Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-03 @ 6:36 AM
Study NCT ID:
NCT02623634
Status:
COMPLETED
Last Update Posted:
2021-06-14
First Post:
2015-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Different Postures and Ventilator Flow Waveforms on the Cuff Leak Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D056888', 'term': 'Patient Positioning'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-11', 'studyFirstSubmitDate': '2015-11-13', 'studyFirstSubmitQcDate': '2015-12-03', 'lastUpdatePostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post-extubation stridor', 'timeFrame': '48 hours', 'description': 'Inspiratory stridor within 48 hours of extubation and was usually associated with respiratory distress'}], 'secondaryOutcomes': [{'measure': 'Extubation failure due to PES', 'timeFrame': '48 hours', 'description': 'the need for reintubation in the 48 hours following extubation in a patient with post-extubation stridor.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cuff leak test, relative factors'], 'conditions': ['Cuff Leak Volume']}, 'referencesModule': {'references': [{'pmid': '15693963', 'type': 'RESULT', 'citation': 'Prinianakis G, Alexopoulou C, Mamidakis E, Kondili E, Georgopoulos D. Determinants of the cuff-leak test: a physiological study. Crit Care. 2005 Feb;9(1):R24-31. doi: 10.1186/cc3012. Epub 2004 Nov 29.'}, {'pmid': '1999096', 'type': 'RESULT', 'citation': 'Kemper KJ, Benson MS, Bishop MJ. Predictors of postextubation stridor in pediatric trauma patients. Crit Care Med. 1991 Mar;19(3):352-5. doi: 10.1097/00003246-199103000-00012.'}, {'pmid': '3396380', 'type': 'RESULT', 'citation': 'Potgieter PD, Hammond JM. "Cuff" test for safe extubation following laryngeal edema. Crit Care Med. 1988 Aug;16(8):818. doi: 10.1097/00003246-198808000-00020. No abstract available.'}, {'pmid': '23744958', 'type': 'RESULT', 'citation': 'El-Orbany M, Salem MR. Endotracheal tube cuff leaks: causes, consequences, and management. Anesth Analg. 2013 Aug;117(2):428-34. doi: 10.1213/ANE.0b013e318292ee21. Epub 2013 Jun 6.'}]}, 'descriptionModule': {'briefSummary': 'the purpose of this study is to analyzes the factors influencing the results of cuff leak test, in order to improve the cuff leak test on the accuracy of the prediction on airway edema after extubation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients in RICU of Beijing chaoyang hospital with tracheal intubation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intubation less than 24 hours before amitting respiratory intensive care unit;\n\nExclusion Criteria:\n\n* unstable hemodynamics;PEEP≥10cmH2O or FiO2≥0.8'}, 'identificationModule': {'nctId': 'NCT02623634', 'briefTitle': 'Effects of Different Postures and Ventilator Flow Waveforms on the Cuff Leak Test', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Chao Yang Hospital'}, 'officialTitle': 'Effects of Different Postures and Ventilator Flow Waveforms on the Cuff Leak Test: A Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'Bei Jing Chao Yang Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'observation', 'description': 'this study measure the cuff leak volume and cuff leak ratio according to the cuff leak test with different positions and waveform,, at the same time observe the patient general condition, vital signs, oxygen saturation, cuff leak test results under different conditions and the breathing machine parameters, the diameter of the airway, the use of sedatives and hormones, after extubation stridor and intubation is happening again, the use of NPPV after extubation, patient outcomes', 'interventionNames': ['Behavioral: Position, waveform']}], 'interventions': [{'name': 'Position, waveform', 'type': 'BEHAVIORAL', 'description': 'different positions and waveform', 'armGroupLabels': ['observation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Chao Yang Hospital RICU', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Huiwen Chu, bachelor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beijing Chao Yang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master', 'investigatorFullName': 'Huiwen Chu', 'investigatorAffiliation': 'Beijing Chao Yang Hospital'}}}}