BloodpressureNCT02038270
Accuracy of Nexfin® and NIBP to Predict IBP
An observational study of Bloodpressure, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The Nexfin monitoring device relies on noninvasive pressure measurement using a finger-cuff manometer, combined with NIRS technology. The accuracy of the signal is dependent on the degree of vascular unloading, which takes an period before optimal unloading is reached. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bloodpressure
- How many people
- 110 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2011to Mar 2012
- 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: 120 Adult patients, that are having a routine surgical procedure.
Who may be able to join
- Patients that are accepted for surgery
Who cannot join
- Patients unable or unwilling to provide consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evolution of the Accuracy of the Nexfin Pressure Signal Compared to Invasive and Noninvasive Arterial Blood Pressure
The Nexfin monitoring device relies on noninvasive pressure measurement using a finger-cuff manometer, combined with NIRS technology. The accuracy of the signal is dependent on the degree of vascular unloading, which takes an period before optimal unloading is reached. The evolution of the degree of inaccuracy caused by inclomplete unloading is quantified, and the absolute and relative inaccuracy of the nexfin as a function of the time is determined compared to the invasive blood pressure (IBP).
Secondly, the accuracy of the Nexfin to predict the IBP is compared with the accuracy of noninvasive blood pressure to predict the IBP.
Read the detailed description
In patients under stable anesthesia conditions, who have IBP and NIBP monitoring, the Nexfin will additionaly be connected. All data will be recorded for at least 30 minutes. NIBP will be measured every 5 minutes The evolution of the NIBP, IBP and Nexfin-derived blood pressure will be analysed to determine the evolution of inaccuracy due to incomplete vascular unloading and to determine the accuracy of Nexfin compared with NIBP to determine IBP.
- Conditions
- Bloodpressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| surgical patients | 120 Adult patients, that are having a routine surgical procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
vascular unloading time
time to optimal vascular unloading
Measured: Start till end of operation
Secondary outcomes (1)
Bloodpressure
accuracy of nexfin compared to NIBP and IBP
Measured: Start till end of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startSep 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BloodpressureStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain Kalmar, dr, Principal investigator, univertsity medical center groningen,university of groningen,the netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038270
- Sponsor's protocol ID
- Nexfin_002
- Status last verified
- Apr 2024
- First submitted
- 23 May 2013
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of the Accuracy of the Nexfin Pressure Signal Compared to Invasive and Noninvasive Arterial Blood Pressure
- ClinicalTrials.gov ID
- NCT02038270
- Acronym / sponsor ID
- Nexfin_002
- Conditions
- Bloodpressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 16 Jan 2014 (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 Nexfin monitoring device relies on noninvasive pressure measurement using a finger-cuff manometer, combined with NIRS technology. The accuracy of the signal is dependent on the degree of vascular unloading, which takes an period before optimal unloading is reached. The evolution of the degree of inaccuracy caused by inclomplete unloading is quantified, and the absolute and relative inaccuracy of the nexfin as a function of the time is determined compared to the invasive blood pressure (IBP).
Secondly, the accuracy of the Nexfin to predict the IBP is compared with the accuracy of noninvasive blood pressure to predict the IBP.
Detailed description
In patients under stable anesthesia conditions, who have IBP and NIBP monitoring, the Nexfin will additionaly be connected. All data will be recorded for at least 30 minutes. NIBP will be measured every 5 minutes The evolution of the NIBP, IBP and Nexfin-derived blood pressure will be analysed to determine the evolution of inaccuracy due to incomplete vascular unloading and to determine the accuracy of Nexfin compared with NIBP to determine IBP.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgical patients | – | –120 Adult patients, that are having a routine surgical procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 120 Adult patients, that are having a routine surgical procedure.
Key inclusion criteria (1 listed)
- Patients that are accepted for surgery
Key exclusion criteria (1 listed)
- Patients unable or unwilling to provide consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
vascular unloading time
Time frame: Start till end of operation
time to optimal vascular unloading
1 secondary outcome
Bloodpressure
Time frame: Start till end of operation
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 18 Apr 2024.
Related trials for Bloodpressure
Recruiting
Effects of Endogenous GIP on Postprandial Blood Pressure in Healthy Individuals
Bloodpressure
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.
Alain Kalmar, dr principal investigator
univertsity medical center groningen,university of groningen,the netherlands
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 Bloodpressure, run by University Medical Center Groningen 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 1 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: finished, as of the sponsor's last update on 18 Apr 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 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?
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?
vascular unloading time (time frame: Start till end of operation). 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 18 Apr 2024.