Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-01-04 @ 7:41 PM
Study NCT ID:
NCT04802668
Status:
COMPLETED
Last Update Posted:
2023-01-10
First Post:
2021-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Influencing of Pulse Pressure Variation (PPV)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 189}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-07', 'studyFirstSubmitDate': '2021-02-06', 'studyFirstSubmitQcDate': '2021-03-15', 'lastUpdatePostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pes', 'timeFrame': '1 day', 'description': 'esophageal pressure'}, {'measure': 'transpulmonary pressure', 'timeFrame': '1 day', 'description': 'transpulmonary pressure and delta transpulmonary pressure'}, {'measure': 'Outcome', 'timeFrame': '28 day', 'description': 'ICU， 28day and hospital mortality'}], 'primaryOutcomes': [{'measure': 'cardiac output(CO)', 'timeFrame': '1 day', 'description': 'The measurement of cardiac output(CO);'}], 'secondaryOutcomes': [{'measure': 'measurement of Hemodynamic variables from the monitor;', 'timeFrame': '1 day', 'description': 'The investigators record the hemodynamic variables from the monitor MAP and CVP'}, {'measure': 'measurement of Pulse pressure variation（PPV）from monitor;', 'timeFrame': 'Research period', 'description': 'Pulse pressure variation (PPV)(percent) ,whic is calculated from the systolic and diastolic blood pressure,can be read from the monitor directly.'}, {'measure': 'measurement of airway pressure variables from ventilator', 'timeFrame': '1 day', 'description': 'The investigators record the airway pressure variables during the inspiration and expiration from the ventilator'}, {'measure': 'P 0.1', 'timeFrame': '1 day', 'description': 'airway occlusion pressure at 100 milliseconds after the onset of inspiration (P0.1)(cmH2O)'}, {'measure': 'Pocc', 'timeFrame': '1 day', 'description': 'delta change of airway pressure during expiratory occlusion in different interventions.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['haemodynamics;', 'Pulse pressure variation;', 'fluid responsiveness;', 'Mechanical ventilation;'], 'conditions': ['Haemodynamics', 'Fluid Responsiveness', 'Pulse Pressure Variation']}, 'referencesModule': {'references': [{'pmid': '37592166', 'type': 'DERIVED', 'citation': 'Chen H, Liang M, He Y, Teboul JL, Sun Q, Xie J, Yang Y, Qiu H, Liu L. Inspiratory effort impacts the accuracy of pulse pressure variations for fluid responsiveness prediction in mechanically ventilated patients with spontaneous breathing activity: a prospective cohort study. Ann Intensive Care. 2023 Aug 17;13(1):72. doi: 10.1186/s13613-023-01167-0.'}]}, 'descriptionModule': {'briefSummary': 'The investigators studied the predictive value of PPV in the patients with different influencing factors;and the method to improve the predictive value,which can improve the application of PPV in ICU.', 'detailedDescription': 'PPV can be used to predict fluid responsiveness in patients with circulatory shock.However, it is affected by many factors, which leads to the decrease of the applicability of PPV in ICU.Therefore, the investigators studied the predictive value of PPV in the patients with different influencing factors;and the method to improve the predictive value,which can improve the application of PPV in ICU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with circulatory failure selected to enter the Department of Critical Care Medicine', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients requiring invasive mechanical ventilation\n* Acute circulatory failure,defined as:systolic blood pressure \\<90 mmHg or blood pressure in patients with previous hypertension lower than the baseline value\\> 40 mmHg; vasoactive drugs are required to maintain blood pressure (mean arterial pressure\\> 65 mmHg); with or without signs of hypoperfusion (oliguria\\<0.5ml.kg-1.h-1 for at least 2 hours; arterial blood lactic acid\\>2.5mmol.L-1; skin mottling)\n\nExclusion Criteria:\n\n* The age of the patient is less than 18 years old or more than 80 years old\n* Refuse to sign the informed consent to join the group\n* Atrial fibrillation and other arrhythmias that seriously affect the output per beat;\n* With pregnancy\n* Other situations where the clinician believes that the patient is not suitable for inclusion in the study'}, 'identificationModule': {'nctId': 'NCT04802668', 'acronym': 'FacPPV', 'briefTitle': 'Factors Influencing of Pulse Pressure Variation (PPV)', 'organization': {'class': 'OTHER', 'fullName': 'Southeast University, China'}, 'officialTitle': 'Factors Influencing the Reliability of Pulse Pressure Variation (PPV) as a Predictor of Fluid Responsiveness in Mechanically Ventilated Patients', 'orgStudyIdInfo': {'id': '20210101PPV'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Circulatory failure patients', 'description': 'Circulatory failure patients requiring fluid responsiveness evaluation', 'interventionNames': ['Device: Patients were ventilated with assist-control ventilation（A/C） mode at different tidal volume', 'Behavioral: spontaneous breathing and no spontaneous breathing']}], 'interventions': [{'name': 'Patients were ventilated with assist-control ventilation（A/C） mode at different tidal volume', 'type': 'DEVICE', 'description': 'Ventilation mode was set to assist-control volume ventilation with different tidal volume, respiratory frequency 15 times/min, PEEP 5 centimeter water column.', 'armGroupLabels': ['Circulatory failure patients']}, {'name': 'spontaneous breathing and no spontaneous breathing', 'type': 'BEHAVIORAL', 'description': 'Data were recorded when patients had and did not have spontaneous breathing', 'armGroupLabels': ['Circulatory failure patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Ling Liu', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Haibo Qiu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southeast University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Ling Liu', 'investigatorAffiliation': 'Southeast University, China'}}}}