Intraoperative HypotensionNCT03795831
Validation Study in Patients of a Non-invasive Blood Pressure Monitor for Perioperative Use
An observational study of Intraoperative Hypotension, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Collecting all available data (waveforms, beat to beat data, status data) generated by a non invasive blood pressure monitor on each hand and compare this to the actual data obtained by intra arterial (radial) monitoring. This to see if the non invasive bloodpressure monitor can be validated for intraoperative use. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraoperative Hypotension
- What is being tested?
- ClearSight feasibility testing
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2017to 30 Dec 2019
- How long will I take part?
- 1 Day
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients in a perioperative setting already monitored with a system that accurately measures and stores the intra-arterial waveform, such as the FloTrac system in the EV1000 monitor.
Who may be able to join
- Patients whose arterial blood pressure is measured invasively with technology that allows for the storage of the intra-arterial waveform with sufficient quality and resolution (Flotrac).
- Patients older than 18, for elective general surgery.
Who cannot join
- Patient conditions that are expected to potentially and significantly affect the transfer of pressure between radial artery and the finger, e.g. due to recent finger fractures
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Academic Medical Center
Amsterdam, 1105AZ
D.P. Veelo, Dr., 0031205662533, d.p.veelo@amc.uva.nl
About this study
Collecting all available data (waveforms, beat to beat data, status data) generated by a non invasive blood pressure monitor on each hand and compare this to the actual data obtained by intra arterial (radial) monitoring.
This to see if the non invasive bloodpressure monitor can be validated for intraoperative use.
Read the detailed description
Although a blood pressure monitoring device could be evaluated by the comparing systolic, diastolic and mean arterial pressure to a reference pressure, it is the specific aim to collect all available data (waveforms, beat to beat data, status data) generated by the blood pressure monitor.
After data analysis and comparison to patient's actual intra-arterial waveform, the outcome will be evaluated by Association for the Advancement of Medical Instrumentation (AAMI) standards to see if the non invasive bloodpressure monitor can be validated for intraoperative use.
The study is targeted at patients already monitored with a system that accurately measures and stores the intra-arterial waveform, such as the FloTrac system in the EV1000 monitor.
This study is a substudy of a feasability protocol evaluating a new algorithm for the Clearsight system.
- Conditions
- Intraoperative Hypotension
- Being tested
- ClearSight feasibility testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClearSight feasibility testingDevice
A cuff is placed on a finger of the patient. The ClearSight system uses a volume clamp technology allowing measuring of continuous blood pressure waveform. Note: There will only be observational recordings, no interventions
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Adult patients, undergoing surgery requiring general anesthesia, planned to be monitored with a system that accurately measures and stores the intra-arterial waveform. Receives: Device: ClearSight feasibility testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
validation systole, diastole, mean ABP and pulse pressure
accuracy and precision of invasive blood pressure curve vs non-invasive blood pressure curves(ipsilateral and contralateral)
Measured: within 1 hour
implementation of software alterations to improve systole, diastole, mean ABP accuracy and pulse pressure
Comparison of the non-invasive blood pressure curve after software alterations to the reference and invasive arterial blood pressure curve
Measured: time during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start1 Mar 2017
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intraoperative HypotensionStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Principal investigator, D.P.Veelo, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- D.P. Veelo, Dr, Principal investigator, inverstigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795831
- Sponsor's protocol ID
- 2017-14
- Status last verified
- Jan 2019
- First submitted
- 4 Jan 2019
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Rellum SR, Noteboom SH, van der Ster BJP, Schuurmans J, Kho E, Vlaar APJ, Schenk J, Veelo DP. The hypotension prediction index versus mean arterial pressure in predicting intraoperative hypotension: A clinical perspective. Eur J Anaesthesiol. 2025 Jun 1;42(6):527-535. doi: 10.1097/EJA.0000000000002150. Epub 2025 Feb 27.
PubMed 40012367Rellum SR, Kho E, Schenk J, van der Ster BJP, Vlaar APJ, Veelo DP. A comparison between invasive and noninvasive measurement of the Hypotension Prediction Index: A post hoc analysis of a prospective cohort study. Eur J Anaesthesiol. 2025 Feb 1;42(2):131-139. doi: 10.1097/EJA.0000000000002082. Epub 2024 Oct 16.
PubMed 39411994Kho E, van der Ster BJP, van der Ven WH, Vlaar APJ, Immink RV, Veelo DP. Clinical agreement of a novel algorithm to estimate radial artery blood pressure from the non-invasive finger blood pressure. J Clin Anesth. 2022 Dec;83:110976. doi: 10.1016/j.jclinane.2022.110976. Epub 2022 Sep 26.
PubMed 36174389
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study in Patients of a Non-invasive Blood Pressure Monitor for Perioperative Use
- ClinicalTrials.gov ID
- NCT03795831
- Acronym / sponsor ID
- 2017-14
- Conditions
- Intraoperative Hypotension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 8 Jan 2019 (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.
Collecting all available data (waveforms, beat to beat data, status data) generated by a non invasive blood pressure monitor on each hand and compare this to the actual data obtained by intra arterial (radial) monitoring.
This to see if the non invasive bloodpressure monitor can be validated for intraoperative use.
Detailed description
Although a blood pressure monitoring device could be evaluated by the comparing systolic, diastolic and mean arterial pressure to a reference pressure, it is the specific aim to collect all available data (waveforms, beat to beat data, status data) generated by the blood pressure monitor.
After data analysis and comparison to patient's actual intra-arterial waveform, the outcome will be evaluated by Association for the Advancement of Medical Instrumentation (AAMI) standards to see if the non invasive bloodpressure monitor can be validated for intraoperative use.
The study is targeted at patients already monitored with a system that accurately measures and stores the intra-arterial waveform, such as the FloTrac system in the EV1000 monitor.
This study is a substudy of a feasability protocol evaluating a new algorithm for the Clearsight system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Device: ClearSight feasibility testingAdult patients, undergoing surgery requiring general anesthesia, planned to be monitored with a system that accurately measures and stores the intra-arterial waveform. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in a perioperative setting already monitored with a system that accurately measures and stores the intra-arterial waveform, such as the FloTrac system in the EV1000 monitor.
Key inclusion criteria (2 listed)
- Patients whose arterial blood pressure is measured invasively with technology that allows for the storage of the intra-arterial waveform with sufficient quality and resolution (Flotrac).
- Patients older than 18, for elective general surgery.
Key exclusion criteria (1 listed)
- Patient conditions that are expected to potentially and significantly affect the transfer of pressure between radial artery and the finger, e.g. due to recent finger fractures
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 |
|---|---|---|
| ClearSight feasibility testingA cuff is placed on a finger of the patient. The ClearSight system uses a volume clamp technology allowing measuring of continuous blood pressure waveform. Note: There will only be observational recordings, no interventions | Device | Cohort |
Primary outcome
validation systole, diastole, mean ABP and pulse pressure
Time frame: within 1 hour
accuracy and precision of invasive blood pressure curve vs non-invasive blood pressure curves(ipsilateral and contralateral)
implementation of software alterations to improve systole, diastole, mean ABP accuracy and pulse pressure
Time frame: time during surgery
Comparison of the non-invasive blood pressure curve after software alterations to the reference and invasive arterial blood pressure curve
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Derived from this study: PubMed 40012367Rellum SR, Noteboom SH, van der Ster BJP, Schuurmans J, Kho E, Vlaar APJ, Schenk J, Veelo DP. The hypotension prediction index versus mean arterial pressure in predicting intraoperative hypotension: A clinical perspective. Eur J Anaesthesiol. 2025 Jun 1;42(6):527-535. doi: 10.1097/EJA.0000000000002150. Epub 2025 Feb 27.
- Derived from this study: PubMed 39411994Rellum SR, Kho E, Schenk J, van der Ster BJP, Vlaar APJ, Veelo DP. A comparison between invasive and noninvasive measurement of the Hypotension Prediction Index: A post hoc analysis of a prospective cohort study. Eur J Anaesthesiol. 2025 Feb 1;42(2):131-139. doi: 10.1097/EJA.0000000000002082. Epub 2024 Oct 16.
- Derived from this study: PubMed 36174389Kho E, van der Ster BJP, van der Ven WH, Vlaar APJ, Immink RV, Veelo DP. Clinical agreement of a novel algorithm to estimate radial artery blood pressure from the non-invasive finger blood pressure. J Clin Anesth. 2022 Dec;83:110976. doi: 10.1016/j.jclinane.2022.110976. Epub 2022 Sep 26.
- Individual participant dataSharing planned: Undecided
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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.
D.P. Veelo, Dr principal investigator
inverstigator
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 Intraoperative Hypotension, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 2 inclusion and 1 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 10 Jan 2019. 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 Netherlands. 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 D.P. Veelo, Dr (0031205662533, d.p.veelo@amc.uva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
validation systole, diastole, mean ABP and pulse pressure (time frame: within 1 hour). The study lists 2 primary outcomes in all. 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 NCT03795831, which also lists 3 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 10 Jan 2019.