Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2026-02-28 @ 6:26 PM
Study NCT ID:
NCT02798133
Status:
COMPLETED
Last Update Posted:
2017-04-26
First Post:
2016-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Lung Approach Versus Standard Protective Strategies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001261', 'term': 'Pulmonary Atelectasis'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-25', 'studyFirstSubmitDate': '2016-06-05', 'studyFirstSubmitQcDate': '2016-06-08', 'lastUpdatePostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'driving pressure', 'timeFrame': 'intraoperative', 'description': 'The driving pressure is a physiological ventilatory parameter measured as platteau pressure minus PEEP. This parameter may be associated with postoperative pulmonary complications'}], 'secondaryOutcomes': [{'measure': 'ventilatory efficiency', 'timeFrame': 'intraoperative', 'description': 'Ventilatory efficiency measured with volumetric capnography which includes dead space and tidal elimination of carbon dioxide.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lung Collapse']}, 'referencesModule': {'references': [{'pmid': '26947624', 'type': 'BACKGROUND', 'citation': 'Neto AS, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Gajic O, El-Tahan MR, Ghamdi AA, Gunay E, Jaber S, Kokulu S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Ranieri VM, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Amato MB, Costa EL, de Abreu MG, Pelosi P, Schultz MJ; PROVE Network Investigators. Association between driving pressure and development of postoperative pulmonary complications in patients undergoing mechanical ventilation for general anaesthesia: a meta-analysis of individual patient data. Lancet Respir Med. 2016 Apr;4(4):272-80. doi: 10.1016/S2213-2600(16)00057-6. Epub 2016 Mar 4.'}, {'pmid': '26672923', 'type': 'BACKGROUND', 'citation': 'Kacmarek RM, Villar J, Sulemanji D, Montiel R, Ferrando C, Blanco J, Koh Y, Soler JA, Martinez D, Hernandez M, Tucci M, Borges JB, Lubillo S, Santos A, Araujo JB, Amato MB, Suarez-Sipmann F; Open Lung Approach Network. Open Lung Approach for the Acute Respiratory Distress Syndrome: A Pilot, Randomized Controlled Trial. Crit Care Med. 2016 Jan;44(1):32-42. doi: 10.1097/CCM.0000000000001383.'}, {'pmid': '24557111', 'type': 'BACKGROUND', 'citation': 'Ferrando C, Mugarra A, Gutierrez A, Carbonell JA, Garcia M, Soro M, Tusman G, Belda FJ. Setting individualized positive end-expiratory pressure level with a positive end-expiratory pressure decrement trial after a recruitment maneuver improves oxygenation and lung mechanics during one-lung ventilation. Anesth Analg. 2014 Mar;118(3):657-65. doi: 10.1213/ANE.0000000000000105.'}, {'pmid': '28493943', 'type': 'DERIVED', 'citation': 'Ferrando C, Suarez-Sipmann F, Tusman G, Leon I, Romero E, Gracia E, Mugarra A, Arocas B, Pozo N, Soro M, Belda FJ. Open lung approach versus standard protective strategies: Effects on driving pressure and ventilatory efficiency during anesthesia - A pilot, randomized controlled trial. PLoS One. 2017 May 11;12(5):e0177399. doi: 10.1371/journal.pone.0177399. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to compare the effects of adding a recruitment maneuver (RM) to low tidal volume (VT) ventilation, with or without an individualized post-RM positive end-expiratory pressure (PEEP) setting in lung-healthy patients during anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA physical status I-III undergoing elective major abdominal surgery including pancreatic-duodenectomy, gastrectomy and liver resection\n\nExclusion Criteria:\n\n* i) laparoscopic surgery, ii) patients with previous respiratory disease.'}, 'identificationModule': {'nctId': 'NCT02798133', 'briefTitle': 'Open Lung Approach Versus Standard Protective Strategies', 'organization': {'class': 'OTHER', 'fullName': 'Fundación para la Investigación del Hospital Clínico de Valencia'}, 'officialTitle': 'Open Lung Approach Versus Standard Protective Strategies: Effects on Driving Pressure and Ventilatory Efficiency During Anesthesia', 'orgStudyIdInfo': {'id': 'OLA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OLA', 'description': 'recruitment maneuver + individualized PEEP', 'interventionNames': ['Procedure: OLA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RM-5', 'description': 'recruitment maneuver + fixed standard PEEP', 'interventionNames': ['Procedure: RM-5']}], 'interventions': [{'name': 'OLA', 'type': 'PROCEDURE', 'description': 'PEEP titration trial for best Cdyn after the alveolar recruitment maneuver', 'armGroupLabels': ['OLA']}, {'name': 'RM-5', 'type': 'PROCEDURE', 'description': 'Fixed standard PEEP after the alveolar recruitment maneuver', 'armGroupLabels': ['RM-5']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación para la Investigación del Hospital Clínico de Valencia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Carlos Ferrando', 'investigatorAffiliation': 'Fundación para la Investigación del Hospital Clínico de Valencia'}}}}