Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:19 PM
Study NCT ID:
NCT07284056
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevention and Treatment of Early Postoperative Atelectasis Using The MetaNeb System in Patients Underwent Esophagectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001261', 'term': 'Pulmonary Atelectasis'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 178}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-12-02', 'studyFirstSubmitQcDate': '2025-12-15', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The difference of lung ultrasound scores (LUSS) indicating atelectasis on postoperative day 1 and 2', 'timeFrame': 'From postoperative day 1 to day 2'}], 'secondaryOutcomes': [{'measure': 'The difference of dorsal ventilation region assessed by electrical impedance tomography (EIT) on postoperative day 1 and 2', 'timeFrame': 'From postoperative day 1 to day 2'}, {'measure': 'The difference of PaO2/FiO2 ratios on postoperative day 1 and 2', 'timeFrame': 'From postoperative day 1 to day 2'}, {'measure': 'The number of cases that underwent bronchoscopy intervention during ICU stay', 'timeFrame': 'From admission to ICU discharge'}, {'measure': 'The number of cases that underwent high flow oxygen therapy or mechanical ventilation', 'timeFrame': 'From admission to ICU discharge'}, {'measure': 'Length of ICU stay', 'timeFrame': 'From admission to ICU discharge'}, {'measure': 'The number of cases that develop pneumothorax during intervention', 'timeFrame': 'From admission to the end of intervention at postoperative day 2'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atelectases, Postoperative Pulmonary']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate whether the MetaNeb® System can effectively prevent and treat early postoperative atelectasis in adult patients admitted to ICU after esophagectomy for esophageal cancer.\n\nThe main question it aims to answer is: can the MetaNeb® system significantly reduce the lung ultrasound score (LUSS) indicating atelectasis on postoperative days 1 and 2? Participants will be randomly assigned to either the standard treatment or MetaNeb group, undergo lung ultrasound and electrical impedance tomography (EIT) assessments on postoperative days 1 and 2, receive at least 4 sessions of MetaNeb therapy on postoperative day 1 if in the intervention group, be monitored for oxygenation indices, ICU stay duration, incidence of mechanical ventilation, need for bronchoscopic intervention, and adverse events like pneumothorax.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 18 and 85 years.\n2. Patients who are scheduled for ICU admission after esophagectomy for esophageal cancer.\n\nExclusion Criteria:\n\n1. Presence of an artificial airway at the time of ICU admission.\n2. Planned ICU stay less than 24 hours.\n3. Patients with contraindications to the use of the MetaNeb® System, or those unable to cooperate due to organic or psychiatric conditions.'}, 'identificationModule': {'nctId': 'NCT07284056', 'briefTitle': 'Prevention and Treatment of Early Postoperative Atelectasis Using The MetaNeb System in Patients Underwent Esophagectomy', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Prevention and Treatment of Early Postoperative Atelectasis Using The MetaNeb System in Patients Underwent Esophagectomy', 'orgStudyIdInfo': {'id': 'KY2024847'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Standard Group', 'interventionNames': ['Behavioral: Standard of care']}, {'type': 'EXPERIMENTAL', 'label': 'MetaNeb Group', 'interventionNames': ['Device: MetaNeb Therapy']}], 'interventions': [{'name': 'MetaNeb Therapy', 'type': 'DEVICE', 'description': 'Patients in the MetaNeb group receive at least 4 sessions of MetaNeb therapy on postoperative day 1 (each session includes cycles of CPEP and CHFO modes totaling 10 minutes).', 'armGroupLabels': ['MetaNeb Group']}, {'name': 'Standard of care', 'type': 'BEHAVIORAL', 'description': 'Standard postoperative care, including guidance on coughing and expectoration, turning and back percussion, and early mobilization (getting out of bed for physical activity).', 'armGroupLabels': ['Standard Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Minhui Dong', 'role': 'CONTACT', 'email': 'dong.minhui@zs-hospital.sh.cn', 'phone': '+86 021 64041990', 'phoneExt': '692959'}], 'facility': 'Zhongshan Hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Minhui Dong', 'role': 'CONTACT', 'email': 'dong.minhui@zs-hospital.sh.cn', 'phone': '+86 02164041990', 'phoneExt': '692959'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'It might compromise the interests of MetNeb company and we still need to negotiate it further.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}