Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-01-04 @ 10:23 AM
Study NCT ID:
NCT02816359
Status:
COMPLETED
Last Update Posted:
2025-09-11
First Post:
2016-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Position and Esophageal Pressure
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2016-06-24', 'studyFirstSubmitQcDate': '2016-06-24', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total End-expiratory esophageal pressure', 'timeFrame': '30min after change of position', 'description': 'After end-expiratory pause on the ventilator, absolute value of the esophageal pressure is measured (in Head-bed position at 30° then in head-bed position at 0° )'}], 'secondaryOutcomes': [{'measure': 'End-inspiratory esophageal pressure', 'timeFrame': '30min after change of position', 'description': 'After end-inspiratory pause on the ventilator, absolute value of the esophageal pressure is measured (in Head-bed position at 30° then in head-bed position at 0° )'}, {'measure': 'Gastric pressure', 'timeFrame': '30min after change of position', 'description': 'After end-expiratory pause and end-inspiratory pause on the ventilator, absolute value of the gastric pressure is measured (in Head-bed position at 30° then in head-bed position at 0° )'}, {'measure': 'End-expiratory lung volume', 'timeFrame': '30min after change of position', 'description': 'End-expiratory lung volume is measured with nitrogen wash-in wash-out method, available in the ventilator (in Head-bed position at 30° then in head-bed position at 0° )'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Position patient', 'Esophageal pressure'], 'conditions': ['Acute Respiratory Distress Syndrome']}, 'referencesModule': {'references': [{'pmid': '30535985', 'type': 'RESULT', 'citation': 'Mezidi M, Guerin C. Effect of body position and inclination in supine and prone position on respiratory mechanics in acute respiratory distress syndrome. Intensive Care Med. 2019 Feb;45(2):292-294. doi: 10.1007/s00134-018-5493-1. Epub 2018 Dec 7. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Esophageal pressure measurements are used in moderate/severe Accurate Respiratory Distress SyndromeARDS patients in order to set ventilator settings. There might be variations of the measured value according to the patient position (0° vs 30°) at the time of measurements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Acute respiratory failure defined by PaO2/FIO2\\< 300 mmHg or pH\\<7,35 and pCO2\\>45mmHg or Moderate or severe Accurate Respiratory Distress Syndrome ARDS defined by:\n\n * New or worsening respiratory symptoms in the previous week.\n * Bilateral opacities-not fully explained by effusions, lobar/lung collapse, or Nodules\n * Respiratory failure not fully explained by cardiac failure or fluid overload\n * PaO2/FIO2\\< 200 mmHg and PEEP ≥ 5 cm H2O and VT ≤6 ml/kg of Ideal Body Weight\n* Patient intubated or tracheotomized and receiving mechanical ventilation\n* Indication of esophageal measurement decided by the clinician\n\nExclusion Criteria:\n\n* Contraindication to naso-gastric tube insertion :\n\n * Recent gastro-duodenal ulcer\n * Stage III esophageal varices\n* Refractory intracranial hypertension\n* Unstabilized spine fracture\n* Surgical contraindication\n* Burns on more than 20 % of the body surface\n* Underlying disease with a life expectancy of less than one year\n* End-of-life decision before inclusion\n* Pregnant or breast-feeding patients\n* Subject deprived of freedom, minor, subject under a legal protective measure\n* Research team unavailability\n* Lack of medical care plan'}, 'identificationModule': {'nctId': 'NCT02816359', 'acronym': 'pEsition', 'briefTitle': 'Position and Esophageal Pressure', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Impact of Patient Position on the Value of Esophageal Pressure. pEsition Study.', 'orgStudyIdInfo': {'id': '69HCL16_0152'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'head-bed position', 'description': 'Head-bed position at 0° for 30 minutes then head-bed position at 30° for 30 minutes', 'interventionNames': ['Other: head-bed position']}], 'interventions': [{'name': 'head-bed position', 'type': 'OTHER', 'description': 'Head-bed position at 0° for 30 minutes then head-bed position at 30° for 30 minutes', 'armGroupLabels': ['head-bed position']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69004', 'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital Croix-Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Claude Guerin, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}