Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2026-02-11 @ 4:36 AM
Study NCT ID:
NCT03076450
Status:
UNKNOWN
Last Update Posted:
2017-05-02
First Post:
2017-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of POC Lung Ultrasound Combined With Pressure-volume Curve to Titration Adjust PEEP for ARDS Lung Recruitment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D018879', 'term': 'Ventricular Premature Complexes'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D005117', 'term': 'Cardiac Complexes, Premature'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2018-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-29', 'studyFirstSubmitDate': '2017-03-07', 'studyFirstSubmitQcDate': '2017-03-09', 'lastUpdatePostDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung Ultrasound re-aeration score, LUS-RAS', 'timeFrame': '48 hours', 'description': 'The score is composed of 12 different regions of chest wall checked by POC-LUS.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute respiratory distress syndrome, ARDS', 'Point-of-care lung ultrasound,POC-LUS', 'Pressure-volume curve, PVC', 'Positive end-expiratory pressure, PEEP', 'Ultrasound re-aeration score, US-RAS'], 'conditions': ['Acute Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': 'Using lung ultrasound re-aeration score(LUS-RAS) combined with pressure-volume curve(PVC) adjust maintain positive end-expiratory pressure(PEEP) after recruitment maneuver, to achieve real-time adjustment, reduce ventilation-associated lung injury and the purpose of effective lung recruitment.', 'detailedDescription': 'The traditional method, set PEEP according to PVC in ARDS mechanical ventilation, lacks morphological evaluation. For point-of-care lung ultrasound(POC-LUS) is non-invasive, real-time, visualization, no need transport patients, getting more and more attention in the ARDS treatment. It has been reported that LUS-RAS is a meaningful assessment in recruitment maneuver. This study will combine POC-LUS with PVC in set the initial peep, and then dynamic record LUS-RAS to feedback regulate PEEP. Using the POC-LUS and maximum oxygenation method to assess lung recruitment effect in experimental group and control group prospectively. The ventilator parameters, state of hemodynamic, arterial blood gas(ABG) in each group will be recorded; Statistical methods will be performed in term to understand the correlation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient aged 18 years and older\n* ARDS patients with invasive mechanical ventilation\n\nExclusion Criteria:\n\n* Intracranial hypertension\n* Pneumothorax and mediastinal emphysema\n* Severe hypoxemia (oxygenation index \\<100)\n* Hemodynamic instability\n* Chest deformity or surgical history\n* Affect Lung-ultrasound conditions: subcutaneous emphysema, chest wound etc.'}, 'identificationModule': {'nctId': 'NCT03076450', 'briefTitle': 'Evaluation of POC Lung Ultrasound Combined With Pressure-volume Curve to Titration Adjust PEEP for ARDS Lung Recruitment', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Pudong New Area Gongli Hospital'}, 'officialTitle': 'Clinical Evaluation of Point-of-care Lung Ultrasound Combined With Pressure-volume Curve to Titration Adjust PEEP for ARDS Lung Recruitment', 'orgStudyIdInfo': {'id': '201640405'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Maximum Oxygenation', 'description': 'Using PVC to set the initial peep, check ABG real-time, and according to PaO2+PaCO2≥400mmHg whether or not to adjust maintain PEEP.', 'interventionNames': ['Diagnostic Test: Maximum Oxygenation']}, {'type': 'EXPERIMENTAL', 'label': 'Lung Ultrasound Re-aeration Score', 'description': 'Combine POC-LUS with PVC in set the initial peep, and then dynamic record LUS-RAS to feedback regulate PEEP.', 'interventionNames': ['Device: Lung Ultrasound']}], 'interventions': [{'name': 'Lung Ultrasound', 'type': 'DEVICE', 'description': 'Adjust PEEP real-time in term of LUS-RAS chang.', 'armGroupLabels': ['Lung Ultrasound Re-aeration Score']}, {'name': 'Maximum Oxygenation', 'type': 'DIAGNOSTIC_TEST', 'description': 'Adjust PEEP real-time in term of PaO2+PaCO2≥400mmHg whether or not.', 'armGroupLabels': ['Maximum Oxygenation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200135', 'city': 'Pudong', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiancheng Luo, MM', 'role': 'CONTACT', 'email': 'luoqiancheng19@163.com', 'phone': '008613564781737'}], 'facility': 'Gongli Hospital', 'geoPoint': {'lat': 31.23995, 'lon': 121.50094}}], 'centralContacts': [{'name': 'Qiancheng Luo, MM', 'role': 'CONTACT', 'email': 'luoqiancheng19@163.com', 'phone': '008613564781737'}], 'overallOfficials': [{'name': 'Qiancheng Luo, MM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Pudong New Area Gongli Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Pudong New Area Gongli Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Municipal Commission of Health and Family Planning', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending-doctor of Critical Care Medcine, Principal Investigator', 'investigatorFullName': 'Qiancheng Luo', 'investigatorAffiliation': 'Shanghai Pudong New Area Gongli Hospital'}}}}