Pressure-sensing sheath monitoring during neuroendovascular procedures
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
Shanghai Fourth People's Hospital Tongji University · NCT07257367
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 |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Fourth People's Hospital Tongji University (other) |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07257367 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Blood Pressure Monitoring, Neuroendovascular Procedures, Pressure sensing sheath, Blood pressure monitoring, Invasive blood pressure, Neuroendovascular intervention