Systemic HypertensionIMPACTNCT03710473
Non-Invasive Blood Pressure Measurement in Critically Ill PAtients Post Cardiosurgical Therapy
An observational study of Systemic Hypertension, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The aim of the present study is to evaluate the accuracy of measuring beat-by-beat diastolic blood pressure from a non-invasive, cuffless and non-obtrusive watch-like optical device worn at the wrist. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Hypertension
- What is being tested?
- Optical sensor, Pulse watch
- How many people
- 90 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2019to 15 Jan 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients scheduled for cardiac or vascular surgery at the Department of Cardiovascular Surgery of Inselspital, Bern.
Who may be able to join
- Scheduled for cardiac or vascular surgery, with presence of a radial arterial line for perioperative management;
- Willing and able to provide Informed Consent.
Who cannot join
- (Chronic) pace-maker/ defibrillator in situ at study inclusion;
- Known severe aortic stenosis (mean gradient > 40 mmHg, valve area < 1 cm2);
- Rhythmogenic heart disease (resting heart rate > 120/min) at time of study inclusion;
- Emergency patient (i.e. unscheduled OR).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive and Continuous Monitoring of Diastolic Blood Pressure: a Prospective Observational Study - IMPACT
The aim of the present study is to evaluate the accuracy of measuring beat-by-beat diastolic blood pressure from a non-invasive, cuffless and non-obtrusive watch-like optical device worn at the wrist.
Read the detailed description
Given the prevalence of hypertension in society and the current limitations associated with oscillometric cuffs, the need for a continuous cuffless alternative for blood pressure home monitoring at a global scale is paramount. Such a device would not only improve the global control of blood pressure, but more generally, it could have a larger social impact by improving the comfort and reducing the stress for the clinical management of hypertensive patients.
In the present study the investigators seek to investigate, as a primary purpose, to evaluate the accuracy of non-invasive blood pressure measurements via a watch-like optical sensor and compare these to standard monitoring (arterial line).
- Conditions
- Systemic Hypertension
- Being tested
- Optical sensor, Pulse watch
- Keywords
- Hypertension, Non-invasive blood pressure Monitoring, Photoplethysmography
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical sensor, Pulse watchDiagnostic test
Continuous blood pressure monitoring obtained by a Pulse watch
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of diastolic blood pressures (in mmHg) assessed via non-invasive vs. invasive blood pressure (arterial line) measurement
Statistical comparison of both measures of diastolic blood pressure
Measured: 24 hours
Secondary outcomes (2)
Descriptive assessment: time until normalization of measurement after re-calibration of diastolic blood pressure measurement using the non-invasive approach
To evaluate the influence of the re-calibration time interval (amount of time in-between two consecutive calibrations of the optical devices) on the accuracy of diastolic blood pressure assessment.
Measured: 24 hours
Descriptive analysis of comparison to measurements at the fingertip (non-invasive vs. fingertip diastolic blood pressure assessment)
To compare the accuracy when applied to photoplethysmographic signals measured at the wrist versus signals measured at the fingertip.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start1 Apr 2019
- Primary completion30 Dec 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic HypertensionStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Ava AG, CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
- Responsible party
- Sponsor
- Investigators
- David Reineke, MD, Principal investigator, Dept of Cardiovascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710473
- Sponsor's protocol ID
- HOPE CT 1
- Acronym
- IMPACT
- Status last verified
- Nov 2024
- First submitted
- 11 Oct 2018
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive and Continuous Monitoring of Diastolic Blood Pressure: a Prospective Observational Study - IMPACT
- ClinicalTrials.gov ID
- NCT03710473
- Acronym / sponsor ID
- IMPACT / HOPE CT 1
- Conditions
- Systemic Hypertension
- Keywords
- Hypertension, Non-invasive blood pressure Monitoring, Photoplethysmography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Ava AG, CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 18 Oct 2018 (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.
The aim of the present study is to evaluate the accuracy of measuring beat-by-beat diastolic blood pressure from a non-invasive, cuffless and non-obtrusive watch-like optical device worn at the wrist.
Detailed description
Given the prevalence of hypertension in society and the current limitations associated with oscillometric cuffs, the need for a continuous cuffless alternative for blood pressure home monitoring at a global scale is paramount. Such a device would not only improve the global control of blood pressure, but more generally, it could have a larger social impact by improving the comfort and reducing the stress for the clinical management of hypertensive patients.
In the present study the investigators seek to investigate, as a primary purpose, to evaluate the accuracy of non-invasive blood pressure measurements via a watch-like optical sensor and compare these to standard monitoring (arterial line).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients scheduled for cardiac or vascular surgery at the Department of Cardiovascular Surgery of Inselspital, Bern.
Key inclusion criteria (2 listed)
- Scheduled for cardiac or vascular surgery, with presence of a radial arterial line for perioperative management;
- Willing and able to provide Informed Consent.
Key exclusion criteria (4 listed)
- (Chronic) pace-maker/ defibrillator in situ at study inclusion;
- Known severe aortic stenosis (mean gradient > 40 mmHg, valve area < 1 cm2);
- Rhythmogenic heart disease (resting heart rate > 120/min) at time of study inclusion;
- Emergency patient (i.e. unscheduled OR).
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 |
|---|---|---|
| Optical sensor, Pulse watchContinuous blood pressure monitoring obtained by a Pulse watch | Diagnostic test | – |
Primary outcome
Comparison of diastolic blood pressures (in mmHg) assessed via non-invasive vs. invasive blood pressure (arterial line) measurement
Time frame: 24 hours
Statistical comparison of both measures of diastolic blood pressure
2 secondary outcomes
Descriptive assessment: time until normalization of measurement after re-calibration of diastolic blood pressure measurement using the non-invasive approach
Time frame: 24 hours
Descriptive analysis of comparison to measurements at the fingertip (non-invasive vs. fingertip diastolic blood pressure assessment)
Time frame: 24 hours
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 Nov 2024.
- Individual participant dataSharing planned: No
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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.
David Reineke, MD principal investigator
Dept of Cardiovascular Surgery
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 Systemic Hypertension, run by Insel Gruppe AG, University Hospital Bern 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 2 inclusion and 4 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 Nov 2024. 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?
Comparison of diastolic blood pressures (in mmHg) assessed via non-invasive vs. invasive blood pressure (arterial line) measurement (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2024.