Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-05 @ 5:20 PM
Study NCT ID:
NCT05922969
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2023-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Low PEEP Maneuvers During ARDS Management
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': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-09', 'studyFirstSubmitDate': '2023-06-20', 'studyFirstSubmitQcDate': '2023-06-20', 'lastUpdatePostDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of oxygen desaturation', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Respiratory distress syndrome', 'Positive end expiratory pressure'], 'conditions': ['Acute Respiratory Distress Syndrome', 'Positive End Expiratory Pressure']}, 'descriptionModule': {'briefSummary': 'Acute Respiratory distress syndrome (ARDS) is a severe condition in which protective ventilation is a critical point in its management. Positive end expiratory pressure (PEEP) setting can be challenging for clinicians and high PEEP has been associated with better outcome in moderate and severe ARDS. Recently, recruitment to inflation ratio and airway closure have been investigated in order to help PEEP adjustment. However, ventilatory maneuvers are performed with a low level of PEEP and therefore expose to derecruitment and oxygen desaturation. So far, the risk of oxygen desaturation has not been investigated and risk factors are unknown.\n\nThe aim of this study is to evaluate the prevalence of oxygen desaturation during ventilatory maneuvers at low level of PEEP in patients with moderate or severe ARDS'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'PEEP in patients with moderate or severe ARDS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age : \\> 18 yo\n* inclusion criteria: ARDS, Mechanical ventilation, low PEEP maneuvers\n\nExclusion Criteria:\n\n* refusal to participate'}, 'identificationModule': {'nctId': 'NCT05922969', 'acronym': 'DEBAS', 'briefTitle': 'Safety of Low PEEP Maneuvers During ARDS Management', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Safety of Low PEEP Maneuvers During ARDS Management', 'orgStudyIdInfo': {'id': 'PI2021_843_0165'}}, 'contactsLocationsModule': {'locations': [{'zip': '80480', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Yoann Zerbib, MD', 'role': 'CONTACT', 'email': 'zerbib.yoann@chu-amiens.fr', 'phone': '03 22 08 77 23'}, {'name': 'Yoann Zerbib', 'role': 'CONTACT', 'email': 'zerbib.yoann@chu-amiens.fr', 'phone': '03 22 08 77 23'}], 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Yoann Zerbib, MD', 'role': 'CONTACT', 'email': 'Zerbib.yoann@chu-amiens.fr', 'phone': '03 22 08 77 23'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier VALENCIENNES', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}