Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2026-01-29 @ 4:59 PM
Study NCT ID:
NCT01864668
Status:
UNKNOWN
Last Update Posted:
2014-02-11
First Post:
2013-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Influence of Tidal Volume to Lung Strain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-02-08', 'studyFirstSubmitDate': '2013-05-21', 'studyFirstSubmitQcDate': '2013-05-28', 'lastUpdatePostDateStruct': {'date': '2014-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the strain in different tidal volume', 'timeFrame': '2 hours', 'description': 'Use the GE ventilator to measure the EELV and calculate the lung strain(lung strain = VT/EELV)'}], 'secondaryOutcomes': [{'measure': '28 days mortality', 'timeFrame': '28 days', 'description': 'Follow up to determine the mortality in 28 days after inclusion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute respiratory distress syndrome', 'lung strain', 'small tidal volume'], 'conditions': ['Critically Ill', 'Acute Respiratory Distress Syndrome']}, 'referencesModule': {'references': [{'pmid': '28159013', 'type': 'DERIVED', 'citation': 'Xie J, Jin F, Pan C, Liu S, Liu L, Xu J, Yang Y, Qiu H. The effects of low tidal ventilation on lung strain correlate with respiratory system compliance. Crit Care. 2017 Feb 3;21(1):23. doi: 10.1186/s13054-017-1600-x.'}]}, 'descriptionModule': {'briefSummary': 'Measure the lung strain in different tidal volume in ADRS patients to find the relationship between tidal volume and lung strain and find the most suitable tidal volume for each patient.', 'detailedDescription': 'Purpose:Find the relationship between tidal volume and lung strain in ARDS patients.Then find the most suitable tidal volume for each patient according to the dividing value.\n\nMethods:Measure the lung strain in the tidal volume of 6mL/kg,8mL/kg,10mL/kg and 12mL/kg in each ARDS patient.\n\nHypothesis:With the increase of the tidal volume,the lung strain develops.In the patient with larger lung compliance,the strain of the group of conventional tidal volume is less than 0.27 and there is no obvious difference between the group of small tidal volume.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Critical patients diagnosed with acute respiratory distress syndrome', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age:18-85,gender is not limited\n2. Needing Invasive ventilation\n3. Fit the definition of ARDS in 2012 "Berlin Definition"\n4. Sign the paper of informed consent\n\nExclusion Criteria:\n\n1. pregnancy and at the end stage of tumour\n2. the COPD patients\n3. less than 24h of mechanical ventilation\n4. more than 5 days of mechanical ventilation\n5. FiO2\\>80%\n6. presence of air leaks\n7. organ dysfunction and hemodynamic instability\n8. including in other research'}, 'identificationModule': {'nctId': 'NCT01864668', 'briefTitle': 'the Influence of Tidal Volume to Lung Strain', 'organization': {'class': 'OTHER', 'fullName': 'Zhongda Hospital'}, 'officialTitle': 'the Influence of Different Tidal Volume to Lung Strain of ARDS Patients', 'orgStudyIdInfo': {'id': '20130519'}}, 'contactsLocationsModule': {'locations': [{'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaohua Qiu, MD', 'role': 'CONTACT', 'email': 'xiaohua0917@163.com', 'phone': '0086-025-83262553'}, {'name': 'Fang Jin, MD', 'role': 'CONTACT', 'email': 'doris_king@163.com', 'phone': '0086-15850601638'}, {'name': 'Fang Jin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xiaohua Qiu, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Affiliated Zhongda Hospital of Southeast University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Xiaohua Qiu, MD', 'role': 'CONTACT', 'email': 'xiaohua0917@163.com', 'phone': '0086-025-83262553'}, {'name': 'Fang Jin, MD', 'role': 'CONTACT', 'email': 'doris_king@163.com', 'phone': '0086-15850601638'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongda Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'physician', 'investigatorFullName': 'Xiaohua Qiu', 'investigatorAffiliation': 'Zhongda Hospital'}}}}