Clinical trial NCT05105204: ArteVu Blood Pressure Accuracy Study
Official title: ArteVu Blood Pressure Accuracy Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Pressure
Keywords: non-invasive blood pressure monitor
arterial waveform
Lead sponsor: Cardio Ring Technologies, Inc. Taiwan Branch
Sponsor class: INDUSTRY
Collaborators: name: Taipei Medical University Hospital
First posted: 2021-11-03
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient enrollment will continue until at least 30% are male; 30% are female; at least 40 % patients have a limb circumference that lies within the upper half of 22-32 cm; at least 40 % are within the lower half of 22-32 cm; in addition, 50 complete one-hour CNBP and NBP data sets are obtained. To assure that a sufficient range of blood pressure values are obtained, at least 10% of the measurements shall have invasive reference systolic blood pressure(SBP) lower or equal to 100 mmHg. At least 10% of the measurements shall have invasive reference SBP higher or equal to 160 mmHg. At least 10% of the measurements shall have invasive reference diastolic blood pressure(DBP) lower or equal to 70mmHg. At least 10% of the measurements shall have invasive reference DBP higher or equal to 85 mmHg.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood pressure and heart rate measurement accuracy
timeFrame: around two hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Taipei Medical University Hospital
Study officials:
affiliation: Taipei Medical University Hospital
name: Chuen-Chau Chang, M.D,PhD.
role: PRINCIPAL_INVESTIGATOR
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