Arterial pressure line fixation device for CABG patients
Development of an Arterial Pressure Monitoring Set Fixation Apparatus and Evaluation of Its Effectiveness
NA · Yuzuncu Yil University · NCT07035756
We will test a new device that holds arterial pressure lines more securely and comfortably for adults after CABG surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Yuzuncu Yil University (other) |
| Locations | 1 site (Van) |
| Trial ID | NCT07035756 on ClinicalTrials.gov |
What this trial studies
The project develops and tests a novel fixation device intended to secure invasive arterial pressure monitoring sets and reduce discomfort after coronary artery bypass grafting. Sixty adult CABG patients who require postoperative arterial and central venous pressure monitoring will have the device applied. Fixation stability, patient comfort, and hemodynamic measures (arterial blood pressure and CVP) will be recorded over a 48-hour postoperative period and compared with standard adhesive tape fixation. The protocol has institutional ethical approval and follows standard human subject protections.
Who should consider this trial
Good fit: Adults aged 18–80 undergoing CABG who are hemodynamically stable, require invasive arterial and CVP monitoring, and can provide informed consent.
Not a fit: Patients who are hemodynamically unstable, have coagulopathy or local infection/skin lesions at the insertion site, a known allergy to device materials, or who are outside the 18–80 age range are unlikely to benefit.
Why it matters
Potential benefit: If successful, the device could reduce arterial line displacement and monitoring errors, improve patient comfort, and lower complications related to catheter movement.
How similar studies have performed: Some small prior studies of dedicated arterial line stabilizers have suggested improved line security and comfort, but this specific fixation apparatus is novel and not yet clinically validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients aged 18-80 years * Patients undergoing arterial catheterization for invasive blood pressure and CVP monitoring * Patients able to provide informed consent * Hemodynamically stable patients undergoing Coronary Artery Bypass Grafting (CABG) Exclusion Criteria: * Patients younger than 18 or older than 80 years * Patients with coagulopathy or bleeding disorders * Patients with local infection or skin lesions at the catheter insertion site * Patients unable to provide informed consent * Hemodynamically unstable patients * Patients with known allergy to device materials or adhesive tapes
Where this trial is running
Van
- Van Training and Research Hospital — Van, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: Zeynep Gürkan, Res. Asst. — Yuzuncu Yil University
- Study coordinator: ZEYNEP GÜRKAN, Res. Asst.
- Email: zeynepgurkan@yyu.edu.tr
- Phone: +905389786500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Artery Bypass Graft Surgery, Arterial Pressure Monitoring, Fixation Device, Coronary Artery Bypass Graft, Hemodynamic Monitoring, Postoperative Care