Pressure-sensing sheath monitoring during neuroendovascular procedures
Official title: Accuracy and Safety Assessment of Pressure Sensing Sheath Blood Pressure Monitoring Compared to Traditional Invasive and Non-invasive Blood Pressure Monitoring in Interventional Procedures: A Prospective, Single-Center, Self-Controlled Randomized Study
Run by Shanghai Fourth People's Hospital Tongji University · NCT07257367 · Data updated 2026-11-12
This study will see if a pressure-sensing sheath provides blood pressure readings that are as accurate and safe as a radial arterial line and a cuff for adults undergoing elective neuroendovascular procedures under general anesthesia.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Shanghai Fourth People's Hospital Tongji University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | May 31, 2027 |
| Registry record updated | July 14, 2026 |
| Trial ID | NCT07257367 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) scheduled for elective transradial neuroendovascular procedures under general anesthesia who require continuous invasive blood pressure monitoring and can give informed consent are ideal candidates.
✕Probably not a fit
Patients with contraindications to radial artery access, hemodynamic instability, severe coagulopathy, very high BMI, or those requiring postoperative continuous invasive monitoring are unlikely to receive benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-center observational study enrolling 50 adult patients undergoing elective transradial neuroendovascular procedures requiring continuous invasive blood pressure monitoring. Blood pressure will be recorded simultaneously using three methods during the procedure: a pressure-sensing sheath, a standard radial arterial line, and a non-invasive cuff. The primary outcome is the accuracy of the sheath measurements compared with the radial arterial line, with secondary outcomes including access site complications, procedure duration, patient comfort, and cost-effectiveness. Results will be analyzed to compare agreement between methods and to document safety and workflow implications.
Why it matters
Potential benefit: If successful, the pressure-sensing sheath could allow continuous arterial blood pressure monitoring without placing a separate radial arterial line, potentially reducing procedure time, patient discomfort, and arterial access complications.
How similar studies have gone: Prior small validation studies and device reports have shown promising agreement for intravascular pressure-sensing devices versus arterial lines, but evidence remains limited and not yet widely adopted.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Shanghai Fourth People's Hospital Tongji University
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Yibin Fang, MD, PhD
- Email: fangyibin@163.com
- Phone: +86 13585831041
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.