Blood PressureBPNCT02651558
Optical System to Continuously Measure Arterial Blood Pressure
A study testing Experimental: OBPM 2015-MD-0022 - CHEST, Experimental: OBPM 2015-MD-0022 - CHEST & FINGER and Experimental: OBPM 2015-MD-0022 - FINGER in people with Blood Pressure, run by CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement at 1 site in Switzerland.
Trial summary
Comparison of an optical method to continuously measure blood pressure against an invasive arterial catheter. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Experimental: OBPM 2015-MD-0022 - CHEST, Experimental: OBPM 2015-MD-0022 - CHEST & FINGER and Experimental: OBPM 2015-MD-0022 - FINGER
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2016to 1 Nov 2017
- Phase
- Interventional
- 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
Who may be able to join
- patient requiring the placement of an arterial catheter for general anesthesia
- minimum of 18 years
- written consent
Who cannot join
- minor patient or incapable of discernment
- patient with AIMD
- thoracic surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of an Optical System to Continuously Measure Arterial Blood Pressure Against a Gold-standard Arterial Catheter
Comparison of an optical method to continuously measure blood pressure against an invasive arterial catheter.
Read the detailed description
The measurement of blood pressure during anesthesia is commonly performed by the inflation of a brachial cuff providing only intermittent blood pressure measurements. In some case, it is required to add a continuous invasive monitoring of blood pressure, via the insertion of an arterial catheter. Unfortunately, the related morbidity is not negligible. To limit the consequences of such a gesture, some developments have been done in the past to allow for continuous non-invasive measurements of blood pressure during anesthesia. Unfortunately, most of these devices are subject to important limitations and constraints of use.
A new system has been designed by CSEM consisting of an optical system fixed on patient's skin, absolutely non-invasive and easy to use. In order to study the reliability of this device, the investigators plan to compare its blood pressure estimates against gold-standard arterial catheter measurements during induction of general anesthesia on:
- 40 patients wearing the optical system at the chest.
- and 40 patients wearing the optical system at the fingertip
- Conditions
- Blood Pressure
- Being tested
- Experimental: OBPM 2015-MD-0022 - CHEST, Experimental: OBPM 2015-MD-0022 - CHEST & FINGER, Experimental: OBPM 2015-MD-0022 - FINGER
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: OBPM 2015-MD-0022 - CHESTDevice
At the onset of general anesthesia:
- continuous measurements of radial arterial blood pressure values (arterial catheter, via a commercial PHILIPS IntelliVue MP50 monitor)
- continuous estimates of optical blood pressure values at the chest (optical blood pressure system, via Swissmedic approved OBPM measuring device 2015-MD-0022 developed by CSEM) will be recorded.
Experimental: OBPM 2015-MD-0022 - CHEST & FINGERDevice
At the onset of general anesthesia:
- continuous measurements of radial arterial blood pressure values (arterial catheter, via a commercial PHILIPS IntelliVue MP50 monitor)
- continuous estimates of optical blood pressure values at the chest (optical blood pressure system, via Swissmedic approved OBPM measuring device 2015-MD-0022 developed by CSEM)
- continuous estimates of optical blood pressure values at the fingertip (optical blood pressure system, via Swissmedic approved OBPM measuring device 2015-MD-0022 developed by CSEM) will be recorded.
Experimental: OBPM 2015-MD-0022 - FINGERDevice
At the onset of general anesthesia:
- continuous measurements of radial arterial blood pressure values (arterial catheter, via a commercial PHILIPS IntelliVue MP50 monitor)
- continuous estimates of optical blood pressure values at the fingertip (optical blood pressure system, via Swissmedic approved OBPM measuring device 2015-MD-0022 developed by CSEM) will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| OBPM 2015-MD-0022 - CHEST | Experimental | Cohort of 30 patients undergoing general anesthesia, monitored by optical signals at the chest Receives: Device: Experimental: OBPM 2015-MD-0022 - CHEST |
| OBPM 2015-MD-0022 - CHEST & FINGER | Experimental | Cohort of 10 patients undergoing general anesthesia, monitored by optical signals at the chest and at the fingertip Receives: Device: Experimental: OBPM 2015-MD-0022 - CHEST & FINGER |
| OBPM 2015-MD-0022 - FINGER | Experimental | Cohort of 30 patients undergoing general anesthesia, monitored by optical signals at the fingertip Receives: Device: Experimental: OBPM 2015-MD-0022 - FINGER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Error (in mmHg) between paired determinations of arterial blood pressure from an optical device against reference measurements from an arterial catheter
The signals recorded by the optical blood pressure device will be retrospectively analysed (offline analysis) in order to test the hypothesis that blood pressure values as derived by the new device is comparable to blood pressure values as measured by an arterial catheter within the limits of agreement in mmHg stated by ISO 81060-2 2013.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study startApr 2016
- Primary completion1 Nov 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier Universitaire Vaudois
- Responsible party
- Sponsor
- Investigators
- Patrick Schoettker, Principal investigator, CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651558
- Sponsor's protocol ID
- BLOOD PRESSURE
- Acronym
- BP
- Status last verified
- Apr 2018
- First submitted
- 17 Dec 2015
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Ghamri Y, Proenca M, Hofmann G, Renevey P, Bonnier G, Braun F, Axis A, Lemay M, Schoettker P. Automated Pulse Oximeter Waveform Analysis to Track Changes in Blood Pressure During Anesthesia Induction: A Proof-of-Concept Study. Anesth Analg. 2020 May;130(5):1222-1233. doi: 10.1213/ANE.0000000000004678.
PubMed 32287129
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of an Optical System to Continuously Measure Arterial Blood Pressure Against a Gold-standard Arterial Catheter
- ClinicalTrials.gov ID
- NCT02651558
- Acronym / sponsor ID
- BP / BLOOD PRESSURE
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et DeveloppementIndustry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier Universitaire Vaudois
- Study start
- Apr 2016 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 11 Jan 2016 (estimated)
- 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.
Comparison of an optical method to continuously measure blood pressure against an invasive arterial catheter.
Detailed description
The measurement of blood pressure during anesthesia is commonly performed by the inflation of a brachial cuff providing only intermittent blood pressure measurements. In some case, it is required to add a continuous invasive monitoring of blood pressure, via the insertion of an arterial catheter. Unfortunately, the related morbidity is not negligible. To limit the consequences of such a gesture, some developments have been done in the past to allow for continuous non-invasive measurements of blood pressure during anesthesia. Unfortunately, most of these devices are subject to important limitations and constraints of use.
A new system has been designed by CSEM consisting of an optical system fixed on patient's skin, absolutely non-invasive and easy to use. In order to study the reliability of this device, the investigators plan to compare its blood pressure estimates against gold-standard arterial catheter measurements during induction of general anesthesia on:
- 40 patients wearing the optical system at the chest.
- and 40 patients wearing the optical system at the fingertip
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OBPM 2015-MD-0022 - CHEST | Experimental | Device: Experimental: OBPM 2015-MD-0022 - CHESTCohort of 30 patients undergoing general anesthesia, monitored by optical signals at the chest |
| OBPM 2015-MD-0022 - CHEST & FINGER | Experimental | Device: Experimental: OBPM 2015-MD-0022 - CHEST & FINGERCohort of 10 patients undergoing general anesthesia, monitored by optical signals at the chest and at the fingertip |
| OBPM 2015-MD-0022 - FINGER | Experimental | Device: Experimental: OBPM 2015-MD-0022 - FINGERCohort of 30 patients undergoing general anesthesia, monitored by optical signals at the fingertip |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient requiring the placement of an arterial catheter for general anesthesia
- minimum of 18 years
- written consent
Key exclusion criteria (3 listed)
- minor patient or incapable of discernment
- patient with AIMD
- thoracic surgery
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 |
|---|---|---|
| Experimental: OBPM 2015-MD-0022 - CHESTAt the onset of general anesthesia: 1. continuous measurements of radial arterial blood pressure values (arterial catheter, via a commercial PHILIPS IntelliVue MP50 monitor) 2. continuous estimates of optical blood pressure values at the chest (optical blood pressure system, via Swissmedic approved OBPM measuring device 2015-MD-0022 developed by CSEM) will be recorded. | Device | OBPM 2015-MD-0022 - CHEST |
| Experimental: OBPM 2015-MD-0022 - CHEST & FINGERAt the onset of general anesthesia: 1. continuous measurements of radial arterial blood pressure values (arterial catheter, via a commercial PHILIPS IntelliVue MP50 monitor) 2. continuous estimates of optical blood pressure values at the chest (optical blood pressure system, via Swissmedic approved OBPM measuring device 2015-MD-0022 developed by CSEM) 3. continuous estimates of optical blood pressure values at the fingertip (optical blood pressure system, via Swissmedic approved OBPM measuring device 2015-MD-0022 developed by CSEM) will be recorded. | Device | OBPM 2015-MD-0022 - CHEST & FINGER |
| Experimental: OBPM 2015-MD-0022 - FINGERAt the onset of general anesthesia: 1. continuous measurements of radial arterial blood pressure values (arterial catheter, via a commercial PHILIPS IntelliVue MP50 monitor) 2. continuous estimates of optical blood pressure values at the fingertip (optical blood pressure system, via Swissmedic approved OBPM measuring device 2015-MD-0022 developed by CSEM) will be recorded. | Device | OBPM 2015-MD-0022 - FINGER |
Primary outcome
Error (in mmHg) between paired determinations of arterial blood pressure from an optical device against reference measurements from an arterial catheter
Time frame: 24 months
The signals recorded by the optical blood pressure device will be retrospectively analysed (offline analysis) in order to test the hypothesis that blood pressure values as derived by the new device is comparable to blood pressure values as measured by an arterial catheter within the limits of agreement in mmHg stated by ISO 81060-2 2013.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
- Derived from this study: PubMed 32287129Ghamri Y, Proenca M, Hofmann G, Renevey P, Bonnier G, Braun F, Axis A, Lemay M, Schoettker P. Automated Pulse Oximeter Waveform Analysis to Track Changes in Blood Pressure During Anesthesia Induction: A Proof-of-Concept Study. Anesth Analg. 2020 May;130(5):1222-1233. doi: 10.1213/ANE.0000000000004678.
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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.
Patrick Schoettker principal investigator
CHUV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: OBPM 2015-MD-0022 - CHEST, Experimental: OBPM 2015-MD-0022 - CHEST & FINGER and Experimental: OBPM 2015-MD-0022 - FINGER in people with Blood Pressure, run by CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement at 1 site in Switzerland.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 12 Apr 2018. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Error (in mmHg) between paired determinations of arterial blood pressure from an optical device against reference measurements from an arterial catheter (time frame: 24 months). 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 NCT02651558, which also lists 1 linked publication.
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 12 Apr 2018; AzTrials last refreshed its copy on 6 Nov 2026.