Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-30 @ 8:26 AM
Study NCT ID:
NCT07035756
Status:
RECRUITING
Last Update Posted:
2025-06-25
First Post:
2025-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of an Arterial Pressure Monitoring Set Fixation Apparatus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The study is not blinded; participants and investigators know which intervention is used.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': "Participants will be enrolled sequentially and receive the new arterial pressure monitoring set fixation device. Data on fixation stability, patient comfort, and hemodynamic parameters will be collected over 48 hours postoperatively to assess the device's performance."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-20', 'studyFirstSubmitDate': '2025-06-12', 'studyFirstSubmitQcDate': '2025-06-20', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of Invasive Blood Pressure and Central Venous Pressure Measurements', 'timeFrame': 'Within the first 48 hours of monitoring', 'description': 'The accuracy of arterial and central venous pressure measurements obtained using the developed fixation device will be compared to those obtained using standard adhesive tape fixation. Accuracy will be determined by evaluating waveform stability and consistency of numeric readings during patient movement and routine care.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Arterial Pressure Monitoring', 'Fixation Device', 'Coronary Artery Bypass Graft (CABG)', 'Hemodynamic Monitoring', 'Postoperative Care'], 'conditions': ['Coronary Artery Bypass Graft Surgery']}, 'referencesModule': {'references': [{'pmid': '32310587', 'type': 'RESULT', 'citation': 'Nguyen Y, Bora V. Arterial Pressure Monitoring. 2023 Mar 19. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK556127/'}]}, 'descriptionModule': {'briefSummary': "This study aims to develop an arterial pressure monitoring set fixation device and evaluate its effectiveness in clinical settings. The device is designed to increase the stability and comfort of arterial pressure monitoring during patient care. An experimental study will be conducted with patients requiring arterial pressure monitoring. The device's effectiveness will be evaluated by measuring fixation stability and postoperative arterial blood pressure-CVP parameters over 48 hours. The study aims to demonstrate that the new fixation device can improve patient safety and monitoring accuracy compared to the standard method using adhesive tape, thereby contributing to better clinical outcomes.", 'detailedDescription': "This study focuses on the development of a novel arterial pressure monitoring set fixation device designed to enhance stability and comfort during invasive arterial pressure measurement. The device securely fixes the monitoring set in place, reducing movement and potential complications caused by displacement or discomfort associated with the adhesive tapes currently in use.\n\nAn experimental study design will be employed. Sixty patients requiring postoperative invasive arterial pressure monitoring will be included based on predefined inclusion and exclusion criteria. The fixation device will be applied to these patients.\n\nFixation stability, patient comfort, and hemodynamic parameters, including arterial blood pressure and central venous pressure (CVP), will be measured over a 48-hour postoperative period. The data will be analyzed to evaluate the device's effectiveness in improving monitoring accuracy and patient safety.\n\nEthical approval has been obtained from the relevant institutional review board, and compliance with human subject protection standards will be maintained throughout the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients aged 18-80 years\n* Patients undergoing arterial catheterization for invasive blood pressure and CVP monitoring\n* Patients able to provide informed consent\n* Hemodynamically stable patients undergoing Coronary Artery Bypass Grafting (CABG)\n\nExclusion Criteria:\n\n* Patients younger than 18 or older than 80 years\n* Patients with coagulopathy or bleeding disorders\n* Patients with local infection or skin lesions at the catheter insertion site\n* Patients unable to provide informed consent\n* Hemodynamically unstable patients\n* Patients with known allergy to device materials or adhesive tapes'}, 'identificationModule': {'nctId': 'NCT07035756', 'briefTitle': 'Development of an Arterial Pressure Monitoring Set Fixation Apparatus', 'organization': {'class': 'OTHER', 'fullName': 'Yuzuncu Yil University'}, 'officialTitle': 'Development of an Arterial Pressure Monitoring Set Fixation Apparatus and Evaluation of Its Effectiveness', 'orgStudyIdInfo': {'id': '2024/08-09'}, 'secondaryIdInfos': [{'id': 'TDK-2024-14774', 'type': 'OTHER_GRANT', 'domain': 'Atatürk Univ. Sci. Res. Projects Coord. Unit'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arterial Pressure Monitoring Set Fixation Device Group', 'description': 'This group includes patients who will receive the new arterial pressure monitoring set fixation device. The device is applied postoperatively to secure arterial pressure monitoring and improve fixation stability and patient comfort over a 48-hour period.', 'interventionNames': ['Device: Arterial Pressure Monitoring Set Fixation Device']}], 'interventions': [{'name': 'Arterial Pressure Monitoring Set Fixation Device', 'type': 'DEVICE', 'description': 'A newly developed fixation device designed to securely stabilize the arterial pressure monitoring set, improving patient comfort and reducing device displacement during the postoperative period in patients undergoing coronary artery bypass graft surgery.', 'armGroupLabels': ['Arterial Pressure Monitoring Set Fixation Device Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65000', 'city': 'Van', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'ZEYNEP GÜRKAN, Res. Asst.', 'role': 'CONTACT', 'email': 'zeynepgurkan@yyu.edu.tr', 'phone': '+905389786500'}], 'facility': 'Van Training and Research Hospital', 'geoPoint': {'lat': 38.49457, 'lon': 43.38323}}], 'centralContacts': [{'name': 'ZEYNEP GÜRKAN, Res. Asst.', 'role': 'CONTACT', 'email': 'zeynepgurkan@yyu.edu.tr', 'phone': '+905389786500'}], 'overallOfficials': [{'name': 'Zeynep Gürkan, Res. Asst.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yuzuncu Yil University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuzuncu Yil University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ataturk University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant and PhD Candidate', 'investigatorFullName': 'Zeynep Gürkan', 'investigatorAffiliation': 'Yuzuncu Yil University'}}}}