Development of an Arterial Pressure Monitoring Set Fixation Apparatus

NCT07035756 | Recruiting

• 2 other identifiers: 2024/08-09TDK-2024-14774
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Bypass Graft Surgery

Keywords

Arterial Pressure Monitoring; Fixation Device; Coronary Artery Bypass Graft (CABG); Hemodynamic Monitoring; Postoperative Care

Outcome Measures

Primary Outcomes (1)

• Accuracy of Invasive Blood Pressure and Central Venous Pressure Measurements

  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.

  Within the first 48 hours of monitoring

Study Arms (1)

Arterial Pressure Monitoring Set Fixation Device Group

EXPERIMENTAL

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.

Device: Arterial Pressure Monitoring Set Fixation Device

Interventions

Arterial Pressure Monitoring Set Fixation Device DEVICE

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.

Arterial Pressure Monitoring Set Fixation Device Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuzuncu Yil University: lead
• Ataturk University: collaborator

Study Sites (1)

Van Training and Research Hospital

Van, 65000, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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/

  PMID: 32310587 RESULT

Study Officials

• Zeynep Gürkan, Res. Asst.

  Yuzuncu Yil University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ZEYNEP GÜRKAN, Res. Asst.

CONTACT

+905389786500; zeynepgurkan@yyu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The study is not blinded; participants and investigators know which intervention is used.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant and PhD Candidate

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 25, 2025
• Study Start: January 27, 2025
• Primary Completion: June 30, 2025
• Study Completion: October 31, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)