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:
Yuzuncu Yil University
Organization:
Study Overview
Official Title:
Development of an Arterial Pressure Monitoring Set Fixation Apparatus and Evaluation of Its Effectiveness
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
An 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.
Fixation 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.
Ethical approval has been obtained from the relevant institutional review board, and compliance with human subject protection standards will be maintained throughout the study.
An 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.
Fixation 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.
Ethical approval has been obtained from the relevant institutional review board, and compliance with human subject protection standards will be maintained throughout the study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| TDK-2024-14774 | OTHER_GRANT | Atatürk Univ. Sci. Res. Projects Coord. Unit | View |