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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

Eligibility

Primary outcome measure(s)

• Agreement of Mean Arterial Pressure Between Pressure Sensing Sheath and Radial Arterial Line — Intraoperative (duration of procedure, approximately 1-4 hours)
  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.

Trial sites (1)

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