Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2026-02-08 @ 1:57 AM
Study NCT ID:
NCT02966392
Status:
COMPLETED
Last Update Posted:
2020-05-29
First Post:
2016-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Endotracheal Cuff Pressure Control to Prevent Ventilator Associated Respiratory Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}, {'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-28', 'studyFirstSubmitDate': '2016-11-09', 'studyFirstSubmitQcDate': '2016-11-14', 'lastUpdatePostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Grade 3 &4 adverse events relating to endotracheal cuff pressure', 'timeFrame': 'From randomisation to 90 days'}], 'primaryOutcomes': [{'measure': 'Ventilator Associated Respiratory Infection (VARI) - defined as Ventilator Associated Pneumonia (VAP) or Ventilator Associated Tracheobronchitis (VAT)', 'timeFrame': 'From randomisation to ICU discharge/death/transfer or 90 days'}], 'secondaryOutcomes': [{'measure': 'Microbiologically confirmed VARI defined as above plus bacterial growth of ≥105 cfu/ml (ETA) or equivalent semi-quantitative for both VAP and VAT', 'timeFrame': 'From randomisation to ICU discharge/death/transfer or 90 days'}, {'measure': 'Clinical and microbiologically confirmed VAP (see above for definitions)', 'timeFrame': 'From randomisation to ICU discharge/death/transfer or 90 days'}, {'measure': 'Intubated days receiving antibiotics', 'timeFrame': 'From randomisation to ICU discharge/death/transfer or 90 days'}, {'measure': 'Incidence of hospital acquired infection', 'timeFrame': 'From randomisation to extubation/death/transfer/discharge/ from ICU or 90 days'}, {'measure': 'Total number of days ventilated/in ICU', 'timeFrame': 'From randomisation to ICU discharge, death, transfer or 90 days'}, {'measure': 'Cost of ICU stay', 'timeFrame': 'From ICU admission to ICU discharge, death, transfer or 90 days'}, {'measure': 'Cost of antibiotics in ICU stay', 'timeFrame': 'From ICU admission to ICU discharge, death, transfer or 90 days'}, {'measure': 'Cost of hospital stay', 'timeFrame': 'From hospital admission to hospital discharge or 90 days'}, {'measure': '28 day mortality', 'timeFrame': 'From randomisation to 28 days after randomisation'}, {'measure': '90 day mortality', 'timeFrame': 'From randomisation to 90 days after randomisation'}, {'measure': 'ICU mortality', 'timeFrame': 'From randomisation to discharge from ICU or death/palliative discharge from it or 90 days'}, {'measure': 'Hospital mortality', 'timeFrame': 'From randomisation to discharge from ICU or death/palliative discharge from it or 90 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cuff pressure', 'Ventilator associated pneumonia', 'Respiratory tract infections'], 'conditions': ['Mechanical Ventilation Complication', 'Tracheal Intubation Morbidity', 'Ventilator-Associated Pneumonia', 'Hospital Acquired Infection']}, 'referencesModule': {'references': [{'pmid': '34420048', 'type': 'DERIVED', 'citation': 'Dat VQ, Minh Yen L, Thi Loan H, Dinh Phu V, Thien Binh N, Geskus RB, Khanh Trinh DH, Hoang Mai NT, Hoan Phu N, Huong Lan NP, Phuong Thuy T, Vu Trung N, Trung Cap N, Tuyet Trinh D, Thi Hoa N, Thi Thu Van N, Luan VTT, Quynh Nhu TT, Bao Long H, Thanh Ha NT, Thi Thanh Van N, Campbell J, Ahmadnia E, Kestelyn E, Wyncoll D, Thwaites GE, Van Hao N, Chien LT, Van Kinh N, Vinh Chau NV, van Doorn HR, Thwaites CL, Nadjm B. Effectiveness of Continuous Endotracheal Cuff Pressure Control for the Prevention of Ventilator-Associated Respiratory Infections: An Open-Label Randomized, Controlled Trial. Clin Infect Dis. 2022 May 30;74(10):1795-1803. doi: 10.1093/cid/ciab724.'}, {'pmid': '29615093', 'type': 'DERIVED', 'citation': 'Dat VQ, Geskus RB, Wolbers M, Loan HT, Yen LM, Binh NT, Chien LT, Mai NTH, Phu NH, Lan NPH, Hao NV, Long HB, Thuy TP, Kinh NV, Trung NV, Phu VD, Cap NT, Trinh DT, Campbell J, Kestelyn E, Wertheim HFL, Wyncoll D, Thwaites GE, van Doorn HR, Thwaites CL, Nadjm B. Continuous versus intermittent endotracheal cuff pressure control for the prevention of ventilator-associated respiratory infections in Vietnam: study protocol for a randomised controlled trial. Trials. 2018 Apr 4;19(1):217. doi: 10.1186/s13063-018-2587-6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether automated cuff pressure control results in a reduction in the proportion of patients developing ventilator associated respiratory infections during their stay in intensive care.', 'detailedDescription': 'The proposed study is a randomized controlled trial of tracheal cuff pressure control using continuous control via an automated electronic device as compared with intermittent pressure control for the prevention of ventilator associated respiratory infection in ICU.\n\nThe study will be conducted at multiple sites in Vietnam. Recruitment will be for 18 months at all centers. Patients experiencing any hospital acquired infection whilst at risk of Ventilator Associated Respiratory Infections will be evaluated in using a standardised investigation protocol to identify cases of VARI and other hospital acquired infections (HAI)s. Assessment of VARI will be based on published criteria and carried out by an endpoint review committee independent of patient care and blinded to the allocation of the patient. Antibiotic use data and duration of stay will be important secondary outcome measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* About to be intubated or intubated for ≤ 24 hours (either oral or tracheostomy)\n* For active treatment\n\nExclusion Criteria:\n\n* previously enrolled in this study\n* previously intubated within 14 days\n* suffering from known tracheomalacia, tracheal stenosis or stridor relating to tracheal injury'}, 'identificationModule': {'nctId': 'NCT02966392', 'acronym': 'VARI-prevent', 'briefTitle': 'Continuous Endotracheal Cuff Pressure Control to Prevent Ventilator Associated Respiratory Infections', 'organization': {'class': 'OTHER', 'fullName': 'Oxford University Clinical Research Unit, Vietnam'}, 'officialTitle': 'A Randomised Controlled Trial of Continuous Endotracheal Cuff Pressure Control for the Prevention of Ventilator Associated Respiratory Infections', 'orgStudyIdInfo': {'id': '16HN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Continuous Pressure Control (CPC)', 'description': 'Continuous endotracheal cuff pressure control using Tracoe cuff pressure controller during their intubated stay on ICU.', 'interventionNames': ['Device: Tracoe cuff pressure controller']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'Intermittent cuff pressure control through manual measurement performed 3 times per day (standard care)'}], 'interventions': [{'name': 'Tracoe cuff pressure controller', 'type': 'DEVICE', 'description': 'Participant will be attached to the cuff pressure controller as soon as possible after enrolment. They will remain attached during their intubated stay. If reintubated during same admission they will continue in the intervention arm. If readmitted to ICU they will be managed according to standard care.', 'armGroupLabels': ['Continuous Pressure Control (CPC)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hanoi', 'country': 'Vietnam', 'facility': 'National Hospital for Tropical Diseases', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}, {'city': 'Ho Chi Minh City', 'country': 'Vietnam', 'facility': 'Hospital for Tropical Diseases', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}, {'city': 'Ho Chi Minh City', 'country': 'Vietnam', 'facility': 'Trung Vuong Hospital', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}], 'overallOfficials': [{'name': 'Behzad Nadjm, MBChB MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oxford University Clinical Research Unit'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We hope to share IPD, however the framework to do so is not yet finalised with our collaborating institutions'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oxford University Clinical Research Unit, Vietnam', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam', 'class': 'UNKNOWN'}, {'name': 'Trung Vuong Hospital, Ho Chi Minh City, Vietnam', 'class': 'UNKNOWN'}, {'name': 'The National Hospital for Tropical Diseases, Ha Noi, Vietnam', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}