Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-02-26 @ 11:36 PM
Study NCT ID:
NCT03968120
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2019-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Lung Protective One-lung Ventilation With Fix and Variable PEEP on Oxygenation and Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-01', 'studyFirstSubmitDate': '2019-05-14', 'studyFirstSubmitQcDate': '2019-05-27', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative oxygenation', 'timeFrame': '1 day', 'description': 'PaO2 \\< 60 mmHg'}], 'secondaryOutcomes': [{'measure': 'Postoperative pulmonary complications', 'timeFrame': '90 days', 'description': 'Infiltrate or atelectasis on chest X-ray, fever, laboratory and physical signs of infection'}, {'measure': 'Postoperative extra-pulmonary complications', 'timeFrame': '90 days', 'description': 'new atrial fibrillation, tachycardia, heart failure, myocardial infarct'}, {'measure': '30 day survival/mortality', 'timeFrame': '30 days', 'description': 'number of death within 30 days after surgery'}, {'measure': '90 day survival/mortality', 'timeFrame': '90 days', 'description': 'number of death within 90 days after surgery'}, {'measure': 'Postoperative oxygenation', 'timeFrame': '90 days', 'description': 'SpO2/FiO2 ratio'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypoxemia', 'Pulmonary Sepsis', 'ARDS, Human', 'Pneumonia']}, 'descriptionModule': {'briefSummary': 'During One-lung ventilation, the use of lower tidal volumes (VT) is helpful to avoid over-distension, provide sufficient oxygenation, but can result in increased atelectasis.\n\nNevertheless, it is not known if, during one-lung ventilation with constant low VT, moderate levels of PEEP combined with lung recruitment maneuvers are superior to variable PEEP for intraoperative oxygenation and protection against PPCs.\n\nAim of the study is to compare a strategy using constant tidal volume with recruitment maneuvers versus variable PEEP with recruitment maneuvers during thoracic surgery in adults.\n\nThe investigators hypothesize that in adult, non-obese patients undergoing thoracic surgery under standardized OLV with variable PEEP and recruitment maneuvers as compared to constant PEEP without recruitment maneuvers prevent PPCs.\n\nPatients will be randomly assigned to one of two groups:\n\nFIX PEEP VOLUME GROUP (Groupfix): mechanical ventilation with constant (6 ml/kgIBW) tidal volume and PEEP of 5 cmH2O with recruitment maneuvers\n\nVARIABLE PEEP GROUP (Groupvar): mechanical ventilation with constant (6 ml/kgIBW) tidal volume with variable PEEP with recruitment maneuvers.', 'detailedDescription': 'Lung separation will be performed by DLT technique. Mechanical ventilation will be applied in volume-controlled mode. During two-lung ventilation, VT will be set at 8 mL/kg predicted body weight. During one-lung ventilation, in GroupFix VT will be decreased to 6 mL/kg PBW with 5 cmH2O PEEP.\n\nIn GroupVar VT mechanical ventilation with constant (6 ml/kgIBW) tidal volume with variable PEEP with recruitment maneuvers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient scheduled for open thoracic or video-assisted thoracoscopic surgery under general anesthesia requiring OLV (no emergency surgery)\n* BMI \\< 35 kg/m2\n* Age ≥ 18 years\n* Expected duration of surgery \\> 60 min\n* Expected duration of anesthesia \\> 90 min\n\nExclusion Criteria:\n\n* COPD GOLD 3+4, lung fibrosis, documented bullae, severe emphysema, pneumothorax\n* uncontrolled asthma\n* NYHA 3+4, CCS 3+4\n* previous thoracic surgery\n* ARDS (Berlin definition)\n* documented pulmonary arterial hypertension \\> 40 mmHg syst\n* documented or suspected neuromuscular disease (thymoma, myasthenia)\n* planned mechanical ventilation after surgery\n* bilateral procedures\n* lung separation with other method than DLT (eg diff. airway, trachestomy)\n* surgery in prone position\n* persistent hemodynamic instability, intractable shock\n* intracranial injury or tumor\n* enrollment in other interventional study or refusal of informed consent\n* pregnancy (excluded by anamnesis and/or laboratory analysis)'}, 'identificationModule': {'nctId': 'NCT03968120', 'briefTitle': 'Effect of Lung Protective One-lung Ventilation With Fix and Variable PEEP on Oxygenation and Outcome', 'organization': {'class': 'OTHER', 'fullName': 'University of Debrecen'}, 'officialTitle': 'Effect of Lung Protective One-lung Ventilation With Fix and Variable Positive End-expiratory Pressure (PEEP) on Oxygenation and Outcome: Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': 'DE RKEB/IKEB 4918-2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group Fix:One-lung ventilation with constant PEEP', 'description': 'Controll group: lung protective one-lung ventilation with fix positive end-expiratory pressure (PEEP)'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group Variable:One-lung ventilation with variable PEEP', 'description': 'Variable group: lung protective one-lung ventilation with variable positive end-expiratory pressure (PEEP)', 'interventionNames': ['Other: Change of ventilatory settings']}], 'interventions': [{'name': 'Change of ventilatory settings', 'type': 'OTHER', 'description': 'Change of Positive End-Exspiratory Pressure during one-lung ventilation', 'armGroupLabels': ['Group Variable:One-lung ventilation with variable PEEP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'University of Debrecen, Department of Anaesthesiology and Intensive Care', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Debrecen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head, Division General, Vascular and Thoracic Anaesthesia', 'investigatorFullName': 'Tamas Vegh, MD', 'investigatorAffiliation': 'University of Debrecen'}}}}