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

NCT07257367 | Recruiting

• 2 other identifiers: ENDO TSP-BP2025110-002
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure Monitoring; Neuroendovascular Procedures

Keywords

Pressure sensing sheath; Blood pressure monitoring; Invasive blood pressure; Neuroendovascular intervention

Outcome Measures

Primary Outcomes (1)

• Agreement of Mean Arterial Pressure Between Pressure Sensing Sheath and Radial Arterial Line

  Agreement analysis of mean arterial pressure (MAP) measurements between pressure sensing sheath monitoring and radial arterial line monitoring using Bland-Altman method. Non-inferiority criterion: 95% limits of agreement within ±10 mmHg. Synchronous comparison of both methods in the same patient to eliminate individual differences.

  Intraoperative (duration of procedure, approximately 1-4 hours)

Secondary Outcomes (4)

• Agreement of Systolic and Diastolic Blood Pressure

  Intraoperative (duration of procedure, approximately 1-4 hours)

• Procedural Efficiency

  From patient entry to operating room until completion of procedure setup (approximately 10-30 minutes)

• Incidence of Access Site Complications

  From procedure start through 7 days post-procedure

• Patient-Reported Puncture Site Pain Score

  24 hours and 7 days post-procedure

Study Arms (1)

All Participants

All enrolled patients will receive simultaneous blood pressure monitoring using both methods: (1) Pressure sensing sheath monitoring system inserted via radial artery, and (2) Traditional radial arterial line monitoring on the contralateral side combined with standard non-invasive blood pressure cuff monitoring. This is a self-controlled study design where each patient serves as their own control.

Device: Pressure Sensing Sheath Monitoring; Device: Radial Arterial Line Monitoring

Interventions

Pressure Sensing Sheath Monitoring DEVICE

Continuous invasive blood pressure monitoring via pressure sensing sheath inserted through radial artery during interventional procedure. The pressure sensing sheath integrates a miniature pressure sensor within the vascular access sheath, enabling simultaneous vascular access and continuous blood pressure monitoring.

All Participants

Radial Arterial Line Monitoring DEVICE

Traditional invasive blood pressure monitoring via radial arterial catheterization (RAC) on the contralateral radial artery, combined with standard non-invasive blood pressure cuff monitoring. This serves as the gold standard comparator for blood pressure measurement accuracy.

All Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) undergoing elective neuroendovascular interventional procedures requiring general anesthesia and continuous invasive blood pressure monitoring at Shanghai Fourth People's Hospital Affiliated to Tongji University. Target enrollment is 50 patients from September 2025 to December 2026.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Fourth People's Hospital Tongji University: lead

Study Sites (1)

Shanghai Fourth People's Hospital Tongji University

Shanghai, Shanghai Municipality, China

RECRUITING

Related Publications (5)

• Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019 Dec;50(12):e344-e418. doi: 10.1161/STR.0000000000000211. Epub 2019 Oct 30.

  PMID: 31662037 RESULT

• Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.

  PMID: 2868172 RESULT

• Rashid M, Kwok CS, Pancholy S, Chugh S, Kedev SA, Bernat I, Ratib K, Large A, Fraser D, Nolan J, Mamas MA. Radial Artery Occlusion After Transradial Interventions: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2016 Jan 25;5(1):e002686. doi: 10.1161/JAHA.115.002686.

  PMID: 26811162 RESULT

• Froehler MT, Chitale R, Magarik JA, Fusco MR. Comparison of a pressure-sensing sheath and radial arterial line for intraoperative blood pressure monitoring in neurointerventional procedures. J Neurointerv Surg. 2018 Aug;10(8):784-787. doi: 10.1136/neurintsurg-2018-013769. Epub 2018 Feb 27.

  PMID: 29487193 RESULT

• Purdy PD, South C, Klucznik RP, Liu KC, Novakovic RL, Puri AS, Pride GL, Aagaard-Kienitz B, Ray A, Elliott AC. Use of a pressure sensing sheath: comparison with standard means of blood pressure monitoring in catheterization procedures. J Neurointerv Surg. 2017 Aug;9(8):766-771. doi: 10.1136/neurintsurg-2016-012536. Epub 2016 Jul 15.

  PMID: 27422970 RESULT

Central Study Contacts

Yibin Fang, MD, PhD

CONTACT

+86 13585831041; fangyibin@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 2, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)