Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-02-25 @ 9:42 PM
Study NCT ID:
NCT04091269
Status:
COMPLETED
Last Update Posted:
2021-07-28
First Post:
2019-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IntelliCycleTM 2.0 Improved Patient-ventilator Asynchrony During PSV
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': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'PSV+ Automatic adjustmen of inspiratory triger and cycling-off based on waveform PSV with fixed inspiratory and expiratory NAVA'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-25', 'studyFirstSubmitDate': '2019-09-11', 'studyFirstSubmitQcDate': '2019-09-12', 'lastUpdatePostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asynchrony Index', 'timeFrame': '20 minutes', 'description': 'number of asynchrony events divided by the total neural respiratory rate'}], 'secondaryOutcomes': [{'measure': 'Patient Respiratory Patterns', 'timeFrame': '20 minutes', 'description': 'Patient Respiratory Patterns during Pressure Support Ventilation'}, {'measure': 'gas exchange', 'timeFrame': '20 minutes', 'description': 'Patient gas exchange during Pressure Support Ventilation'}, {'measure': 'work of breathing', 'timeFrame': '20 minutes', 'description': 'work of triggering and respiratory in different arms'}, {'measure': 'other patient-ventilator synchrony parameters', 'timeFrame': '20minutes', 'description': 'trigger and cycle-off asynchrony, Ineffective efforts, double triggering, auto-triggering, premature cycling and late cycling'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['patient-ventilator interation', 'automatic adjustmen of inspiratory triger and cycling-off', 'Neurally controlled PS'], 'conditions': ['Automatic Adjustmen of Inspiratory Triger and Cycling-off']}, 'descriptionModule': {'briefSummary': 'Pressure Support Ventilation use Expiratory triggering sensitivity (Esense) to transfer inspiration to expiration, the value of Esense is fixed. That may lead to asynchrony between humans and ventilators, making people uncomfortable and prolonging weaning time. Furthermore，trigger delay or inffective trigger happens frequently during insppiratory triggering. The ventilators have a compunter drived funcation of automatic adjustmen of inspiratory triger and cycling-off based on waveform, IntelliCycleTM 2.0. It will make the transforming more synchrony with humans. The objectibe of the present study is to detect the effect of automatic adjustmen of inspiratory triger and cycling-off based on waveform on patient-ventilator interation.', 'detailedDescription': 'This is a physiological cross-over study. Enrolled patient with different baseline respiratory mechanics, for example ARDS patients with low compliance, COPD patient with high airway resistance and postoperative patients with almost normal compliance and airway resistance. Patients are ventilated with PSV+ Automatic adjustmen of inspiratory triger and cycling-off based on waveform, PSV with fixed inspiratory and expiratory and NAVA in two different levels of support. The demographic characteristics, diagnosis, formerly medical history, Ventilator indications, Ventilator data, other respiratory treatments, patient-ventilator interation, work of breathing, Eadi, will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPostoperation patients\n\n1. receiving invasive mechanical ventilation due to operation\n2. abdominal surgery, orthopedic surgery or gynecological surgery\n3. without respiratory system Comorbidity\n4. able to sustain PSV more than 1 h with inspiratory support ≤ 15 cmH2O.\n\nCOPD and ARDS patients\n\n1. receiving invasive mechanical ventilation due to acute respiratory failure\n2. able to sustain PSV more than 1 h with inspiratory support ≤ 15 cmH2O.\n\nExclusion Criteria:\n\n1. age \\< 18 or \\>85 years,\n2. tracheostomy at time of inclusion,\n3. contra-indication for nasogastric tube insertion (e.g. history of esophageal varices, gastro-esophageal surgery in the previous 12 months or gastro-esophageal bleeding in the previous 7 days, INR ratio \\> 1.5 , APTT \\> 44 s, history of leukemia),\n4. neuromuscular disease affecting spontaneous breathing (e.g. history of acute central or peripheral nervous system disorder or neuromuscular disease with irregular spontaneous rhythm),\n5. hemodynamic unstable (heart rate \\> 140 beats/min, vasopressors required with ≥ 5 μg.kg-1.min-1 dopamine/ dobutamine, or ≥ 0.2 μg.kg-1.min-1 norepinephrine),\n6. sedation level Richmond Agitation-Sedation Scale (RASS) ≤ -2 or ≥ 2,\n7. lack of informed consent and patients included in other intervention study.'}, 'identificationModule': {'nctId': 'NCT04091269', 'briefTitle': 'IntelliCycleTM 2.0 Improved Patient-ventilator Asynchrony During PSV', 'organization': {'class': 'OTHER', 'fullName': 'Southeast University, China'}, 'officialTitle': 'Automatic Adjustmen of Inspiratory Triger and Cycling-off Based on Waveform Improved Patient-ventilator Interation During Pressure Support Ventilation', 'orgStudyIdInfo': {'id': 'ZDSYLL067-P01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'PSV-10%', 'description': 'PSV mode using E5 ventilator with fixed flow trigger and Esense 10%', 'interventionNames': ['Device: automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PVS-30%', 'description': 'PSV mode using E5 ventilator with fixed flow trigger and Esense 30%', 'interventionNames': ['Device: automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PSV-50%', 'description': 'PSV mode using E5 ventilator with fixed flow trigger and Esense 50%', 'interventionNames': ['Device: automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence']}, {'type': 'EXPERIMENTAL', 'label': 'PSV-auto', 'description': 'PSV mode using automatic adjustmen of inspiratory triger and cycling-off based on waveform', 'interventionNames': ['Device: automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PSV-neuro', 'description': 'NAVA mode using NAVA level of 15 cmH2O/uV and pressure limit function to simulated EAdi triggered PSV.', 'interventionNames': ['Device: automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence']}], 'interventions': [{'name': 'automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence', 'type': 'DEVICE', 'description': 'The ventilators have a compunter drived funcation of automatic adjustmen of inspiratory triger and cycling-off based on waveform, IntelliCycleTM 2.0.', 'armGroupLabels': ['PSV-10%', 'PSV-50%', 'PSV-auto', 'PSV-neuro', 'PVS-30%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Ling Liu', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Ling Liu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zhongda Hospital, School of Medicine, Southeast University,'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southeast University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ling Liu', 'investigatorAffiliation': 'Southeast University, China'}}}}