Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2021-09-14
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
ALL
No
Sponsors
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Taipei Medical University Hospital
OTHER
Cardio Ring Technologies, Inc. Taiwan Branch
INDUSTRY
Responsible Party
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Principal Investigators
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Chuen-Chau Chang, M.D,PhD.
Role: PRINCIPAL_INVESTIGATOR
Taipei Medical University Hospital
Locations
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Taipei Medical University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Chuen-Chau Chang, M.D,PhD
Role: primary
References
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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. No abstract available.
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.
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.
Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
Martina JR, Westerhof BE, van Goudoever J, de Beaumont EM, Truijen J, Kim YS, Immink RV, Jobsis DA, Hollmann MW, Lahpor JR, de Mol BA, van Lieshout JJ. Noninvasive continuous arterial blood pressure monitoring with Nexfin(R). Anesthesiology. 2012 May;116(5):1092-103. doi: 10.1097/ALN.0b013e31824f94ed.
Gratz I, Deal E, Spitz F, Baruch M, Allen IE, Seaman JE, Pukenas E, Jean S. Continuous Non-invasive finger cuff CareTaker(R) 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.
Gerlach G, Hofer HW. Interaction of immobilized phosphofructokinase with soluble muscle proteins. Biochim Biophys Acta. 1986 May 2;881(3):398-404. doi: 10.1016/0304-4165(86)90032-2.
Related Links
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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.
Other Identifiers
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N202106030
Identifier Type: -
Identifier Source: org_study_id