Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT04543760
Status:
COMPLETED
Last Update Posted:
2022-03-22
First Post:
2020-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Prone Positioning Combined With High Flow Oxygen Therapy on Oxygenation During Acute Respiratory Failure Due to COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016684', 'term': 'Prone Position'}, {'id': 'D016683', 'term': 'Supine Position'}], 'ancestors': [{'id': 'D011187', 'term': 'Posture'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-07', 'studyFirstSubmitDate': '2020-09-08', 'studyFirstSubmitQcDate': '2020-09-09', 'lastUpdatePostDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '[PaO2 / FiO2] ratio', 'timeFrame': '6 hours', 'description': 'Oxygenation will be evaluated by the \\[PaO2 / FiO2\\] ratio, measured at the beginning (baseline) and at the end of each 2h-sequence by arterial gasometry. The values of this ratio in PP and SP will be compared with each other.'}], 'secondaryOutcomes': [{'measure': 'ΔPeso measured using an esophageal balloon catheter', 'timeFrame': '6 hours', 'description': 'ΔPeso (cm H2O): defined at each inspiratory cycle as the difference between the esophageal pressure at the end of expiration and at the end of inspiration.'}, {'measure': 'Concentration of CO2 at the end of expiration (EtCO2, mmHg)', 'timeFrame': '6 hours', 'description': 'Capnometry measurements by breathing on a mouthpiece connected to an online analyzer.\n\nThe measurements will be made on a 2 min recording (analysis of the curves over a period of 1 min) at the end of each sequence (PP or SP) and compared with each other.'}, {'measure': 'Intensity of dyspnea', 'timeFrame': '6 hours', 'description': 'assessed by the visual analogue scale for dyspnea (collected at the beginning and at the end of each 2h sequence; the values at the end of each sequence will be compared with each other): 0 = no breathlessness to 10 = worst breathlessness possible'}, {'measure': 'Tolerance of the technique', 'timeFrame': '6 hours', 'description': 'measured by the visual analogue scale for pain (collected at the beginning and at the end of each 2h-sequence; the values at the end of each sequence will be compared with each other): 0 = no pain to 10 = worst pain possible'}, {'measure': 'Tolerance of the technique', 'timeFrame': '6 hours', 'description': 'measured by the visual analogue scale for discomfort (collected at the beginning and at the end of each 2h-sequence; the values at the end of each sequence will be compared with each other): 0 = no discomfort to 10 = worst discomfort possible'}, {'measure': 'The occurrence of side effects due to PP', 'timeFrame': '6 hours', 'description': 'Oxygen desaturation (SaO2 \\<90%), occurrence of hemodynamic instability (Systolic blood pressure \\<80 mmHg or heart rate \\>120 mmHg for \\>1 minute), accidental withdrawal of venous catheter central or peripheral, accidental withdrawal of arterial catheter, accidental withdrawal of urinary catheter.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality.\n\nProne positioning (PP) is a recommended strategy for patients with moderate to severe acute respiratory distress syndrome (ARDS) undergoing invasive mechanical ventilation.\n\nEarly PP combined with High Flow Oxygen Therapy may benefit spontaneous breathing patients with AHRF due to COVID-19 as recently reported in Jiangsu.\n\nOur hypothesis is that early PP combined with High Flow Oxygen Therapy in patients with AHRF due to COVID-19 improves oxygenation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥ 18 years,\n* Admitted to ICU within 72 hours,\n* Having confirmed or highly suspected COVID-19 infection (positive RT-PCR and/or computed tomography),\n* Having acute hypoxemic respiratory failure with a \\[PaO2/FiO2\\] ratio between 100 mmHg and 300 mmHg,\n* Having given free and informed written consent,\n* Being affiliated with or benefiting from a social security scheme.\n\nExclusion Criteria:\n\n* Unable to achieve a prone position for mobility reasons,\n* Unable to achieve a prone position due to agitation whatever the cause,\n* With clinical occlusive syndrome in order to limit the risk of inhalation,\n* Having a contraindication to the use of the esophageal catheter,\n* Having signs of respiratory distress or disturbance of consciousness requiring intubation within the next hours,\n* Having hypercapnia indicating the use of non-invasive ventilation (PaO2\\> 50 mmHg),\n* Having severe hypoxemia defined by PaO2 / FiO2 \\<100mmHg,\n* Ongoing pregnancy or breastfeeding,\n* Subject to a measure for the protection of justice.'}, 'identificationModule': {'nctId': 'NCT04543760', 'acronym': 'DeCOPO', 'briefTitle': 'Effect of Prone Positioning Combined With High Flow Oxygen Therapy on Oxygenation During Acute Respiratory Failure Due to COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Hospital St. Joseph, Marseille, France'}, 'officialTitle': 'Effect of Prone Positioning Combined With High Flow Oxygen Therapy on Oxygenation During Acute Respiratory Failure Due to Sars-covid-2: a Randomized Crossover Trial.', 'orgStudyIdInfo': {'id': '2020-04-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '[PP sequence 1] - Wash-out - [SP sequence 2]', 'interventionNames': ['Other: Prone position', 'Other: Supine position']}, {'type': 'OTHER', 'label': '[SP sequence 1] - Wash-out - [PP sequence 2]', 'interventionNames': ['Other: Prone position', 'Other: Supine position']}], 'interventions': [{'name': 'Prone position', 'type': 'OTHER', 'description': 'prone positioning in spontaneous ventilation', 'armGroupLabels': ['[PP sequence 1] - Wash-out - [SP sequence 2]', '[SP sequence 1] - Wash-out - [PP sequence 2]']}, {'name': 'Supine position', 'type': 'OTHER', 'description': 'supine positiong in spontaneous ventilation', 'armGroupLabels': ['[PP sequence 1] - Wash-out - [SP sequence 2]', '[SP sequence 1] - Wash-out - [PP sequence 2]']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13003', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital Européen', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13005', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital La Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13008', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital Saint Joseph', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13915', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'Samuel LEHINGUE, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital Saint Joseph Marseille'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'beginning 3 months and ending 2 years following article publication', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in the published article, after deidentification (text, tables, figures, and appendices).', 'accessCriteria': 'The data will be shared with investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.\n\nThe proposal should be directed to the PI, Dr Lehingue.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital St. Joseph, Marseille, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}