Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-02-28 @ 9:43 PM
Study NCT ID:
NCT05550220
Status:
COMPLETED
Last Update Posted:
2024-03-26
First Post:
2022-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000402', 'term': 'Airway Obstruction'}], 'ancestors': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 586}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-03-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-24', 'studyFirstSubmitDate': '2022-09-19', 'studyFirstSubmitQcDate': '2022-09-21', 'lastUpdatePostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'mortality of 90 days', 'timeFrame': '90 days', 'description': 'mortality of 90 days'}], 'primaryOutcomes': [{'measure': 'fulfilled predefined criteria indicating the need for reintubation within 48 hours following extubation', 'timeFrame': '48 hours', 'description': 'The incidence of fulfilled predefined criteria indicating the need for reintubation within 48 hours following extubation'}], 'secondaryOutcomes': [{'measure': 'Reintubation within 48 hours after extubation', 'timeFrame': '48 hours', 'description': 'The incidence of reintubation within 48 hours after extubation in the ICU.'}, {'measure': 'Post-extubation stridor', 'timeFrame': '24 hours', 'description': 'the occurrence of inspiratory stridor within 24 hours following tracheal extubation.'}, {'measure': 'Invasive mechanical ventilation time before first extubation', 'timeFrame': '28 days', 'description': 'Invasive mechanical ventilation time before first extubation'}, {'measure': 'length of ICU', 'timeFrame': '90 days', 'description': 'the length of patient staying in intensive care unit'}, {'measure': 'length of hospital', 'timeFrame': '90 days', 'description': 'the length of patient staying in hosptial'}, {'measure': 'required reintubation within 48 hours following extubation', 'timeFrame': '48 hours', 'description': 'The incidence of required reintubation within 48 hours after extubation in the ICU.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mechanical Ventilation Complication', 'Weaning Failure', 'Airway Obstruction']}, 'referencesModule': {'references': [{'pmid': '39922534', 'type': 'DERIVED', 'citation': 'Tang X, Gu YM, Shi Y, Li ZM, Cao R, Lu SG, Wu YB, Tao YF, Sun ZY, Yin YJ, Liu CY, Tang XB, Gan GF, Qin XJ, Yin D, Zhao HB, Liu CY, Zhang L, Fang P, Du LS, Li L, Tan H, Li M, Zuo YT, Sun B; Chao-Yang Mechanical Ventilation Study Collaboration Group. Modified Cuff Leak Test for Predicting the Risk of Reintubation in Patients With Invasive Mechanical Ventilation: A Multicenter, Single-Anonymized, Randomized Controlled Trial. Chest. 2025 Jul;168(1):119-130. doi: 10.1016/j.chest.2025.01.033. Epub 2025 Feb 6.'}]}, 'descriptionModule': {'briefSummary': 'We hypothesized that the accuracy of the modified cuff leak test in predicting re-intubation in tracheal intubated patients is better than that of the conventional balloon leak test, thereby further reducing the re-intubation rate.', 'detailedDescription': 'The cuff leak test is an effective method for predicting the occurrence of upper airway obstruction in patients with endotracheal intubation after extubation, with high specificity and moderate sensitivity. However, there is still no clear and unified cuff leak test operation specification. A cohort study has proposed a modified method. When the patient is placed in a semi-recumbent position of 60 degrees and the ventilator is set to a low-flow square wave, it is more predictive than conventional methods. We hypothesized that the accuracy of the modified cuff leak test in predicting re-intubation in tracheal intubated patients is better than that of the conventional balloon leak test, thereby further reducing the re-intubation rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Oral endotracheal intubation and mechanical ventilation \\> 36 hours\n* Fulfilled the weaning criteria\n\nExclusion Criteria:\n\n* The patient has a chest drainage tube and there is persistent air leak\n* Abnormalities of the larynx: such as tumors or vocal cord paralysis\n* The patient cannot maintain the semi-recumbent position\n* Unconventional weaning, such as awake ECMO, etc\n* Participated in the study during the hospitalization\n* Patients or their relatives refused written informed consent'}, 'identificationModule': {'nctId': 'NCT05550220', 'briefTitle': 'A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Chao Yang Hospital'}, 'officialTitle': 'A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients: a Multicenter Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'modified CLT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modified Cuff Leak Test', 'description': "The subject was placed in a semi-recumbent position.\n\nThe subjects were placed in volume assist-control mode with the following parameters:\n\n* respiratory rate 15 breaths/min\n* original oxygen concentration\n* PEEP 0 cm H2O\n* the VT was set according to the subject's stable VT in the previous ventilator mode\n* inspiratory flow was set at 30 L/min with square waveform Positive cutoff value of the air leak volume was 116 mL and the air leak ratio was 0.32.", 'interventionNames': ['Diagnostic Test: Cuff Leak Test']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Cuff Leak Test', 'description': 'The subjects were placed in volume assist-control mode with the following parameters:\n\n* respiratory rate was adapted to patient comfort\n* original oxygen concentration and PEEP\n* the VT about 8ml/Kg IBW\n* inspiratory flow was set at 60 L/min with square waveform Positive cutoff value of the air leak volume was 110 mL and the air leak ratio was 0.15.', 'interventionNames': ['Diagnostic Test: Cuff Leak Test']}], 'interventions': [{'name': 'Cuff Leak Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Cuff leak test is a simple and convenient tool that can be used to predict upper-airway obstruction after extubation. The CLT is used to assess airway patency through listening for an air leak and observing changes in tidal volume (VT) after the cuff is deflated.', 'armGroupLabels': ['Modified Cuff Leak Test', 'Usual Cuff Leak Test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Bing Sun', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor of treatment', 'investigatorFullName': 'Bing Sun', 'investigatorAffiliation': 'Beijing Chao Yang Hospital'}}}}