefiting of an early protective ventilation in Emergency Departments', 'timeFrame': 'Day 1'}, {'measure': 'Proportion of patients with acute respiratory distress syndrome according to the Berlin Definition during the first eight days of following.', 'timeFrame': 'from Day 1 to Day 8 and Day 28', 'description': 'ARDS will be defined according to the Berlin definition.'}, {'measure': 'Proportion of survival from day 1 to Day 8, and to day 28', 'timeFrame': 'from Day 1 to Day 8 and Day 28'}, {'measure': 'Indication to mechanical ventilation in Prehospital care and Emergency Departments', 'timeFrame': 'Day 1'}, {'measure': 'Mechanical Ventilation Duration in Emergency Departments', 'timeFrame': 'Day 1'}, {'measure': 'Mechanical ventilation settings in Emergency Departments', 'timeFrame': 'Day 1', 'description': 'Recorded settings will be Ventilation mode, Tidal volume or Pressure Support Positive End Expiratory Pressure, Ventilation Rate, I : E ratio or Inspiratory Flow or Inspiratory Time.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mechanical Ventilation', 'Acute Respiratory Distress Syndrome', 'Protective Ventilation', 'Survival']}, 'descriptionModule': {'briefSummary': 'To prospectively assess the mechanical ventilation management when its provided by Emergency Physicians in French Hospital, and to assess complications and outcome of these patients.\n\nThe study could be measure the proportion of patients developing an Acute Respiratory Failure Distress after a take care of by French Emergency Departments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who need an invasive or non invasive mechanical ventilation, initiated in Prehospital or IntraHospital Emergency Department by an emergency Physician', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age equal or over 18 years old\n* Needing a invasive or noninvasive mechanical ventilation\n* Mechanical ventilation initiated in Prehospital or IntraHospital Emergency Department by an Emergency Physician\n\nExclusion Criteria:\n\n\\- Age under 18 years old'}, 'identificationModule': {'nctId': 'NCT03351920', 'acronym': 'PARAVENT', 'briefTitle': "Ventilation's Parameters Applied in Emergency Medicine. A Prospective Observational Study", 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'officialTitle': "Ventilation's Parameters Applied in Emergency Medicine. Observational Study", 'orgStudyIdInfo': {'id': 'PARAVENT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'mechanical ventilation', 'type': 'OTHER', 'description': 'All patients who need an invasive or non invasive mechanical ventilation, initiated in Prehospital or IntraHospital Emergency Department by an emergency Physician'}]}, 'contactsLocationsModule': {'locations': [{'zip': '47600', 'city': 'Agen', 'country': 'France', 'facility': 'Pierre-Arnaud Fort', 'geoPoint': {'lat': 44.20199, 'lon': 0.62055}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '29200', 'city': 'Brest', 'country': 'France', 'facility': 'Pierre-Marie Noël', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '17000', 'city': 'La Rochelle', 'country': 'France', 'facility': 'Paul Fievet', 'geoPoint': {'lat': 46.16308, 'lon': -1.15222}}, {'zip': '56322', 'city': 'Lorient', 'country': 'France', 'facility': 'Thomas Lenormand', 'geoPoint': {'lat': 47.74817, 'lon': -3.37177}}, {'zip': '79000', 'city': 'Niort', 'country': 'France', 'facility': 'CH de Niort', 'geoPoint': {'lat': 46.32313, 'lon': -0.45877}}, {'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'Marjanovic Nicolas', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}