Blood PressureARTEVUNCT05105204
ArteVu Blood Pressure Accuracy Study
An observational study of Blood Pressure, run by Cardio Ring Technologies, Inc. Taiwan Branch at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Blood Pressure
- What is being tested?
- ArteVu
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Sep 2021to Jun 2022
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age ≥ 20 years
- Requiring general anesthesia and continuous blood pressure measurement with a radial arterial line
- Limb circumference is within 22 cm - 32 cm
- The width of the first knuckle of the index/middle/Ring finger is less than 19.8 mm
- Ease of access to the finger and arm used for ArteVu
- Able to provide written informed consent for participation in the study
Who cannot join
- Pregnant patients
- 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
- Operations involving the upper extremities or the blood vessels of the upper extremities
- Arthritis or severe deformities of the hand and fingers
- Prosthetic devices or jewelry that cannot be removed from the finger or the ipsilateral arm to be used for the ArteVu device
- History of malignant hyperthermia
Show all 11Show fewer
- Raynaud's disease affecting the fingers or hands
- Topical allergy to Acrylonitrile Butadiene Styrene(ABS), Polycarbonate(PC), or silicone
- Swelling, edema or lymphedema of the upper extremity
- Participants with upper extremity occlusive peripheral vascular diseases
- Inability of the patient to provide written informed consent
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University Hospital
Taipei, 11031
Chuen-Chau Chang, M.D,PhD, +886227372181 ext. 8420, nekota@tmu.edu.tw
About this study
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.
Read the 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.
- Conditions
- Blood Pressure
- Being tested
- ArteVu
- Keywords
- non-invasive blood pressure monitor, arterial waveform
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArteVuDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ArteVu |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: around two hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start14 Sep 2021
- Primary completionMar 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Cardio Ring Technologies, Inc. Taiwan Branch
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Taipei Medical University Hospital
- Responsible party
- Sponsor
- Investigators
- Chuen-Chau Chang, M.D,PhD., Principal investigator, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105204
- Sponsor's protocol ID
- N202106030
- Acronym
- ARTEVU
- Status last verified
- Oct 2021
- First submitted
- 4 Oct 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD (study protocol and analytic code) that underlines the results reported in a further publication article, after de-identification.
Publications
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.
PubMed 19179309Stenglova 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.
PubMed 29204425Froehler 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.
PubMed 29487193Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
PubMed 2868172Martina 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.
PubMed 22415387Gratz 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.
PubMed 28327093Hohn 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.
PubMed 23485882Kim 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.
PubMed 24637618Gerlach 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.
PubMed 2938635
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ArteVu Blood Pressure Accuracy Study
- ClinicalTrials.gov ID
- NCT05105204
- Acronym / sponsor ID
- ARTEVU / N202106030
- Conditions
- Blood Pressure
- Keywords
- non-invasive blood pressure monitor, arterial waveform
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cardio Ring Technologies, Inc. Taiwan BranchIndustry (pharma, biotech, devices)
- Collaborators
- Taipei Medical University Hospital
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals need intra-arterial catheter at the radial artery for blood pressure monitoring | – | Device: ArteVuIndividuals 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Age ≥ 20 years
- Requiring general anesthesia and continuous blood pressure measurement with a radial arterial line
- Limb circumference is within 22 cm - 32 cm
- The width of the first knuckle of the index/middle/Ring finger is less than 19.8 mm
- Ease of access to the finger and arm used for ArteVu
Key exclusion criteria (11 listed)
- Pregnant patients
- 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
- Operations involving the upper extremities or the blood vessels of the upper extremities
- Arthritis or severe deformities of the hand and fingers
- Prosthetic devices or jewelry that cannot be removed from the finger or the ipsilateral arm to be used for the ArteVu device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArteVuThe 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. | Device | Individuals need intra-arterial catheter at the radial artery for blood pressure monitoring |
Primary outcome
Blood pressure and heart rate measurement accuracy
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Background: PubMed 19179309Williams 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.
- Background: PubMed 29204425Stenglova 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.
- Background: PubMed 29487193Froehler 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.
- Background: PubMed 2868172Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
- Background: PubMed 22415387Martina 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.
- Background: PubMed 28327093Gratz 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.
- Background: PubMed 23485882Hohn 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.
- Background: PubMed 24637618Kim 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.
- Results publication: PubMed 2938635Gerlach 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.
- Individual participant dataSharing planned: Yes. IPD (study protocol and analytic code) that underlines the results reported in a further publication article, after de-identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chuen-Chau Chang, M.D,PhD. principal investigator
Taipei Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by Cardio Ring Technologies, Inc. Taiwan Branch at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leng-Chun Chen, PhD (+886933220322, rubychen@cardioring.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure and heart rate measurement accuracy (time frame: around two hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05105204, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.