Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT04632602
Status:
COMPLETED
Last Update Posted:
2021-08-13
First Post:
2020-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Awake Prone Position to Reduce Ventilation Inhomogeneity in COVID-19 Acute Respiratory Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Each patient will be his own control. The order of the experimental periods will be:\n\n1. arm A: prone position followed by dorsal decubitus\n2. arm B: dorsal decubitus followed by ventral decubitus A 30-minute wash-out period is set between the end of sequence 1 and the start of sequence 2.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-12', 'studyFirstSubmitDate': '2020-11-16', 'studyFirstSubmitQcDate': '2020-11-16', 'lastUpdatePostDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global Inhomogeneity Index variations (expressed in percentage) between baseline, supine and prone position periods.', 'timeFrame': '2hours', 'description': 'Electrical Impedance Tomography (EIT)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'Evaluation of awake prone position on ventilation inhomogeneity in COVID-19 associated respiratory failure.', 'detailedDescription': 'Awake prone position has been proposed as an additional treatment to alleviate hypoxemia during COVID-19 acute respiratory failure and potentially to avoid in some case tracheal intubation and invasive ventilation. Potential mechanism is improvement of ventilation: perfusion mismatch through redistribution of ventilation to the dorsal part of the lungs where perfusion is prominent. Electrical impedance tomography (EIT) is a non-invasive functional lung imaging of distribution of ventilation. Therefore, we aim to assess EIT on lung ventilation inhomogeneity during supine and prone position in COVID-19 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* more than 18 Years (Adult, Older Adult)\n* Confirmed COVID-19 (positive SARS-CoV-2 RT-PCR at nasopharyngeal swab)\n* Acute respiratory failure with 100 \\< PaO2:FiO2\\< 300 mmhg\n* Spontaneous ventilation with standard oxygen supply or high flow humidified oxygen\n* Written informed consent of the patient\n\nExclusion Criteria:\n\n* Contra-indication to prone position including pregnancy\n* Presence of pacemaker\n* Severe hypoxemia with PaO2/FiO2 \\< 100 mmHg\n* Evidence of clinical signs of respiratory distress with high probability of intubation in the next two hours'}, 'identificationModule': {'nctId': 'NCT04632602', 'acronym': 'ProneSpontCov', 'briefTitle': 'Awake Prone Position to Reduce Ventilation Inhomogeneity in COVID-19 Acute Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Awake Prone Position to Reduce Ventilation Inhomogeneity in COVID-19 Acute Respiratory Failure: a Randomized Cross Over Electrical Impedance Tomography Study', 'orgStudyIdInfo': {'id': '2020-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'patients in prone position followed by dorsal decubitus', 'description': 'patients will be randomized on the order of position, either supine then prone, either prone then supine. Each period will last at least 2 hours.', 'interventionNames': ['Other: physiological effects of awake prone position in COVID 19 patients']}, {'type': 'OTHER', 'label': 'dorsal decubitus followed by prone decubitus', 'description': 'patients will be randomized on the order of position, either supine then prone, either prone then supine. Each period will last at least 2 hours.', 'interventionNames': ['Other: physiological effects of awake prone position in COVID 19 patients']}], 'interventions': [{'name': 'physiological effects of awake prone position in COVID 19 patients', 'type': 'OTHER', 'description': 'Study of physiological effects of awake prone position in COVID 19 patients on lung inhomogeneity assessed by Electrical Impedance Tomography (EIT), gas exchange and dyspnea score (Borg Scale).\n\nMeasurements will be performed at baseline (on supine position), then patients will be randomized on the order of position, either supine then prone, either prone then supine. Each period will last at least 2 hours. EIT records will be performed during the last 30 minutes of each period, blood gas and dyspnea score at the end of each period.', 'armGroupLabels': ['dorsal decubitus followed by prone decubitus', 'patients in prone position followed by dorsal decubitus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13354', 'city': 'Marseille', 'country': 'France', 'facility': 'Assistance Publique Höpitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'Jean-Olivier ARNAUD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}