ARTEVU: ArteVu Blood Pressure Accuracy Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Individuals need intra-arterial catheter at the radial artery for blood pressure monitoring 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. |
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.
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Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 20 years
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Requiring general anesthesia and continuous blood pressure measurement with a radial arterial line
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Limb circumference is within 22 cm - 32 cm
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The width of the first knuckle of the index/middle/Ring finger is less than 19.8 mm
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Ease of access to the finger and arm used for ArteVu
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Able to provide written informed consent for participation in the study
Exclusion Criteria:
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Pregnant patients
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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
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Operations involving the upper extremities or the blood vessels of the upper extremities
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Arthritis or severe deformities of the hand and fingers
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Prosthetic devices or jewelry that cannot be removed from the finger or the ipsilateral arm to be used for the ArteVu device
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History of malignant hyperthermia
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Raynaud's disease affecting the fingers or hands
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Topical allergy to Acrylonitrile Butadiene Styrene(ABS), Polycarbonate(PC), or silicone
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Swelling, edema or lymphedema of the upper extremity
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Participants with upper extremity occlusive peripheral vascular diseases
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Inability of the patient to provide written informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Taipei Medical University Hospital | Taipei City | Taiwan | 11031 |
Sponsors and Collaborators
- Cardio Ring Technologies, Inc. Taiwan Branch
- Taipei Medical University Hospital
Investigators
- Principal Investigator: Chuen-Chau Chang, M.D,PhD., Taipei Medical University Hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- N202106030