Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2025-12-26 @ 2:25 AM
Study NCT ID:
NCT05378802
Status:
COMPLETED
Last Update Posted:
2023-08-15
First Post:
2021-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predict Transpulmonary Pressure Through ZAM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-14', 'studyFirstSubmitDate': '2021-11-06', 'studyFirstSubmitQcDate': '2022-05-12', 'lastUpdatePostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Predicted transpulmonary pressure', 'timeFrame': '6 hours', 'description': 'Transpulmonary pressure calculated from airway pressure by Prediction formula'}], 'secondaryOutcomes': [{'measure': 'patient-ventilator breath contribution', 'timeFrame': '6 hours', 'description': 'An index for quantifying the respective patient and ventilator breath contributions'}, {'measure': 'inspiratory flow', 'timeFrame': '6 hours', 'description': 'the inspiratory flow measured by the ventilator'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '39365383', 'type': 'DERIVED', 'citation': 'Liu L, He H, Liang M, Beck J, Sinderby C. Estimation of transpulmonary driving pressure using a lower assist maneuver (LAM) during synchronized ventilation in patients with acute respiratory failure: a physiological study. Intensive Care Med Exp. 2024 Oct 4;12(1):89. doi: 10.1186/s40635-024-00674-z.'}]}, 'descriptionModule': {'briefSummary': 'Stable patient with ARF spontaneously breathing light sedation (not too awake but with stable breathing pattern) and EAdi \\>8 uV. Four modes of mechanical ventilation were performed under different support level for the measuring of EAdi, air way pressure and other parameters.', 'detailedDescription': "1. Mode NAVA spontaneous breathing select a NAVA level that gives peak pressure about 9-10 cm H2O assist keep NAVA level for 15 minutes, do ZAM breaths every 3 minutes (make sure not to disturb the patient). Insp Hold after every ZAM.\n\n Increase NAVA level by 50% and repeat the protocol when patient's breathing has stabilized (only one increase).Do ZAM breaths every 3 minutes (make sure not to disturb the patient). Insp Hold after every ZAMAt the end of protocol (minute 15) do one end-inspiratory hold-maneuver and one end-expiratory occlusion.\n2. Mode N- PSV spontaneous breathing :PS level of 8-10 cmH2O, keep PS level for 15 minutes, do ZAM every 3 minutes (make sure not to disturb patient). Inspiratory Hold after every ZAM。At the end of protocol (minute 15) do one end-inspiratory hold-maneuver and one end-expiratory occlusion.Increase PS by 50% and repeat protocol when patient's breathing has stabilized (only 1 increase). Do ZAM every 3 minutes (make sure not to disturb patient). Inspiratory Hold after every ZAM.At the end of protocol (minute 15) do one end-inspiratory hold-maneuver and one end-expiratory occlusion.\n\n Make record of RR, Vt, Flow, Ti during both periods.\n3. Mode VCV no spontaneous breathing：Set Vt, Ti and RR to match the breathing pattern observed during NAVA\n4. Mode PCV no spontaneous breathing-do ZAM after each PS level：Increase PSV level from 8 to 20 in steps of 1 cmH2O every 2 minutes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable patient with acute respiratory failure on invasive mechanical ventilation Can tolerate pressure support ventilation light sedation with RASS between -2 and 1\n\nExclusion Criteria:\n\n* EAdi\\<8 uV contraindication for nasogastric tube insertion neuromuscular disease affecting spontaneous breathing lack of informed consent, and patients included in other intervention study'}, 'identificationModule': {'nctId': 'NCT05378802', 'briefTitle': 'Predict Transpulmonary Pressure Through ZAM', 'organization': {'class': 'OTHER', 'fullName': 'Southeast University, China'}, 'officialTitle': 'Comparison of Spontaneous Breathing and Controlled Ventilation', 'orgStudyIdInfo': {'id': 'ZAM study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NAVA mode', 'description': "1. st select a NAVA level that gives peak pressure about 9-10 cm H2O assist keep NAVA level for 15 minutes, do ZAM breaths every 3 minutes (make sure not to disturb the patient). Insp Hold after every ZAM\n2. nd increase NAVA level by 50% and repeat the protocol when patient's breathing has stabilized (only one increase) Do ZAM breaths every 3 minutes (make sure not to disturb the patient). Insp Hold after every ZAM", 'interventionNames': ['Other: different modes of mechanical ventilation']}, {'type': 'EXPERIMENTAL', 'label': 'N- PSV mode', 'description': "1. st PS level of 8-10 cmH2O, keep PS level for 15 minutes, do ZAM every 3 minutes (make sure not to disturb patient). Insp Hold after every ZAM At the end of protocol (minute 15) do one end-inspiratory hold-maneuver and one end-expiratory occlusion.\n2. nd increase PS by 50% and repeat protocol when patient's breathing has stabilized (only 1 increase). Do ZAM every 3 minutes (make sure not to disturb patient). Insp Hold after every ZAM", 'interventionNames': ['Other: different modes of mechanical ventilation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'VCV mode', 'description': 'no spontaneous breathing Set Vt, Ti and RR to match the breathing pattern observed during NAVA. Make sure each change in "level" does not increase the pressure by more than 1 cmH2O.\n\nMode PCV no spontaneous breathing-do ZAM after each PS level Increase PSV level from 8 to 20 in steps of 1 cmH2O every 2 minutes. Be careful at the higher pressures.', 'interventionNames': ['Other: different modes of mechanical ventilation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PCV mode', 'description': 'Increase PSV level from 8 to 20 in steps of 1 cmH2O every 2 minutes. Be careful at the higher pressures The idea is not to have pressures as high as 20 cmH2O, it is important to have high enough VCV \\& PCV flow rates so we can match the flow rates during spontaneous breathing. You might find that 15 or 16 cmH2O is enough to generate flow rates that match the "maximum" flow rate you saw during spontaneous breathing.', 'interventionNames': ['Other: different modes of mechanical ventilation']}], 'interventions': [{'name': 'different modes of mechanical ventilation', 'type': 'OTHER', 'description': 'Four different ventilation modes were performed one by one and respiratory parameters were recorded.', 'armGroupLabels': ['N- PSV mode', 'NAVA mode', 'PCV mode', 'VCV mode']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Zhongda hospital, Southeast university', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Haibo Qiu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southeast University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is a physiological study, we do not intend to disclose the data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southeast University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Ling Liu', 'investigatorAffiliation': 'Southeast University, China'}}}}