Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-03-02 @ 3:50 AM
Study NCT ID:
NCT03096106
Status:
COMPLETED
Last Update Posted:
2017-08-07
First Post:
2017-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Visual Assessment for Pressure-time Curve
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-03', 'studyFirstSubmitDate': '2017-03-16', 'studyFirstSubmitQcDate': '2017-03-29', 'lastUpdatePostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the types of pressure time curve by visual inspection.', 'timeFrame': 'up to 10min, from the ventilator screen being frozen to the two observers completing judgement.', 'description': 'the pressure time curves have the three types:the straight,concave,convex,the observers will judge the types of pressure time curve by visual inspection, and record the results of judgement'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Mechanical Ventilation']}, 'referencesModule': {'references': [{'pmid': '29945907', 'type': 'DERIVED', 'citation': 'Sun XM, Chen GQ, Chen K, Wang YM, He X, Huang HW, Luo XY, Wang CM, Shi ZH, Xu M, Chen L, Fan E, Zhou JX. Stress Index Can Be Accurately and Reliably Assessed by Visually Inspecting Ventilator Waveforms. Respir Care. 2018 Sep;63(9):1094-1101. doi: 10.4187/respcare.06151. Epub 2018 Jun 26.'}]}, 'descriptionModule': {'briefSummary': 'Airway pressure-time (P-t) curve and stress index (SI) assessment have been proposed to guide the mechanical ventilation settings and minimize ventilator-induced lung injury.', 'detailedDescription': 'The stress index (SI), which has been proposed to guide the mechanical ventilation settings and minimize ventilator-induced lung injury. It reflects the change of respiratory compliance during inspiration. Value of SI equals to 1 that indicates a constant compliance, whereas values lower and higher than 1 indicate increase and decrease of compliance over inspiratory time, suggesting tidal recruitment and tidal hyperinflation, respectively. Based on the different values of SI showing different shapes, SI of straight curve equals to 1, SI of concave curve lower than 1 and convex curve higher than 1, the investigators speculated that the SI value could be reliably and accurately estimated by visual inspection of the P-t curve.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'intubated and mechanical ventilated by volume-control ventilation with constant flow', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18 years or older; intubated and mechanical ventilated by volume-control ventilation with constant flow;\n\nExclusion Criteria:\n\n* evidence of active air leak from the lung, including bronchopleural fistula, pneumothorax, pneumomediastinum, or existing chest tube; evidence of the stiff chest wall, such as existing the pleural effusion, intra abdominal hypertension, chest injuries and abdominal injuries.'}, 'identificationModule': {'nctId': 'NCT03096106', 'briefTitle': 'Visual Assessment for Pressure-time Curve', 'organization': {'class': 'OTHER', 'fullName': 'Capital Medical University'}, 'officialTitle': 'The Reliability and Validity of Visual Assessment for Pressure-time Curve', 'orgStudyIdInfo': {'id': 'KY2017-016-02'}}, 'armsInterventionsModule': {'interventions': [{'type': 'DEVICE', 'description': 'the investigators just observe the pressure time curve on the ventilation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'ICU, Beijing Tiantan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Jian-xin zhou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tiantan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Capital Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jian-Xin Zhou', 'investigatorAffiliation': 'Capital Medical University'}}}}