Blood PressureNCT02357511
Validation of Pulse Waveform Analysis-based Continuous Noninvasive Blood Pressure Measurement Sensor
A study testing Study Monitor used in people with Blood Pressure, run by Tampere University Hospital at 1 site in Finland.
Trial summary
The study aims to define the sensitivity and specificity of a novel continuous noninvasive blood pressure monitor. 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?
- Study Monitor used
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2015to Jul 2015
- 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
- subjected to operative treatment with the need for invasive blood pressure measurement
- spontaneous ventilation
- able to give informed consent
Who cannot join
- denial by patient
- pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to define the sensitivity and specificity of a novel continuous noninvasive blood pressure monitor.
Read the detailed description
A novel continuous noninvasive blood pressure monitor is compared to invasive arterial measurement at postoperative care unit after a planned operation. Monitor captures also saturation and ECG, which are compared to traditional monitoring.
- Conditions
- Blood Pressure
- Being tested
- Study Monitor used
- Keywords
- sensitivity, specificity, novel blood pressure monitor, Saturation
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study Monitor usedDevice
| Study group | Role | What they receive |
|---|---|---|
| Study goup | Experimental | Vital values are being measured for the time of two hours at postoperative setting at postanesthesia care unit. A novel method is compared to golden standard: invasive measurement. Also Saturation measurements are being compared between standard and study monitor. Receives: Device: Study Monitor used |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between invasive and noninvasive blood pressure measurement
comparability of study monitor systolic, diastolic and mean blood pressure to invasive blood pressure measurement
Measured: 2 hours of continuous measurement at PACU
Secondary outcomes (1)
Relationship between study monitor Sp02 measurement and current sp02 measurement
comparability of measurements at several timepoints recorded as 10s intervals
Measured: 2 hours of continuous measurement at PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arvi Yli-Hankala, Professor, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357511
- Sponsor's protocol ID
- MEDIETA2015
- Status last verified
- Jul 2015
- First submitted
- 22 Jan 2015
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Pulse Waveform Analysis-based Continuous Noninvasive Blood Pressure Measurement Sensor
- ClinicalTrials.gov ID
- NCT02357511
- Acronym / sponsor ID
- MEDIETA2015
- Conditions
- Blood Pressure
- Keywords
- sensitivity, specificity, novel blood pressure monitor, Saturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 6 Feb 2015 (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.
The study aims to define the sensitivity and specificity of a novel continuous noninvasive blood pressure monitor.
Detailed description
A novel continuous noninvasive blood pressure monitor is compared to invasive arterial measurement at postoperative care unit after a planned operation. Monitor captures also saturation and ECG, which are compared to traditional monitoring.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study goup | Experimental | Device: Study Monitor usedVital values are being measured for the time of two hours at postoperative setting at postanesthesia care unit. A novel method is compared to golden standard: invasive measurement. Also Saturation measurements are being compared between standard and study monitor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subjected to operative treatment with the need for invasive blood pressure measurement
- spontaneous ventilation
- able to give informed consent
Key exclusion criteria (2 listed)
- denial by patient
- pacemaker
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 |
|---|---|---|
| Study Monitor used | Device | Study goup |
Primary outcome
Relationship between invasive and noninvasive blood pressure measurement
Time frame: 2 hours of continuous measurement at PACU
comparability of study monitor systolic, diastolic and mean blood pressure to invasive blood pressure measurement
1 secondary outcome
Relationship between study monitor Sp02 measurement and current sp02 measurement
Time frame: 2 hours of continuous measurement at PACU
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 29 Jul 2015.
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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.
Arvi Yli-Hankala, Professor principal investigator
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Monitor used in people with Blood Pressure, run by Tampere University Hospital at 1 site in Finland.
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 2 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 29 Jul 2015. 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 Finland. 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?
Relationship between invasive and noninvasive blood pressure measurement (time frame: 2 hours of continuous measurement at PACU). 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 29 Jul 2015.