Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-28 @ 8:30 PM
Study NCT ID:
NCT05585060
Status:
UNKNOWN
Last Update Posted:
2022-11-22
First Post:
2022-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Changes in End Expiratory Lung Impedence Measured by EIT and End Expiratory Lung Volume Measured by Passive Expiratory in Controlled Mechanical Ventilated Exacerbation COPD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-10-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-19', 'studyFirstSubmitDate': '2022-10-15', 'studyFirstSubmitQcDate': '2022-10-15', 'lastUpdatePostDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the changes of end expiratory lung volume', 'timeFrame': '10 minutes', 'description': 'measured by EIT and IC maneuver'}], 'secondaryOutcomes': [{'measure': 'intrinsic PEEP', 'timeFrame': '10 minutes', 'description': 'measured by Esophageal balloon catheters'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'dynamic pulmonary hyperinflation', 'mechanical ventilation', 'end expiratory lung impedence'], 'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': 'The pathophysiological characteristics of respiratory failure on exacerbation of chronic pulmonary obstructive disease are the rapid deteriorate of respiratory symptoms, combined with aggravated flow limitation, gas trapping, dynamic pulmonary hyperinflation (DPH), therefore the intrinsic PEEP (PEEPi) increases. It is worthwhile to explore bedside methods to quantify the changes in dynamic pulmonary hyperinflation to guide safe and effective mechanical ventilation in airflow limited patients.', 'detailedDescription': 'The study hypothesizes that the electrical impedence tomography (EIT) measured the changes of end expiratory lung impedence (△EELI） could accurately predict the changes of end expiratory lung volume （△EELV） measured by passive expiratory in controlled mechanical ventilated exacerbation COPD patients. The research intended to conduct a research to explore the relationship between △EELI and △EELV induced by external PEEP changes in ventilated exacerbation COPD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 2022.7-2023.1 exacerbation COPD invasive ventilated patients admitted to the first affiliated Guangzhou medical university; 35 to 80 years old; in stable condition judged by clinicians\n\nExclusion Criteria:\n\n* SpO2\\<88%; instable hemodynamic (MAP\\<65mmHg；Norepinephrine\\> 0.1ug/kg.min); pregnancy; 4 hour intravenous diuretics use before research; chest deformity and trauma, subpleural pulmonary bulla; implanted electronic devices(cardiac pacemaker, implantable cardioversion defibrillator,ect); tumour or other organ dysfunction; refuse to signature the informed consent'}, 'identificationModule': {'nctId': 'NCT05585060', 'briefTitle': 'The Changes in End Expiratory Lung Impedence Measured by EIT and End Expiratory Lung Volume Measured by Passive Expiratory in Controlled Mechanical Ventilated Exacerbation COPD Patients', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Guangzhou Medical University'}, 'officialTitle': 'The Relevance and Consistency Study of Changes in End Expiratory Lung Impedence Measured by EIT and End Expiratory Lung Volume Measured by Passive Expiratory in Controlled Mechanical Ventilated Exacerbation COPD Patients', 'orgStudyIdInfo': {'id': 'FAHGuangzhou_20220711'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEEP titration for mechanical ventilated AECOPD patients', 'description': 'Pre- and post-self-controlled trials for invasive mechanical ventilated AECOPD patients during PEEP titration.', 'interventionNames': ['Diagnostic Test: the changes of end expiratory lung impedence', 'Diagnostic Test: the changes of end expiratory lung volume']}], 'interventions': [{'name': 'the changes of end expiratory lung impedence', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['△EELI'], 'description': 'the changes of end expiratory lung impedence measured by EIT', 'armGroupLabels': ['PEEP titration for mechanical ventilated AECOPD patients']}, {'name': 'the changes of end expiratory lung volume', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['△EELV'], 'description': 'the changes of end expiratory lung volume measured by apnea method', 'armGroupLabels': ['PEEP titration for mechanical ventilated AECOPD patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Fu, MD', 'role': 'CONTACT', 'email': 'hooray_009@163.com', 'phone': '+8602083062882'}], 'facility': 'The First Affiliated Hospital of Guangzhou Medical', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Wei Fu, MD', 'role': 'CONTACT', 'email': 'hooray_009@163.com', 'phone': '+8602083062882'}], 'overallOfficials': [{'name': 'Rongchang Chen, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Affiliated Hospital of Guangzhou Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'FuWei', 'investigatorAffiliation': 'The First Affiliated Hospital of Guangzhou Medical University'}}}}