Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-29 @ 4:57 PM
Study NCT ID:
NCT03083457
Status:
COMPLETED
Last Update Posted:
2021-01-29
First Post:
2017-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physiological Effects of Lung Recruitment During General Anesthesia and Low-tidal Volume Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018681', 'term': 'Anesthetics, General'}, {'id': 'D055103', 'term': 'Hypodermoclysis'}], 'ancestors': [{'id': 'D000777', 'term': 'Anesthetics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D055104', 'term': 'Infusions, Subcutaneous'}, {'id': 'D007263', 'term': 'Infusions, Parenteral'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005440', 'term': 'Fluid Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Each patient will be randomized to receive or not scheduled recruiting maneuvers every hour. In each of the two groups, patients will receive mechanical ventilation with 3 different levels of PEEP in a sequential, randomized, cross-over manner: each period will last 40 minutes.\n\nA randomization sequence will be produced by a dedicated software and sealed envelopes will be used to allocate patients to study treatments.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-28', 'studyFirstSubmitDate': '2017-03-14', 'studyFirstSubmitQcDate': '2017-03-14', 'lastUpdatePostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Driving Pressure', 'timeFrame': 'At the end of each 40-minute step', 'description': 'Respiratory system elastic pressure (Plateau pressure-total PEEP)'}], 'secondaryOutcomes': [{'measure': 'Lung strain', 'timeFrame': 'At the end of each 40-minute step', 'description': 'Lung static and dynamic strain'}, {'measure': 'Dead space', 'timeFrame': 'At the end of each 40-minute step', 'description': 'Approximated as the difference between End-tidal CO2 and PaCO2 divided by PaCO2'}, {'measure': 'Oxygenation', 'timeFrame': 'At the end of each 40-minute step', 'description': 'PaO2/FiO2'}, {'measure': 'Lung recruitment', 'timeFrame': 'At the end of each 40-minute step', 'description': '% (lung recruitment/change in end-expiratory lung volume)'}, {'measure': 'Lung overdistension due to PEEP', 'timeFrame': 'At the end of each 40-minute step', 'description': '% (lung overdistension/change in end-expiratory lung volume)'}, {'measure': 'Functional residual capacity', 'timeFrame': 'At the end of each 40-minute step', 'description': 'Change in functional residual capacity due to PEEP, measured with the Nitrogen washin-washout technique'}, {'measure': 'Heart rate', 'timeFrame': 'At the end of each 40-minute step', 'description': 'heart rate'}, {'measure': 'Blood pressure', 'timeFrame': 'At the end of each 40-minute step', 'description': 'Arterial blood pressure'}, {'measure': 'Stroke volume', 'timeFrame': 'At the end of each 40-minute step', 'description': 'Stroke volume, measured by pulse contour analysis'}, {'measure': 'Stroke volume variation', 'timeFrame': 'At the end of each 40-minute step', 'description': 'Stroke volume variation, measured by pulse contour analysis'}, {'measure': 'Cardiac Output', 'timeFrame': 'At the end of each 40-minute step', 'description': 'Stroke volume x heart rate'}, {'measure': 'Fluid requirements', 'timeFrame': 'At the end of each 40-minute step', 'description': 'Fluid bolus requirements, according to the decision of the attending physician blinded to the design of the study'}, {'measure': 'Vasoactive agents', 'timeFrame': 'At the end of each 40-minute step', 'description': 'Vasoactive agents requirements, according to the decision of the attending physician blinded to the design of the study'}, {'measure': 'Adverse events', 'timeFrame': 'At the end of each 40-minute step', 'description': 'Adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia, General', 'Surgery']}, 'descriptionModule': {'briefSummary': 'Low-tidal volume ventilation is arising as a tool to optimize the ventilatory management and to improve clinical outcome in patients undergoing general anesthesia for abdominal surgery.\n\nA recent large randomized controlled trial failed to detect a significant difference between two different approaches for ensuring adequate lung recruitment (PEEP=12 cmH2O + scheduled recruiting maneuvers vs. PEEP 2 cmH2O) during protective ventilation. Thus, in patients undergoing open abdominal surgery and receiving low-tidal volumes, the effects of different positive end-expiratory pressure (PEEP) levels and recruiting maneuvers remain to be established.\n\nDesign: prospective, cross-over, physiological trial.\n\nPURPOSE To assess the physiological effects of different PEEP levels with or without scheduled recruiting maneuvers in patients undergoing general anesthesia for open abdominal surgery and receiving low-tidal volume ventilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA physical status I-II patients\n* scheduled for open abdominal surgery (major gastrointestinal surgery: duodeno-cephalo-pancreatectomy, gastrectomy, hemi-colectomy; gynecological surgery; oncologic surgery)\n* Expected duration of surgery \\>= 150 minutes\n\nExclusion Criteria:\n\n* Pregnancy\n* BMI\\>30 kg/m\\^2\n* hepatic surgery\n* Cardiac failure NYHA\\>2\n* History of chronic respiratory failure'}, 'identificationModule': {'nctId': 'NCT03083457', 'acronym': 'PEEP-RM', 'briefTitle': 'Physiological Effects of Lung Recruitment During General Anesthesia and Low-tidal Volume Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Catholic University of the Sacred Heart'}, 'officialTitle': 'Physiological Effects of Positive End-expiratory Pressure With or Without Recruiting Maneuvers in Patients Receiving Low-tidal Volume Ventilation During General Anesthesia for Open Abdominal Surgery. A Randomized, Cross-over Study', 'orgStudyIdInfo': {'id': '10989/15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEEP2 + RM', 'description': 'General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=2 cmH2O and scheduled recruiting maneuvers at the beginning of each PEEP step, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study', 'interventionNames': ['Drug: Fluid resuscitation or amine administration', 'Drug: General anesthetic', 'Drug: Fluid administration', 'Procedure: Low-tidal volume ventilation', 'Procedure: Scheduled recruiting maneuvers']}, {'type': 'EXPERIMENTAL', 'label': 'PEEP7 + RM', 'description': 'General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=7 cmH2O and scheduled recruiting maneuvers at the beginning of the PEEP step, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study', 'interventionNames': ['Drug: Fluid resuscitation or amine administration', 'Drug: General anesthetic', 'Drug: Fluid administration', 'Procedure: Low-tidal volume ventilation', 'Procedure: Scheduled recruiting maneuvers']}, {'type': 'EXPERIMENTAL', 'label': 'PEEP12 + RM', 'description': 'General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=12 cmH2O and scheduled recruiting maneuvers at the beginning of the PEEP step, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study', 'interventionNames': ['Drug: Fluid resuscitation or amine administration', 'Drug: General anesthetic', 'Drug: Fluid administration', 'Procedure: Low-tidal volume ventilation', 'Procedure: Scheduled recruiting maneuvers']}, {'type': 'EXPERIMENTAL', 'label': 'PEEP2 - RM', 'description': 'General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=2 cmH2O, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study', 'interventionNames': ['Drug: Fluid resuscitation or amine administration', 'Drug: General anesthetic', 'Drug: Fluid administration', 'Procedure: Low-tidal volume ventilation']}, {'type': 'EXPERIMENTAL', 'label': 'PEEP7 - RM', 'description': 'General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=7 cmH2O, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study', 'interventionNames': ['Drug: Fluid resuscitation or amine administration', 'Drug: General anesthetic', 'Drug: Fluid administration', 'Procedure: Low-tidal volume ventilation']}, {'type': 'EXPERIMENTAL', 'label': 'PEEP12 - RM.', 'description': 'General anesthetic, 40 minutes of Low-tidal volume ventilation with PEEP=12 cmH2O, continuous fluid administration at a standard dose, fluid resuscitation or amine administration if deemed necessary by the attending physician blinded to the design of the study', 'interventionNames': ['Drug: Fluid resuscitation or amine administration', 'Drug: General anesthetic', 'Drug: Fluid administration', 'Procedure: Low-tidal volume ventilation']}], 'interventions': [{'name': 'Fluid resuscitation or amine administration', 'type': 'DRUG', 'description': 'Fluid administration or amine administration if deemed necessary by the attending physician. Haemodynamics will be monitored through noninvasive cardiac output assessment by arterial pulse contour analysis', 'armGroupLabels': ['PEEP12 + RM', 'PEEP12 - RM.', 'PEEP2 + RM', 'PEEP2 - RM', 'PEEP7 + RM', 'PEEP7 - RM']}, {'name': 'General anesthetic', 'type': 'DRUG', 'description': 'Total intravenous anesthesia with a standard protocol', 'armGroupLabels': ['PEEP12 + RM', 'PEEP12 - RM.', 'PEEP2 + RM', 'PEEP2 - RM', 'PEEP7 + RM', 'PEEP7 - RM']}, {'name': 'Fluid administration', 'type': 'DRUG', 'description': '3-5 ml/kg of balanced crystalloids will be administered throughout the whole surgical procedure', 'armGroupLabels': ['PEEP12 + RM', 'PEEP12 - RM.', 'PEEP2 + RM', 'PEEP2 - RM', 'PEEP7 + RM', 'PEEP7 - RM']}, {'name': 'Low-tidal volume ventilation', 'type': 'PROCEDURE', 'description': 'Volume-control ventilation with tidal volume=7 ml/kg of predicted body weight for the entire surgical procedure. Respiratory rate will be set to maintain EtCO2 within a physiological range and kept unchanged for the entire duration of the study', 'armGroupLabels': ['PEEP12 + RM', 'PEEP12 - RM.', 'PEEP2 + RM', 'PEEP2 - RM', 'PEEP7 + RM', 'PEEP7 - RM']}, {'name': 'Scheduled recruiting maneuvers', 'type': 'PROCEDURE', 'description': 'Pressure-control ventilation inspiratory pressure=10 cmH2O. Steplike 5-cmH2O-PEEP increase every 30 seconds to achieve a peep of 35 cmH2O, followed by 5-cmH2O-PEEP reduction every 30 seconds to set PEEP', 'armGroupLabels': ['PEEP12 + RM', 'PEEP2 + RM', 'PEEP7 + RM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00100', 'city': 'Rome', 'country': 'Italy', 'facility': 'General surgery OR, A. Gemelli hospital', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Massimo Antonelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Catholic University of the Sacred Heart'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catholic University of the Sacred Heart', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Massimo Antonelli', 'investigatorAffiliation': 'Catholic University of the Sacred Heart'}}}}