Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-26 @ 11:12 PM
Study NCT ID:
NCT02039466
Status:
UNKNOWN
Last Update Posted:
2014-07-11
First Post:
2014-01-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Pressure-controlled Ventilation on the Respiratory Complication in Patients Undergoing Laparoscopic Colectomy Compared With Volume-controlled Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-07-10', 'studyFirstSubmitDate': '2014-01-16', 'studyFirstSubmitQcDate': '2014-01-16', 'lastUpdatePostDateStruct': {'date': '2014-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'peak airway pressure in patients receiving pressure controlled ventilation and volume controlled ventilation', 'timeFrame': '40 minutes after pneumoperitoneum'}]}, 'conditionsModule': {'conditions': ['Postoperative Respiratory Complication']}, 'descriptionModule': {'briefSummary': 'Postoperative pulmonary complications following abdominal surgery are frequent and associated with increased morbidity and mortality and hospital length of stay. Pressure controlled ventilation will improve oxygenation indices , hemodynamics during anesthesia for laparoscopic colectomy, decreasing postoperative pulmonary complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status classification\n* patients scheduled for laparoscopic colectomy\n\nExclusion Criteria:\n\n* severe cardiopulmonary disease\n* patients who cannot understand Korean'}, 'identificationModule': {'nctId': 'NCT02039466', 'briefTitle': 'The Effect of Pressure-controlled Ventilation on the Respiratory Complication in Patients Undergoing Laparoscopic Colectomy Compared With Volume-controlled Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine'}, 'orgStudyIdInfo': {'id': 'ChungAng UH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'volume controlled ventilation', 'description': 'volume controlled ventilation as a tidal volume of 8 ml/kg (ideal body weight)', 'interventionNames': ['Procedure: volume controlled ventilation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'pressure controlled ventilation', 'description': 'pressure controlled ventilation as a tidal volume of 8 ml/kg (ideal body weight)', 'interventionNames': ['Procedure: pressure controlled ventilation']}], 'interventions': [{'name': 'volume controlled ventilation', 'type': 'PROCEDURE', 'armGroupLabels': ['volume controlled ventilation']}, {'name': 'pressure controlled ventilation', 'type': 'PROCEDURE', 'armGroupLabels': ['pressure controlled ventilation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '156-755', 'city': 'Seoul', 'state': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seong Deok Kim, MD.PhD', 'role': 'CONTACT', 'email': 'ksddeok@cau.ac.kr', 'phone': '82-2-6299-2571'}, {'name': 'Soyoung Yang, MD.PhD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chung-Ang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Soyoung Yang, clinical assistant professor', 'role': 'CONTACT', 'email': 'didth79@hanmail.net', 'phone': '82-2-6299-3160'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'So Young Yang. MD.PHD', 'investigatorFullName': 'So Young Yang', 'investigatorAffiliation': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine'}}}}