Development of an Arterial Pressure Monitoring Set Fixation Apparatus

NCT ID: NCT07035756

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-27

Study Completion Date

2025-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Bypass Graft Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

The study is not blinded; participants and investigators know which intervention is used.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arterial Pressure Monitoring Set Fixation Device Group

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.

Group Type EXPERIMENTAL

Arterial Pressure Monitoring Set Fixation Device

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Arterial Pressure Monitoring Set Fixation 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ataturk University

OTHER

Sponsor Role collaborator

Yuzuncu Yıl University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zeynep Gürkan

Research Assistant and PhD Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zeynep Gürkan, Res. Asst.

Role: PRINCIPAL_INVESTIGATOR

Yuzuncu Yıl University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Van Training and Research Hospital

Van, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

ZEYNEP GÜRKAN, Res. Asst.

Role: CONTACT

+905389786500

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

ZEYNEP GÜRKAN, Res. Asst.

Role: primary

+905389786500

References

Explore related publications, articles, or registry entries linked to this study.

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/

Reference Type RESULT
PMID: 32310587 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TDK-2024-14774

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024/08-09

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.