Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT06698120
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-02
First Post:
2024-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Awake Prone Positioning for Severe Acute Chest Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056586', 'term': 'Acute Chest Syndrome'}, {'id': 'D000755', 'term': 'Anemia, Sickle Cell'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2024-04-24', 'studyFirstSubmitQcDate': '2024-11-18', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The total duration of APP during the stay in intensive care unit', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Changes in respiratory parameters', 'timeFrame': 'Up to 28 days', 'description': 'Assessment of respiratory parameters changes'}, {'measure': 'GI measured by EIT', 'timeFrame': 'Up to 28 days'}, {'measure': 'ΔEELI measured by EIT', 'timeFrame': 'Up to 28 days'}, {'measure': 'Pain measurement assessed by visual analog scale,', 'timeFrame': 'Up to 28 days'}, {'measure': 'Pain measurement assessed by morphine consumption', 'timeFrame': 'Up to 28 days'}, {'measure': 'Pain measurement assessed by analgesic therapeutic escalation', 'timeFrame': 'Up to 28 days'}, {'measure': 'Occurrence of skin lesions during the intensive care unit stay', 'timeFrame': '28 Days'}, {'measure': 'Occurrence of displacement of devices during the intensive care unit stay', 'timeFrame': '28 Days'}, {'measure': 'Occurrence of use of vital support therapy during the intensive care unit stay', 'timeFrame': '28 Days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Chest Syndrome', 'Sickle Cell Anemia', 'Awake Prone Positioning', 'Electric Impedance'], 'conditions': ['Acute Chest Syndrome', 'Sickle Cell Anemia']}, 'descriptionModule': {'briefSummary': 'Acute chest syndrome (ACS) is the leading cause of admission to intensive care and the leading cause of death in patients with sickle cell disease. Irrespective of the cause of ACS, there is an heterogeneity in pulmonary ventilation/perfusion ratios, leading to worsening of the disease.\n\nEfficiency of awake prone positioning (APP) in acute respiratory failure (ARF) was particularly highlighted during the COVID-19 pandemic. Several physiological factors contribute to this benefit including an improvement in ventilatory drive and gas exchange.\n\nThe investigator hypothesize that APP could lead to clinical improvement in ACS in terms of oxygenation and ventilatory drive, by improving the heterogeneity of ventilation', 'detailedDescription': '* Several physiological mechanisms contribute to the benefit of APP during ARF. In addition to hypoxemia improvement, there is also an effect on ventilatory drive, notably in terms of polypnea, ROX index and inspiratory effort.\n* Considering that hypoxemia in ACS contributes to the physiopathological process: deoxygenation of haemoglobin S - red blood cells falciformisation - vaso-occlusive event, APP could be an additional therapy in severe ACS. In addition, improving ventilation-perfusion ratios, mainly by recruiting dorsal zones, could be particularly useful in ACS, where pulmonary damage predominates in gravito-dependent zones.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* Major sickle cell anemia (SS, SC, Sβ)\n* Admission in intensive care unit for ACS\n* Registered in the French social insurance regime.\n* Written, informed consent\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Immediate need for intubation\n* Impaired vigilance status (Glasgow scale score \\< 12)\n* Pneumothorax\n* Haemodynamically unstable\n* Thoracic trauma admission\n* Severely obese with body-mass index higher than 40 kg/m²\n* EIT contraindication: pacemaker, automatic implantable defibrillators, skin lesions facing the EIT belt, unstable rachis fracture or medullary lesions'}, 'identificationModule': {'nctId': 'NCT06698120', 'acronym': 'PRONE-ACS', 'briefTitle': 'Awake Prone Positioning for Severe Acute Chest Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Assessment of Efficacy and Safety of Awake Prone Positioning in Sickle Cell Anemia Patient Admitted in Intensive Care Unit for Severe Acute Chest Syndrome', 'orgStudyIdInfo': {'id': 'APHP231628'}, 'secondaryIdInfos': [{'id': '2023-A02167-38', 'type': 'OTHER', 'domain': 'IDRCB ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Awake prone positioning', 'interventionNames': ['Procedure: Awake prone positioning (APP)']}], 'interventions': [{'name': 'Awake prone positioning (APP)', 'type': 'PROCEDURE', 'description': '* APP are realized following the diagnosis of ACS\n* Prone positioning or supine positioning are performed under supervision of a physician or a nurse\n* Maximum session duration: 16 hours per day\n* Sessions of prone positioning can be shortened, if necessary (30 minutes minimum), for better tolerance\n* Tolerance of prone positioning is assessed by the physician in charge and sessions and may be stopped in case of poor tolerance', 'armGroupLabels': ['Awake prone positioning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75020', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Matthieu Turpin, MD', 'role': 'CONTACT', 'email': 'matthieu.turpin@aphp.fr', 'phone': '+33156016574'}, {'name': 'Muriel FARTOUKH, MD, PhD', 'role': 'CONTACT', 'email': 'muriel.fartoukh@aphp.fr', 'phone': '+33156016574'}], 'facility': 'Service de Médecine Intensive Réanimation TENON', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Matthieu Turpin, MD', 'role': 'CONTACT', 'email': 'matthieu.turpin@aphp.fr', 'phone': '+33156016574'}, {'name': 'Muriel Fartoukh, MD, PhD', 'role': 'CONTACT', 'email': 'muriel.fartoukh@aphp.fr', 'phone': '+33156016574'}], 'overallOfficials': [{'name': 'Matthieu Turpin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Muriel Fartoukh, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}, {'name': 'Alexandre Elabbadi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}