Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-25 @ 9:40 PM
Study NCT ID:
NCT01457651
Status:
COMPLETED
Last Update Posted:
2013-06-25
First Post:
2011-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Four Different Recruitment Maneuvers in Patients After Coronary Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-24', 'studyFirstSubmitDate': '2011-10-20', 'studyFirstSubmitQcDate': '2011-10-21', 'lastUpdatePostDateStruct': {'date': '2013-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory support', 'timeFrame': '24 hrs', 'description': 'The duration of the postoperative respiratory support'}], 'secondaryOutcomes': [{'measure': 'The incidence of postoperative atelectasis', 'timeFrame': '24 hrs', 'description': 'Incidence of atelectases during 24 hrs'}, {'measure': 'Incidence of reintubation', 'timeFrame': '24 Hrs'}, {'measure': 'Oxygenation', 'timeFrame': '12 hrs after extubation', 'description': 'Changes in PaO2/FiO2 ratio'}, {'measure': 'Length of ICU and hospital stay', 'timeFrame': '28 Days', 'description': 'Length of ICU and hospital stay'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Recruitment', 'Coronary artery bypass grafting', 'Postoperative period'], 'conditions': ['Hypoxemia', 'Recruitment']}, 'descriptionModule': {'briefSummary': 'The risk of respiratory failure after cardiac surgery is high, and it may result in many complications. The maneuver of alveolar recruitment may improve the oxygen transport in the human organism. The investigators compare three different types of alveolar recruitment in patient after cardiac surgery, to reveal which one is better.', 'detailedDescription': 'The study compares three different approaches to alveolar recruitment maneuvers in the immediate postoperative period after off-pump coronary bypass grafting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 75\n* Off-pump coronary artery bypass grafting\n* Possibility to discontinue respiratory support in the first day after intervention\n\nExclusion Criteria:\n\n* Signs of ARDS\n* COPD in decompensation phase\n* Requirement for inotropic support(epinephrine \\>0,1 mcg/kg/hr)\n* Bronchiectases\n* Pregnancy\n* Morbid obesity\n* Aortic aneurism\n* AMI in previous month'}, 'identificationModule': {'nctId': 'NCT01457651', 'acronym': 'RECR-CABG', 'briefTitle': 'Comparison of Four Different Recruitment Maneuvers in Patients After Coronary Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Northern State Medical University'}, 'officialTitle': 'Comparison of Different Types of Postoperative Pulmonary Recruitment and Predicting Its Efficacy Following Off-pump Coronary Artery Bypass Grafting', 'orgStudyIdInfo': {'id': 'RECR-CABG-2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Recruitment 40x40', 'description': 'The group where recruitment is performed by increase in airway pressure up to 40 cm H2O for 40 seconds', 'interventionNames': ['Procedure: Alveolar recruitment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Recruitment PEAK40', 'description': 'Increase in peak airway pressure up to 40 cm H2O during tidal ventilation', 'interventionNames': ['Procedure: Alveolar recruitment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Recruitment 15x300', 'description': 'Recruitment by increase in airway PEEP up to 15 cm H2O for 300 sec', 'interventionNames': ['Procedure: Alveolar recruitment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No recruitment', 'description': 'No recruitment is performed: standard respiratory support.', 'interventionNames': ['Procedure: Alveolar recruitment']}], 'interventions': [{'name': 'Alveolar recruitment', 'type': 'PROCEDURE', 'otherNames': ['CPAP40', 'PEAK40', 'PEEP15', 'CONTROLS'], 'description': 'Four approaches:\n\n1. CPAP 40 cm H2O\n2. Peak pressure 40 cm H2O\n3. PEEP 15 cm H2O for 300 sec\n4. no intervention (controls)', 'armGroupLabels': ['No recruitment', 'Recruitment 15x300', 'Recruitment 40x40', 'Recruitment PEAK40']}]}, 'contactsLocationsModule': {'locations': [{'zip': '163000', 'city': 'Arkhangelsk', 'state': 'Arkhangelskaya oblast', 'country': 'Russia', 'facility': 'City hospital # 1', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}], 'overallOfficials': [{'name': 'Mikhail Y. Kirov, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Northern State Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northern State Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Regional hospital of Arkhangelsk', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, MD, PhD', 'investigatorFullName': 'Vsevolod V. Kuzkov', 'investigatorAffiliation': 'Northern State Medical University'}}}}