Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2025-12-25 @ 12:54 PM
Study NCT ID:
NCT01194895
Status:
COMPLETED
Last Update Posted:
2013-03-14
First Post:
2010-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Trial to Evaluate the Impact of Lung-protective Intervention in Patients Undergoing Esophageal Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055371', 'term': 'Acute Lung Injury'}], 'ancestors': [{'id': 'D055370', 'term': 'Lung Injury'}, {'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': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-13', 'studyFirstSubmitDate': '2010-08-18', 'studyFirstSubmitQcDate': '2010-09-02', 'lastUpdatePostDateStruct': {'date': '2013-03-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cytokines of bronchoalveolar lavage', 'timeFrame': '10 minutes before surgery ,at the end of surgery immediately', 'description': 'TNF-a,IL-1b,IL-6,IL-8 of BAL will be measured with enzyme-linked immunoassay,all markers will be reported with a unit of pg/ml'}], 'secondaryOutcomes': [{'measure': 'postoperative hospital days', 'timeFrame': 'after surgery up to the time when patient is discharged or dead，it is an average', 'description': 'duration of hospital stay after surgery'}, {'measure': 'incidence rate of acute lung injury', 'timeFrame': 'after surgery up to 28 days', 'description': 'Diagnosis of acute lung injury is followed the consensus criteria for ALI/ARDS published in "Am J Respir Crit Care Med 1994, 149:818-824".'}, {'measure': 'incidence rate of surgical complications', 'timeFrame': 'after surgery up to 28 days', 'description': 'surgical complications include anastomotic fistula, postoperative infection and the patients will be followed until death or discharged'}, {'measure': 'inhospital mortality', 'timeFrame': 'after surgery up to 28 days', 'description': 'the number of death in the period of hospital stay'}, {'measure': 'Oxygenation Index', 'timeFrame': '10 minutes before surgery,at the end of surgery immediately,12h after surgery', 'description': 'Oxygenation Index=PaO2/FiO2'}, {'measure': 'CT scan of chest', 'timeFrame': '12 hours after the surgery', 'description': 'Severity of pulmonary edema will be evaluated by CT scan of chest'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['esophagectomy', 'acute lung injury', 'protective ventilation'], 'conditions': ['Acute Lung Injury']}, 'referencesModule': {'references': [{'pmid': '23993028', 'type': 'DERIVED', 'citation': 'Shen Y, Zhong M, Wu W, Wang H, Feng M, Tan L, Wang Q. The impact of tidal volume on pulmonary complications following minimally invasive esophagectomy: a randomized and controlled study. J Thorac Cardiovasc Surg. 2013 Nov;146(5):1267-73; discussion 1273-4. doi: 10.1016/j.jtcvs.2013.06.043. Epub 2013 Aug 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to determine whether low tidal volume during intraoperative one-lung ventilation could decrease the incidence rate of postoperative acute lung injury compared to "normal" tidal volume.', 'detailedDescription': 'Large tidal volume are known risk factor of acute lung injury.Mechanical ventilation with low tidal volume has been shown to attenuate lung injuries in critically ill patients.Esophagectomy surgery need a relatively long time of one-lung ventilation. A normal tidal volume of two-lung ventilation should be a large one when exerted to one lung. We hypothesized that low tidal volume ventilation during one-lung ventilation could decrease incidence rate of postoperative acute lung injury and mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of esophageal carcinoma and planned for esophagectomy\n* indication for one-lung ventilation\n* informed consent\n* ASA I\\~II\n\nExclusion Criteria:\n\n* NYHA III\\~IV\n* severe COPD\n* pulmonary fibrosis\n* any new pulmonary infiltrate on chest radiograph\n* preoperative acute infection suspected\n* altered liver function( Child-Pugh class B or moe)\n* acute or chronic renal failure\n* preoperative corticosteroid treatment during month before inclusion'}, 'identificationModule': {'nctId': 'NCT01194895', 'briefTitle': 'A Trial to Evaluate the Impact of Lung-protective Intervention in Patients Undergoing Esophageal Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Impact of Intraoperative Protective One-lung Ventilation in Patients Undergoing Esophagectomy : a Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ESO-2010-LV'}, 'secondaryIdInfos': [{'id': 'ESOPV', 'type': 'OTHER', 'domain': 'SICU'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'protective ventilation', 'interventionNames': ['Other: protective ventilation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional ventilation', 'interventionNames': ['Other: conventional ventilation']}], 'interventions': [{'name': 'protective ventilation', 'type': 'OTHER', 'otherNames': ['low tidal volume ventilation'], 'description': 'set tidal volume of 5ml/kg during one-lung ventilation', 'armGroupLabels': ['protective ventilation']}, {'name': 'conventional ventilation', 'type': 'OTHER', 'otherNames': ['normal tidal volume ventilation'], 'description': 'keep tidal volume at 8ml/kg during one-lung ventilation', 'armGroupLabels': ['conventional ventilation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20032', 'city': 'Shanghai', 'country': 'China', 'facility': '180 Fenglin Road', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Zhanggang Xue, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shanghai Zhongshan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'department of anesthesiology and surgical intensive care unit', 'investigatorFullName': 'Ming Zhong', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}