ArteVu Blood Pressure Accuracy Study

• Conditions: Blood Pressure
• Interventions: Device: ArteVu

• Registration Number: NCT05105204
• Lead Sponsor: Cardio Ring Technologies, Inc. Taiwan Branch

Brief Summary

A continuous noninvasive blood pressure monitoring digital fingertip clip device, the ArteVu, will be compared against the reference arterial catheter during operation. The device safety and its blood pressure accuracy will be examined in the study.

Detailed Description

ArteVu is a non-invasive and continuous blood pressure monitor. It detects the arterial pressure waveform with a force sensor that detects the arterial pulsation that produces changes in pressure transmitted through the subcutaneous tissue overlying or adjacent to the digital arteries. The data is transmitted to a parameter module to display noninvasive and continuous blood pressure in a hospital setting. The primary objective of this study is to validate ArteVu's blood pressure and heart rate measurement accuracy by comparing its values simultaneously with the corresponding values obtained from an invasive radial arterial line. The secondary objective is to evaluate the effectiveness of utilizing ArteVu for continuous blood pressure measurements. The study population includes 50 patients undergoing surgery who requires general anesthesia and continuous blood pressure measurement with a radial arterial line. Blood pressure values measured from the arterial line will be recorded simultaneously during ArteVu's measurements.

Study Timeline

• Study Start: 2021-09-14
• Status Verified: 2021-10
• Study First Submitted: 2021-10-04
• Study First Submitted QC: 2021-10-22
• Last Update Submitted: 2021-10-22
• Study First Posted: 2021-11-03
• Last Update Posted: 2021-11-03
• Primary Completion: 2022-03
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Age ≥ 20 years
2. Requiring general anesthesia and continuous blood pressure measurement with a radial arterial line
3. Limb circumference is within 22 cm - 32 cm
4. The width of the first knuckle of the index/middle/Ring finger is less than 19.8 mm
5. Ease of access to the finger and arm used for ArteVu
6. Able to provide written informed consent for participation in the study

Exclusion Criteria

1. Pregnant patients
2. Medical or surgical condition that prevents the ability to apply the ArteVu device on an upper extremity finger or the ipsilateral arm such as impaired skin integrity
3. Operations involving the upper extremities or the blood vessels of the upper extremities
4. Arthritis or severe deformities of the hand and fingers
5. Prosthetic devices or jewelry that cannot be removed from the finger or the ipsilateral arm to be used for the ArteVu device
6. History of malignant hyperthermia
7. Raynaud's disease affecting the fingers or hands
8. Topical allergy to Acrylonitrile Butadiene Styrene(ABS), Polycarbonate(PC), or silicone
9. Swelling, edema or lymphedema of the upper extremity
10. Participants with upper extremity occlusive peripheral vascular diseases
11. Inability of the patient to provide written informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Individuals need intra-arterial catheter at the radial artery for blood pressure monitoring	ArteVu	Individuals who requiring the use of intra-arterial catheter at the radial artery for continuous blood pressure monitoring for at least two hours as part of their planned care.

Primary Outcome Measures

Name	Time	Method
Blood pressure and heart rate measurement accuracy	around two hours.	To validate ArteVu's blood pressure and heart rate measurement accuracy by comparing its values simultaneously with the corresponding values obtained intra-arterially from an invasive radial arterial line, meeting a bias (as measured by overall mean difference) less than 5 mmHg and a standard deviation less than 8 mmHg for systolic and diastolic blood pressure. This accuracy satisfies the limits established for the validation of automatic blood pressure measurement according to the ANSI/AAMI/ISO 81060-2 standard.

Trial Locations

Locations (1)

Taipei Medical University Hospital; 🇨🇳 Taipei City, Taiwan