Ignite Creation Date:
2025-12-25 @ 3:15 AM
Ignite Modification Date:
2026-01-01 @ 1:06 AM
Study NCT ID:
NCT04369105
Status:
COMPLETED
Last Update Posted:
2021-09-30
First Post:
2020-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prono Position and Mechanical Power
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016684', 'term': 'Prone Position'}], 'ancestors': [{'id': 'D011187', 'term': 'Posture'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-28', 'studyFirstSubmitDate': '2020-04-24', 'studyFirstSubmitQcDate': '2020-04-29', 'lastUpdatePostDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mechanical power of the respiratory system measured in supine compared with prone position while maintaining the same ventilatory setting', 'timeFrame': '1) Supine position; 2) Prone position, after 15 min', 'description': 'Mechanical power measured in Joules/min'}], 'secondaryOutcomes': [{'measure': 'Mechanical power of the respiratory system measured in supine compared with prone position after adjusting the ventilatory setting', 'timeFrame': '1) Supine position; 2) Prone position, after 15 min of adjusting ventilatory setting.', 'description': 'Mechanical power measured in Joules/min'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ventilation, artificial', 'respiratory distress syndrome, adult', 'prone position', 'monitoring, physiologic'], 'conditions': ['Acute Respiratory Distress Syndrome']}, 'referencesModule': {'references': [{'pmid': '27525106', 'type': 'RESULT', 'citation': 'Marti J, Hall P, Hamilton P, Lamb S, McCabe C, Lall R, Darbyshire J, Young D, Hulme C. One-year resource utilisation, costs and quality of life in patients with acute respiratory distress syndrome (ARDS): secondary analysis of a randomised controlled trial. J Intensive Care. 2016 Aug 11;4:56. doi: 10.1186/s40560-016-0178-8. eCollection 2016.'}, {'pmid': '18270352', 'type': 'RESULT', 'citation': 'Meade MO, Cook DJ, Guyatt GH, Slutsky AS, Arabi YM, Cooper DJ, Davies AR, Hand LE, Zhou Q, Thabane L, Austin P, Lapinsky S, Baxter A, Russell J, Skrobik Y, Ronco JJ, Stewart TE; Lung Open Ventilation Study Investigators. Ventilation strategy using low tidal volumes, recruitment maneuvers, and high positive end-expiratory pressure for acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2008 Feb 13;299(6):637-45. doi: 10.1001/jama.299.6.637.'}, {'pmid': '10793162', 'type': 'RESULT', 'citation': 'Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.'}, {'pmid': '25693014', 'type': 'RESULT', 'citation': 'Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639.'}, {'pmid': '30291378', 'type': 'RESULT', 'citation': 'Serpa Neto A, Deliberato RO, Johnson AEW, Bos LD, Amorim P, Pereira SM, Cazati DC, Cordioli RL, Correa TD, Pollard TJ, Schettino GPP, Timenetsky KT, Celi LA, Pelosi P, Gama de Abreu M, Schultz MJ; PROVE Network Investigators. Mechanical power of ventilation is associated with mortality in critically ill patients: an analysis of patients in two observational cohorts. Intensive Care Med. 2018 Nov;44(11):1914-1922. doi: 10.1007/s00134-018-5375-6. Epub 2018 Oct 5.'}, {'pmid': '27620287', 'type': 'RESULT', 'citation': 'Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M. Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.'}, {'pmid': '23688302', 'type': 'RESULT', 'citation': 'Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to compare the mechanical power applied to the respiratory system in patient with acute respiratory distress syndrome in supine positioning and after the implementation of prone positioning while mantaining the same ventilatory setting.\n\nThe secondary objetive of the study is to compare the mechanical power applied to the respiratory system in patient with acute respiratory distress syndrome in supine positioning and after the implementation of prone positioning and adjusting an individualized ventilatory setting.', 'detailedDescription': 'Data of mechanical power will be collected prospectively in three different times:\n\n1. In supine positioning (T0).\n2. After 15 minutes of having implemented prone positioning while maintaining the same ventilatory settings that in supine (T1).\n3. In prone positioning after 15 min of having adjusted an individualized ventilatory setting (T2).\n\nBesides, the investigators will take an arterial blood sample in T0 and T2 to calculate changes in oxygenation status and ventilatory ratio.\n\nIn case that esophageal manometry is available, the investigators will collect data regarding to transpulmonary and esophageal pressure in order to calculate the mechanical power applied to the lung parenchyma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients included will be those who atend to the intensive care unit of medical centers located in Buenos Aires province, Argetina.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged older than 18 years old under invasive mechanical ventilation with diagnostic criteria of acute respiratory distress syndrome acording to berlin definition and neccesity of prone positioning.\n\nExclusion Criteria:\n\n* Need to interrump prone positioning maneuver.\n* Inability to collect data for any reason.'}, 'identificationModule': {'nctId': 'NCT04369105', 'acronym': 'PROMP', 'briefTitle': 'Prono Position and Mechanical Power', 'organization': {'class': 'OTHER', 'fullName': 'Sanatorio Anchorena San Martin'}, 'officialTitle': 'Influence of the Prone Position on Mechanical Power Applied to Respiratory System: Multi-centric Descriptive Study', 'orgStudyIdInfo': {'id': '11/2020'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Prone position', 'type': 'OTHER', 'description': 'The patients will be put in prone position while receiving invasive mechanical ventilation and the investigators will monitor changes in mechanical power applied to the respiratory system and compare with supine position'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B1650CQU', 'city': 'San MartÃn', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Sanatorio Anchorena de San Martin', 'geoPoint': {'lat': -35.02575, 'lon': -57.75317}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanatorio Anchorena San Martin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of respiratory therapists', 'investigatorFullName': 'Matias Accoce', 'investigatorAffiliation': 'Sanatorio Anchorena San Martin'}}}}