Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-04 @ 7:32 AM
Study NCT ID:
NCT04053751
Status:
COMPLETED
Last Update Posted:
2022-05-27
First Post:
2019-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Open and Closed System Suctioning on Suctioning Frequency and Amount of Secretion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012798', 'term': 'Sialorrhea'}], 'ancestors': [{'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized controlled crossover trial. There are two arms. open and closed suctioning systems (OSS vs CSS). the patients are randomized. They are monitorized for two days. If a patient is suctioned via OSS in the first enrolled day, the same patient is suctioned via CSS in the second enrolled day. For CSS, vice versa.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-26', 'studyFirstSubmitDate': '2019-08-09', 'studyFirstSubmitQcDate': '2019-08-09', 'lastUpdatePostDateStruct': {'date': '2022-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'frequency of suctioning', 'timeFrame': '12 hours of a day', 'description': 'frequency of suctioning in a half of a day'}, {'measure': 'amount of secretion', 'timeFrame': '12 hours of a day', 'description': 'amount of secretion in a half of a day'}], 'secondaryOutcomes': [{'measure': 'spo2', 'timeFrame': '12 hours of a day', 'description': 'differences in spo2 between open and closed suctioning systems'}, {'measure': 'tidal volume', 'timeFrame': '12 hours of a day', 'description': 'differences in tidal volume between open and closed suctioning systems'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intensive care unit', 'endotracheal suctioning', 'open suctioning system', 'closed suctioning system', 'nursing'], 'conditions': ['Secretion; Excess, Salivation']}, 'referencesModule': {'references': [{'pmid': '37833132', 'type': 'DERIVED', 'citation': 'Yilmaz I, Ozden D. The effects of open and closed system endotracheal suctioning methods on suctioning frequency, amount of secretion, and haemodynamics: A single-blind, randomised, 2 x 2 crossover trial. Aust Crit Care. 2024 Jan;37(1):25-33. doi: 10.1016/j.aucc.2023.09.002. Epub 2023 Oct 11.'}]}, 'descriptionModule': {'briefSummary': "Tracheal suctioning is a process which is often applied to patients' care who have an artificial airway and whose respiration is achieved via mechanical ventilation. When secretions are not cleaned enough, it causes a variety of complications in the patient from hypoxemia to infection.\n\nIt is reported that the studies with nurses in clinical practice have shown that they have opinions such as the closed system does not suction the patients effectively as the open system does; it remains incapable in removing secretions, thus the suctioning process is being applied more frequently.\n\nTherefore this study is designed to examine the amount of secretions and frequency of suctioning as a result of open and closed suctioning systems.", 'detailedDescription': 'Patients will be monitored for two days. On the first day, the patient will be followed up with an open system and the second day closed suctioning system will be used, or the patient will be followed up with a closed system on the first day and followed with an open system on the second day. The patients are randomly allocated on the first follow up days. The follow-up period has two consecutive days. suctioning will be performed for 12 hours in one day. The number of suctions will be recorded. The amount of secretion will be accumulated in the mucus collection vessel. At the end of the day, the secretion will be weighed with precision weighing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* orally intubated in first 96 hours\n* stabilized patients in conditionally\n* platelets \\> 50.000\n* not have hemorrhagic secretions\n\nExclusion Criteria:\n\n* hemodynamically unstabilized patients'}, 'identificationModule': {'nctId': 'NCT04053751', 'briefTitle': 'Effects of Open and Closed System Suctioning on Suctioning Frequency and Amount of Secretion', 'organization': {'class': 'OTHER', 'fullName': 'Dokuz Eylul University'}, 'officialTitle': 'Effects of Open and Closed System Endotracheal Suctioning Methods on Suctioning Frequency and Amount of Secretion', 'orgStudyIdInfo': {'id': '2018.KB.SAG.025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'closed suctioning system', 'description': 'Closed suctioning system will be compared with open suctioning system', 'interventionNames': ['Procedure: closed suctioning system']}, {'type': 'NO_INTERVENTION', 'label': 'open suctioning system', 'description': 'The patient will be monitored with closed system for one day and open aspiration system on the other day.'}], 'interventions': [{'name': 'closed suctioning system', 'type': 'PROCEDURE', 'description': 'a randomized allocated patient will be monitored for two days. Closed suctioning system will evaluate as experimental group. open suctioning system will evaluate as control group.', 'armGroupLabels': ['closed suctioning system']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Dokuz Eylul University', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Dilek Ozden, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dokuz Eylul University Faculty of Nursing'}, {'name': 'Ilkin Yilmaz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dokuz Eylul University Faculty of Nursing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share the patients data with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dokuz Eylul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assisstant', 'investigatorFullName': 'Ilkin Yilmaz', 'investigatorAffiliation': 'Dokuz Eylul University'}}}}