Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-01 @ 6:58 AM
Study NCT ID:
NCT05081856
Status:
COMPLETED
Last Update Posted:
2024-08-12
First Post:
2021-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use Modular Medical Equipment Vehicle in Mobilization of Patient With Chest Tube
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051346', 'term': 'Mobility Limitation'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Interventional study with posttest control group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-09', 'studyFirstSubmitDate': '2021-08-16', 'studyFirstSubmitQcDate': '2021-10-05', 'lastUpdatePostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'general comfort scale score', 'timeFrame': 'first day and fifth day', 'description': 'monitoring of changes in the general comfort levels of the patients during the intervention'}, {'measure': 'Richard Campell sleep quality scale score', 'timeFrame': 'every day for five days', 'description': 'monitoring of changes in the sleep quality of the patients during the intervention'}, {'measure': 'pain scale score', 'timeFrame': 'every day for five days', 'description': 'monitoring of changes in the pain levels of the patients during the intervention'}, {'measure': 'patient mobility scale score', 'timeFrame': 'every day for five days', 'description': 'monitoring of changes in the mobility of the patients during the intervention'}, {'measure': 'drain removal time (day (median))', 'timeFrame': 'the day the drain was removed', 'description': 'monitoring of changes in the drain removal time of the patients during the intervention'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['care outcomes', 'mobilization', 'chest tube'], 'conditions': ['Mobility Limitation', 'Sleep Quality', 'Pain', 'Comfort', 'Time of the Removal Chest Tube']}, 'descriptionModule': {'briefSummary': 'in this study, it was aimed to examine the effect of the modular carrying system on the outcomes of care in the mobilization of patients with a chest tube. The population of the study consisted of patients followed in Yedikule Chest Diseases, and Thoracic Surgery Training and Research Hospital between October 2019 and January 2021, and the sample consisted of 83 patients who met the inclusion criteria. The study was performed with the intervention group (n=37) mobilized with the Modular medical equipment carrying vehicle and the control group (n=46) mobilized with the routine application.', 'detailedDescription': 'Within the scope of the study, a Modular medical equipment carrying vehicle was developed by the researchers to ensure the safe and comfortable mobilization of patients with chest tube and additional medical equipment. This vehicle has been designed to maintain the level of the chest tube during mobilization and to prevent it from tipping over.Patients in the intervention group were mobilized with the help of this Modular medical equipment carrying vehicle for 20 minutes at least 6 times a day. Patients in the control group were mobilized at least 6 times a day for 20 minutes with clinical routine practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chest tube inserted due to open surgery, hemodynamically stable, followed up in the clinic for at least 5 days, first mobilized after chest tube inserted\n\nExclusion Criteria:\n\n* have a mental or psychological illness, hemodynamically unstable'}, 'identificationModule': {'nctId': 'NCT05081856', 'briefTitle': 'Use Modular Medical Equipment Vehicle in Mobilization of Patient With Chest Tube', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medipol University Hospital'}, 'officialTitle': 'The Effect of Modular Carrying System on Patient Outcomes in the Mobilization of Patients With a Chest Tube', 'orgStudyIdInfo': {'id': '12093487'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': 'The group mobilized for at least 20 minutes 6 times a day with a modular medical equipment carrying vehicle', 'interventionNames': ['Other: mobilization with moduler medical equipment carring vehicle']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'The group mobilized for at least 20 minutes 6 times a day with a routin practice'}], 'interventions': [{'name': 'mobilization with moduler medical equipment carring vehicle', 'type': 'OTHER', 'description': 'Mobilization of the patients was carried out with the vehicle in their modular vehicle.', 'armGroupLabels': ['intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medipol University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Pınar Dogan, Asst.Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medipol University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'Data will be used for 2 years', 'ipdSharing': 'YES', 'description': 'Data from the study will be reported over the levels of change in maintenance results. The study report is aimed to be published as a clinical research report.', 'accessCriteria': 'increase in sleep, comfort and mobility level of patients mobilized with this tool, decrease in pain and drain removal time'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medipol University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst.Prof.', 'investigatorFullName': 'pınar dogan', 'investigatorAffiliation': 'Istanbul Medipol University Hospital'}}}}