Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT04954118
Status:
COMPLETED
Last Update Posted:
2021-07-08
First Post:
2021-07-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Different Use of The Aerosol Box in COVID-19 Patients; Internal Jugular Vein Cannulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-07', 'studyFirstSubmitDate': '2021-07-04', 'studyFirstSubmitQcDate': '2021-07-07', 'lastUpdatePostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Questionnaire on the Use of Aerosol Boxes', 'timeFrame': '7 months from the index case of the pandemic in Turkey', 'description': 'There is no valid and reliable questionnaire in the literature that evaluates behaviors and attitudes towards aerosol box use. Therefore, in our study, a questionnaire was conducted about the attitudes and behaviors of the participants towards aerosol box preservatives.There are 6 statements in the content of the questionnaire on aerosol box use. The questionnaire consists of expressions such as "1-Discomfort using box, 2-Difficulty in manipulation during the performance, 3-Difficulty in use of US device restricted by box, 4-Increased cognitive load from use of box, 5-Increased physical load from use of box, 6-User satisfaction respectively. Participants were asked to answer these statements as \'\'yes or no\'\'. According to the response received, positive or negative attitudes towards the use of aerosol boxes were evaluated.'}, {'measure': 'Catheter-related infection after central venouse catheterization in COVID-19', 'timeFrame': '7 months from the index case of the pandemic in Turkey', 'description': 'When the body temperature of the patients is above 38, blood, urine and if the patient is intubated, a tracheal aspirate culture will be taken.\n\nIf the blood culture test is a positive, a diagnosis of catheter-related infection will be made and central venouse catheter will be removed.'}], 'secondaryOutcomes': [{'measure': 'Number of arterial punctures', 'timeFrame': '7 months from the index case of the pandemic in Turkey', 'description': 'The difference in the number of arterial punctures developed during central venous catheterization in patients with or without aerosol box.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aerosol box', 'SARS-CoV-2 virus', 'COVID-19', 'Internal jugular vein', 'Personal protective equipment'], 'conditions': ['COVID-19 Pneumonia']}, 'descriptionModule': {'briefSummary': 'During the COVID-19 pandemic, health employees are at high risk of infection. This study aimed to determine experiences with an aerosol box (AB), used with the aim of preventing contamination by droplets during internal jugular vein cannulation which requires close contact with COVID-19 patients, and the necessity to use this device.', 'detailedDescription': 'The study included 40 patients with diagnosis of COVID-19 requiring central venous catheter during treatment in the ward. The patients were randomly allocated to one of the two protective equipment groups and, then, randomly assigned to one of the five clinicians. Group P\\&A had both personal protective equipment (PPE) and AB used, while Group P included patients where PPE was used alone. Clinicians completed a survey after performing the procedure to evaluate the use of the aerosol box. Collected data of the procedures and patients, were analyzed. In addition, survey data were evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with COVID-19 and inserted central venous catheter while being treated in the ward\n\nExclusion Criteria:\n\n* Patients under the age of 18 years\n* Patients who can not lie in the supine position due to severe respiratory distress,\n* Patients with thrombus in the right İJV in evaluation with US'}, 'identificationModule': {'nctId': 'NCT04954118', 'briefTitle': 'A Different Use of The Aerosol Box in COVID-19 Patients; Internal Jugular Vein Cannulation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital'}, 'officialTitle': 'Use of Aerosol Box for Ultrasound-guided Internal Jugular Vein Cannulation in COVID-19 Patients; Single Center Experience', 'orgStudyIdInfo': {'id': '2020-287'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group P', 'description': 'The clinicians performed an internal jugular vein cannulation using only personal protective equipment.', 'interventionNames': ['Procedure: Internal jugular vein cannulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group P&A', 'description': 'The clinicians performed an internal jugular vein cannulation using personal protective equipment and aerosol box.', 'interventionNames': ['Procedure: Internal jugular vein cannulation']}], 'interventions': [{'name': 'Internal jugular vein cannulation', 'type': 'PROCEDURE', 'description': 'The clinicians performed an internal jugular vein cannulation using personal protective equipment (PPE) or both of the aerosol box and PPE provide insertion of a central venous catheter in COVID-19 patients.', 'armGroupLabels': ['Group P', 'Group P&A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34147', 'city': 'Istanbul', 'state': 'Bakirkoy', 'country': 'Turkey (Türkiye)', 'facility': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Gokhan Sertcakacilar, MD', 'investigatorAffiliation': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital'}}}}