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

NCT07257367 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2025-12-02

No results posted yet for this study

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

Interventions

DEVICE

Pressure Sensing Sheath Monitoring

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.

DEVICE

Radial Arterial Line Monitoring

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.

Sponsors & Collaborators

  • Shanghai Fourth People's Hospital Tongji University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2026-12-31
Completion
2027-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07257367 on ClinicalTrials.gov