Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-01-10 @ 3:19 PM
Study NCT ID:
NCT04159220
Status:
COMPLETED
Last Update Posted:
2024-05-31
First Post:
2019-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial to Evaluate an Optimization Procedure of Alveolar Recruitment During Transport Performed by Nurse Anesthetists in Intensive Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-30', 'studyFirstSubmitDate': '2019-11-06', 'studyFirstSubmitQcDate': '2019-11-08', 'lastUpdatePostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure of the pa02/Fi02', 'timeFrame': '1 hour after the end of the transport', 'description': 'Evaluate the effectiveness of a procedure to avoid alveolar delisting, measured by the absence of a decrease in the PaO2/FiO2 ratio (before transport and 1 hour after return to bed) during an HIT performed by a nurse anaesthetist/caregiver team, of intubated and ventilated resuscitation patients in a controlled assisted volume.'}], 'secondaryOutcomes': [{'measure': 'Assessment of the pa02', 'timeFrame': '1 hour after the end of the HIT', 'description': 'Evaluate the impact of the procedure on the absence of PaO2 reduction (before transport and 1 hour after return to bed)'}, {'measure': 'Assessment of the pa02', 'timeFrame': 'immediately after the end of the HIT', 'description': 'Evaluate the effectiveness of the procedure on Pa02 immediately after reconnection to the heavy resuscitation ventilator'}, {'measure': 'Assessment of the pa02', 'timeFrame': '6 hours after the end of of the HIT', 'description': 'Evaluate the effectiveness of the procedure on Pa02 immediately after reconnection to the heavy resuscitation ventilator'}, {'measure': 'length of stay', 'timeFrame': 'up to 28 days', 'description': 'Evaluate the impact of the intervention on the length of ICU stay'}, {'measure': 'duration of invasive ventilation', 'timeFrame': 'up to 28 days', 'description': 'Evaluate the impact of the intervention on the invasive ventilation'}, {'measure': 'occurrence of adverse events during the HIT', 'timeFrame': 'immediately after the end of the HIT', 'description': 'occurrence of adverse events related to the clamping'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Complication']}, 'descriptionModule': {'briefSummary': 'Intra hospital transport of ICU patients is still at high risk of respiratory complications.We propose to determine if endotracheal tube clamping prior to disconnect ventilator allows to avoid oxygenation decrease.', 'detailedDescription': 'Changing respiratory support and multiples endotracheal tube disconnections may induce a loss of PEEP and finally lead to alveolar derecruitment. This study is an evaluation of a care procedure to limit the incidence of alveolar derecruitment in ventilated intubated ICU patients during transport for CT scan.\n\nIntra hospital transport of ICU patients are performed by anesthesiologist nurses, the physician entrusts them this activity.\n\nThis is a randomized controlled study, the procedure is to clamp endotracheal tube before each disconnection from ventilator.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* intensive care patient\n* intubated, sedated, controlled assisted ventilation\n* Intra hospital transport for CT scan\n* arterial catheter\n* the patient or his trusted person consent to the study\n\nExclusion Criteria:\n\n* Patient Covid tests positive or Covid test results not received\n* extubated, unsedated,\n* reinforced tube\n* tracheotomy\n* pregnancy\n* guardianship'}, 'identificationModule': {'nctId': 'NCT04159220', 'acronym': 'ESCORTE', 'briefTitle': 'Trial to Evaluate an Optimization Procedure of Alveolar Recruitment During Transport Performed by Nurse Anesthetists in Intensive Care', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Randomized Controlled Trial to Evaluate an Optimization Procedure of Alveolar Recruitment During Transport Performed by Nurse Anesthetists in Intensive Care', 'orgStudyIdInfo': {'id': 'RECHMPL19_0070'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The transport will be released without a clamping of endotracheal tube before each disconnection from ventilator.'}, {'type': 'EXPERIMENTAL', 'label': 'Clamping group', 'description': 'The transport will be released with a clamping of endotracheal tube before each disconnection from ventilator.', 'interventionNames': ['Procedure: Clamping of the ventilator endotracheal tube']}], 'interventions': [{'name': 'Clamping of the ventilator endotracheal tube', 'type': 'PROCEDURE', 'description': 'The transport will be released in accordance with SFAR SRLF guideline. Before each disconnection from ventilator endotracheal tube will be clamped.', 'armGroupLabels': ['Clamping group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': "Departement d'anesthésie et réanimation Gui de Chauliac (DAR C)", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': '12 months after the main publication', 'ipdSharing': 'YES', 'accessCriteria': 'Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and IRB review. Dataset will be shared after careful examination by the study board of investigators.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}