Coronary Artery Bypass Graft SurgeryNCT07035756
Development of an Arterial Pressure Monitoring Set Fixation Apparatus
A study testing Arterial Pressure Monitoring Set Fixation Device in people with Coronary Artery Bypass Graft Surgery, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Bypass Graft Surgery
- What is being tested?
- Arterial Pressure Monitoring Set Fixation Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jan 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of an Arterial Pressure Monitoring Set Fixation Apparatus and Evaluation of Its Effectiveness
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.
Read the 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.
- Conditions
- Coronary Artery Bypass Graft Surgery
- Being tested
- Arterial Pressure Monitoring Set Fixation Device
- Keywords
- Arterial Pressure Monitoring, Fixation Device, Coronary Artery Bypass Graft (CABG), Hemodynamic Monitoring, Postoperative Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial Pressure Monitoring Set Fixation DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Arterial Pressure Monitoring Set Fixation Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within the first 48 hours of monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start27 Jan 2025
- Primary completion30 Jun 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass Graft SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University
- Responsible party
- Principal investigator, Zeynep Gürkan, Yuzuncu Yil University
- Investigators
- Zeynep Gürkan, Res. Asst., Principal investigator, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035756
- Sponsor's protocol ID
- 2024/08-09
- Other IDs
- TDK-2024-14774
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Publications
Nguyen Y, Bora V. Arterial Pressure Monitoring. 2023 Mar 19. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK556127/
PubMed 32310587
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Arterial Pressure Monitoring Set Fixation Apparatus and Evaluation of Its Effectiveness
- ClinicalTrials.gov ID
- NCT07035756
- Acronym / sponsor ID
- 2024/08-09
- Conditions
- Coronary Artery Bypass Graft Surgery
- Keywords
- Arterial Pressure Monitoring, Fixation Device, Coronary Artery Bypass Graft (CABG), Hemodynamic Monitoring, Postoperative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Collaborators
- Ataturk University
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arterial Pressure Monitoring Set Fixation Device Group | Experimental | Device: Arterial Pressure Monitoring Set Fixation DeviceThis 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arterial Pressure Monitoring Set Fixation DeviceA 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. | Device | Arterial Pressure Monitoring Set Fixation Device Group |
Primary outcome
Accuracy of Invasive Blood Pressure and Central Venous Pressure Measurements
Time frame: Within the first 48 hours of monitoring
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Results publication: PubMed 32310587Nguyen Y, Bora V. Arterial Pressure Monitoring. 2023 Mar 19. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK556127/
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
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Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery
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Recruiting
Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery
Coronary Artery Disease With Need for Bypass Surgery, Coronary Artery Disease(CAD)
Active, not recruitingPhase 1
Comparison of Analgesic Efficacy Between Ultrasound Guided Serratus Anterior Plane Block or Thoracic Paravertebral Block Versus Intravenous Fentanyl for On-pump Coronary Artery Bypass Graft Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeynep Gürkan, Res. Asst. principal investigator
Yuzuncu Yil University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arterial Pressure Monitoring Set Fixation Device in people with Coronary Artery Bypass Graft Surgery, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Invasive Blood Pressure and Central Venous Pressure Measurements (time frame: Within the first 48 hours of monitoring). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07035756, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.