Difference in Measured Results Using Four Different Strokevolume Measurements Simultaneously.FourCompNCT01791283
Real-time Comparison of Left Ventricular Strokevolume Measurement by Four Different Methods
An observational study of Difference in Measured Results Using Four Different Strokevolume Measurements Simultaneously., run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
Real-time comparison of three different bedside strokevolumemeasurements (arterial waveform analysis, eosofageal doppler and 2D transthoracal ultrasound) validated against cardiac magnetic resonance imaging (CMRI) Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Difference in Measured Results Using Four Different Strokevolume Measurements Simultaneously.
- What is being tested?
- Arterial waveform analysis, esofageal doppler, transthoracal cardiac ultrasound, Cardiac magnetic resonance imaging.
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2012to Feb 2013
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volounteers
Who may be able to join
None listed.
Who cannot join
- Heart and/or vascular disease such as angina pectoris, arrythmias, claudicatio intermittens e g.
- Diseases in gastrointestinal tract or nose.
- Coagulopathies
- Pregnancy
- Allergys for local anaesthetics
- Claustrofobia
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Departement for intensive care medicine, Universitetssjukhuset
Linköping, 581 85
About this study
Real-time comparison of three different bedside strokevolumemeasurements (arterial waveform analysis, eosofageal doppler and 2D transthoracal ultrasound) validated against cardiac magnetic resonance imaging (CMRI)
Read the detailed description
20 healthy volounteers between age of 20-40 years, no previous medical history undergo simoultaneous left ventrikular strokevolume measurements using three different methods at rest. After datasampling and without moving, the subject then undergo Cardiac Magnetic Resonance Imaging with 2D-throughplane and cine tecnology for validation of volume measurements. The data is then analyzed using Bland-Altman calculation.
- Conditions
- Difference in Measured Results Using Four Different Strokevolume Measurements Simultaneously.
- Being tested
- Arterial waveform analysis, esofageal doppler, transthoracal cardiac ultrasound, Cardiac magnetic resonance imaging.
- Keywords
- Left ventricular stroke volume, Arterial waveform analysis, Esofageal doppler, Ultrasound, Cardiac magnetic Imaging, Limits of agreement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial waveform analysis, esofageal doppler, transthoracal cardiac ultrasound, Cardiac magnetic resonance imaging.Procedure or surgery
Also called Vigileo/FloTrac, Edward Lifesciences (arterial waveform analysis), CardioQ, Deltex medical (esofageal doppler), Philips, Magnetic Resonance Imaging, Vivid S6, GE, Cardiac ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Healthy volounteers with no previous medical history, age between 20-40. Both male and female. Subjects are provided extensive information about the study and the obligations and expectations included. All subjects sign a witnessed informed consent before inclusion. Receives: Procedure: Arterial waveform analysis, esofageal doppler, transthoracal cardiac ultrasound, Cardiac magnetic resonance imaging. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limits of agreement (LOA) is less than 30% using CMRI as validation for each individual measurement of left ventricular stroke volume.
Measured: Study period (1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startAug 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difference in Measured Results Using Four Different Strokevolume Measurements Simultaneously.Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Oscarsson, University Hospital, Linkoeping
- Investigators
- Goran Liffner, MD, Principal investigator, Intensivvardskliniken, Linkoping University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791283
- Sponsor's protocol ID
- FourCompv1
- Acronym
- FourComp
- Status last verified
- Feb 2013
- First submitted
- 12 Feb 2013
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Comparison of Left Ventricular Strokevolume Measurement by Four Different Methods
- ClinicalTrials.gov ID
- NCT01791283
- Acronym / sponsor ID
- FourComp / FourCompv1
- Conditions
- Difference in Measured Results Using Four Different Strokevolume Measurements Simultaneously.
- Keywords
- Left ventricular stroke volume, Arterial waveform analysis, Esofageal doppler, Ultrasound, Cardiac magnetic Imaging, Limits of agreement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 13 Feb 2013 (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.
Real-time comparison of three different bedside strokevolumemeasurements (arterial waveform analysis, eosofageal doppler and 2D transthoracal ultrasound) validated against cardiac magnetic resonance imaging (CMRI)
Detailed description
20 healthy volounteers between age of 20-40 years, no previous medical history undergo simoultaneous left ventrikular strokevolume measurements using three different methods at rest. After datasampling and without moving, the subject then undergo Cardiac Magnetic Resonance Imaging with 2D-throughplane and cine tecnology for validation of volume measurements. The data is then analyzed using Bland-Altman calculation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Procedure: Arterial waveform analysis, esofageal doppler, transthoracal cardiac ultrasound, Cardiac magnetic resonance imaging.Healthy volounteers with no previous medical history, age between 20-40. Both male and female. Subjects are provided extensive information about the study and the obligations and expectations included. All subjects sign a witnessed informed consent before inclusion. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volounteers
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Heart and/or vascular disease such as angina pectoris, arrythmias, claudicatio intermittens e g.
- Diseases in gastrointestinal tract or nose.
- Coagulopathies
- Pregnancy
- Allergys for local anaesthetics
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 |
|---|---|---|
| Arterial waveform analysis, esofageal doppler, transthoracal cardiac ultrasound, Cardiac magnetic resonance imaging.Also: Vigileo/FloTrac, Edward Lifesciences (arterial waveform analysis), CardioQ, Deltex medical (esofageal doppler), Philips, Magnetic Resonance Imaging, Vivid S6, GE, Cardiac ultrasound | Procedure or surgery | Healthy volunteers |
Primary outcome
Limits of agreement (LOA) is less than 30% using CMRI as validation for each individual measurement of left ventricular stroke volume.
Time frame: Study period (1 month)
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 13 Feb 2013.
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.
Goran Liffner, MD principal investigator
Intensivvardskliniken, Linkoping University Hospital
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 Difference in Measured Results Using Four Different Strokevolume Measurements Simultaneously., run by University Hospital, Linkoeping at 1 site in Sweden.
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 0 inclusion and 6 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 13 Feb 2013. 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 Sweden. 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?
Limits of agreement (LOA) is less than 30% using CMRI as validation for each individual measurement of left ventricular stroke volume. (time frame: Study period (1 month)). 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 13 Feb 2013.