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Recruiting NCT07257367

NCT07257367 Pressure Sensing Sheath Blood Pressure Monitoring Compared to Traditional Methods in Interventional Procedures

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Clinical Trial Summary
NCT ID NCT07257367
Status Recruiting
Phase
Sponsor Shanghai Fourth People's Hospital Tongji University
Condition Blood Pressure Monitoring
Study Type OBSERVATIONAL
Enrollment 50 participants
Start Date 2025-08-01
Primary Completion 2026-12-31

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL
Interventions
Pressure Sensing Sheath MonitoringRadial Arterial Line Monitoring

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 50 participants in total. It began in 2025-08-01 with a primary completion date of 2026-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

This observational study aims to evaluate the accuracy and safety of pressure sensing sheath blood pressure monitoring compared to traditional invasive and non-invasive blood pressure monitoring methods during neuroendovascular interventional procedures. The study will enroll 50 adult patients undergoing elective neuroendovascular procedures requiring general anesthesia and continuous invasive blood pressure monitoring. Blood pressure will be simultaneously measured using three methods: (1) pressure sensing sheath, (2) radial arterial line, and (3) non-invasive cuff monitoring. The primary outcome is the accuracy of blood pressure measurements from the pressure sensing sheath compared to radial arterial line measurements. Secondary outcomes include the incidence of access site complications, procedure duration, patient comfort scores, and cost-effectiveness analysis. This prospective, single-center study will be conducted at Shanghai Fourth People's Hospital Affiliated to Tongji University from August 2025 to May 2027.

Eligibility Criteria

Inclusion Criteria: * Age ≥18 years * Patients scheduled for elective transradial interventional procedures requiring continuous invasive blood pressure monitoring * Patients who must undergo radial arterial catheterization for invasive blood pressure monitoring according to clinical needs and standard medical operational procedures * Patients who can understand the study purpose, voluntarily participate and sign informed consent, and are willing to undergo relevant examinations and clinical follow-up Exclusion Criteria: * Contraindications to radial artery access * Hemodynamic instability * Patients requiring postoperative continuous invasive blood pressure monitoring * Failure to obtain informed consent * Known severe aortic or subclavian artery stenosis or occlusion * Severe coagulation dysfunction (INR ≥2.0, platelet count \<75×10⁹/L) * BMI \>40 kg/m² * Severe heart failure (NYHA Class IV) or patients requiring emergency rescue with hemodynamic instability

Contact & Investigator

Central Contact

Yibin Fang, MD, PhD

✉ fangyibin@163.com

📞 +86 13585831041

Frequently Asked Questions

Who can join the NCT07257367 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Blood Pressure Monitoring. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07257367 currently recruiting?

Yes, NCT07257367 is actively recruiting participants. Contact the research team at fangyibin@163.com for enrollment information.

Where is the NCT07257367 trial being conducted?

This trial is being conducted at Shanghai, China.

Who is sponsoring the NCT07257367 clinical trial?

NCT07257367 is sponsored by Shanghai Fourth People's Hospital Tongji University. The trial plans to enroll 50 participants.

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