ArteVu Blood Pressure Accuracy Study

Blood Pressure Clinical Trial

— ARTEVU  

Official title:

ArteVu Blood Pressure Accuracy Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05105204
• Other study ID #: N202106030
• Status: Recruiting
• Start date: September 14, 2021
• Est. completion date: June 2022

Study information

• Verified date: October 2021
• Source: Cardio Ring Technologies, Inc. Taiwan Branch
• Contact: Leng-Chun Chen, PhD
• Phone: +886933220322
• Email: rubychen[@]cardioring.co
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Device:
• ArteVu
The study participants will concurrently undergo noninvasive blood pressure monitoring with the ArteVu finger clip applied to the same extremity that is being used to measure the radial artery pressure.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Hospital	Taipei City

Sponsors (2)

Lead Sponsor	Collaborator
Cardio Ring Technologies, Inc. Taiwan Branch	Taipei Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (9)

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

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. — View Citation

Gerlach G, Hofer HW. Interaction of immobilized phosphofructokinase with soluble muscle proteins. Biochim Biophys Acta. 1986 May 2;881(3):398-404. — View Citation

Gratz I, Deal E, Spitz F, Baruch M, Allen IE, Seaman JE, Pukenas E, Jean S. Continuous Non-invasive finger cuff CareTaker® comparable to invasive intra-arterial pressure in patients undergoing major intra-abdominal surgery. BMC Anesthesiol. 2017 Mar 21;17(1):48. doi: 10.1186/s12871-017-0337-z. — View Citation

Hohn A, Defosse JM, Becker S, Steffen C, Wappler F, Sakka SG. Non-invasive continuous arterial pressure monitoring with Nexfin does not sufficiently replace invasive measurements in critically ill patients. Br J Anaesth. 2013 Aug;111(2):178-84. doi: 10.1093/bja/aet023. Epub 2013 Mar 13. — View Citation

Kim SH, Lilot M, Sidhu KS, Rinehart J, Yu Z, Canales C, Cannesson M. Accuracy and precision of continuous noninvasive arterial pressure monitoring compared with invasive arterial pressure: a systematic review and meta-analysis. Anesthesiology. 2014 May;120(5):1080-97. doi: 10.1097/ALN.0000000000000226. Review. — View Citation

Martina JR, Westerhof BE, van Goudoever J, de Beaumont EM, Truijen J, Kim YS, Immink RV, Jöbsis DA, Hollmann MW, Lahpor JR, de Mol BA, van Lieshout JJ. Noninvasive continuous arterial blood pressure monitoring with Nexfin®. Anesthesiology. 2012 May;116(5):1092-103. doi: 10.1097/ALN.0b013e31824f94ed. — View Citation

Stenglova A, Benes J. Continuous Non-Invasive Arterial Pressure Assessment during Surgery to Improve Outcome. Front Med (Lausanne). 2017 Nov 17;4:202. doi: 10.3389/fmed.2017.00202. eCollection 2017. Review. — View Citation

Williams JS, Brown SM, Conlin PR. Videos in clinical medicine. Blood-pressure measurement. N Engl J Med. 2009 Jan 29;360(5):e6. doi: 10.1056/NEJMvcm0800157. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure and heart rate measurement accuracy	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.	around two hours.

External Links

•   Association for the Advancement of Medical Instrumentation. Non-invasive sphygmomanometers-Part 2: Clinical investigation of intermittent automated measurement type. This is also a results reference.