Atrial FibrillationNCT02444104
Non-invasive Blood Pressure and Cardiac Output Measurement by Using Applanation Tonometry
An observational study of Atrial Fibrillation and Left Ventricular Failure, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
To evaluate and to validate accuracy, precision and trending ability of blood pressure and cardiac output measurement by applanation tonometry in cardiological patients having: atrial fibrillation severe impaired leftventricular function severe aortic valve stenosis patients having left ventricular assist device… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Left Ventricular Failure, Left Ventricular Impaired Function
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2015to Dec 2016
- 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: Patients enable for study enrollement need to suffer from one of the four cardiological pathologies: 1. atrial fibrillation, 2. severe impaired leftventricular function, 3. severe aortic valve stenosis 4. patients having left ventricular assist device All patients have to be clinically monitored by invasive blood pressure assessment and transcardiopulmonary thermodilution.
Who may be able to join
- atrial fibrillation
- severe impaired leftventricular function
- severe aortic stenosis
- LVAD Patients
Who cannot join
- Age <18 years
- pregnancy
- patients having blood pressure difference of more than 10 mmHg on both arms (measurement by "Riva-Rocci" before study enrolment)
- pre-existing on arterial vessels of the arms
- patients who are not able to give informed consent
Trial locations and contacts
1 site in 1 country.
Sebastian Haas contact
Daniel Reuter contact
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg
Daniel Reuter, dreuter@uke.de
About this study
Official title: Validation of Non-invasive Blood Pressure and Cardiac-output Measurement by Using Applanation Tonometry in Cardiological Patients
To evaluate and to validate accuracy, precision and trending ability of blood pressure and cardiac output measurement by applanation tonometry in cardiological patients having:
- atrial fibrillation
- severe impaired leftventricular function
- severe aortic valve stenosis
- patients having left ventricular assist device
Experimental measurement: continuous blood pressure measurement and cardiac output measurement is performed by the T-Line 200 pro device (Tensys Medical Inc., San Diego, USA) Control measurement: gold-standard continuous blood pressure measurement is performed by invasive blood pressure measurement by arterial cannulation and cardiac output reference is assessed by transcardiopulmonary thermodilution
Read the detailed description
Increasing complexity of medical interventions and critical care treatment in an elderly getting population requires precise and accurate hemodynamic monitoring.(1) However, advanced invasive hemodynamic monitoring is often combined with complications by arterial or central venous catheterization. Complications such as vessel harming, infection, cardiac arrhythmias and nervous lesions are likely to occur.(2-4) Therefore, in the past various techniques of minimal- or non-invasive hemodynamic monitoring devices have been evaluated.(5, 6) One of the very promising technique is continuous non-invasive blood pressure monitoring by applanation tonometry. Published data revealed efficacy of this technique. (7) However, ability of this technique remains unclear in patients suffering from cardiological pathologies leading to changing stroke volumes as in arterial fibrillation, to highly reduces stroke volume as in severe impaired left-ventricular function or in severe aortic valve stenosis. Further, ability of applanation tonometry in patients without having pulsatile blood flow such as in patients with left-ventricular assist device remains unclear. Therefore, validation of this technique should be performed in the presented study.
Further development of applanation tonometry including pulse contour analysis now enables assessment of cardiac output. However, till now there is limited data assessing validation cardiac output measurement by this method. Cardiac output validation should also be performed in the planed clinical study.
- Conditions
- Atrial Fibrillation, Left Ventricular Failure, Left Ventricular Impaired Function, Aortic Valve Stenosis
- Keywords
- Left Ventricular Assist Device
- Medical subject headings
- Atrial Fibrillation, Heart Failure, Aortic Valve Stenosis
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 |
|---|---|---|
| Patients with atrial fibrillation | It is Primarily a comparison of methods , non-invasive measured blood pressure versus invasively measured blood pressure and non-invasively measurement of cardiac output versus invasive cardiac output measurement in patients with atrial fibrillation. | |
| Patients with highly reduced LV function | It is Primarily a comparison of methods , non-invasive measured blood pressure versus invasively measured blood pressure and non-invasively measurement of cardiac output versus invasive cardiac output measurement in patients with a highly reduced left ventricular function (LV function) | |
| Patients with aortic stenosis | It is Primarily a comparison of methods , non-invasive measured blood pressure versus invasively measured blood pressure and non-invasively measurement of cardiac output versus invasive cardiac output measurement in patients with severe aortic stenosis | |
| Patients with LVAD | It is Primarily a comparison of methods , non-invasive measured blood pressure versus invasively measured blood pressure and non-invasively measurement of cardiac output versus invasive cardiac output measurement in patients with left ventricular assist-device (LVAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy and precision of blood pressure and cardiac output by applanation tonometry
Measured: 30 minutes
Secondary outcomes (1)
Trending ability of blood pressure monitoring by applanation tonometry
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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 only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Reuter, Study director, University Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444104
- Sponsor's protocol ID
- TNSYS2015
- Status last verified
- Oct 2015
- First submitted
- 11 May 2015
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Saugel B, Reuter DA. Are we ready for the age of non-invasive haemodynamic monitoring? Br J Anaesth. 2014 Sep;113(3):340-3. doi: 10.1093/bja/aeu145. Epub 2014 May 31. No abstract available.
PubMed 24880826Mandel MA, Dauchot PJ. Radial artery cannulation in 1,000 patients: precautions and complications. J Hand Surg Am. 1977 Nov;2(6):482-5. doi: 10.1016/s0363-5023(77)80030-0.
PubMed 925335Russell JA, Joel M, Hudson RJ, Mangano DT, Schlobohm RM. Prospective evaluation of radial and femoral artery catheterization sites in critically ill adults. Crit Care Med. 1983 Dec;11(12):936-9. doi: 10.1097/00003246-198312000-00007.
PubMed 6641252Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet. 2008 Jul 12;372(9633):139-144. doi: 10.1016/S0140-6736(08)60878-8. Epub 2008 Jun 24.
PubMed 18582931Reuter DA, Huang C, Edrich T, Shernan SK, Eltzschig HK. Cardiac output monitoring using indicator-dilution techniques: basics, limits, and perspectives. Anesth Analg. 2010 Mar 1;110(3):799-811. doi: 10.1213/ANE.0b013e3181cc885a.
PubMed 20185659Saugel B, Trepte CJ, Heckel K, Wagner JY, Reuter DA. Hemodynamic management of septic shock: is it time for "individualized goal-directed hemodynamic therapy" and for specifically targeting the microcirculation? Shock. 2015 Jun;43(6):522-9. doi: 10.1097/SHK.0000000000000345.
PubMed 25643016Saugel B, Meidert AS, Hapfelmeier A, Eyer F, Schmid RM, Huber W. Non-invasive continuous arterial pressure measurement based on radial artery tonometry in the intensive care unit: a method comparison study using the T-Line TL-200pro device. Br J Anaesth. 2013 Aug;111(2):185-90. doi: 10.1093/bja/aet025. Epub 2013 Mar 13.
PubMed 23491946
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Non-invasive Blood Pressure and Cardiac-output Measurement by Using Applanation Tonometry in Cardiological Patients
- ClinicalTrials.gov ID
- NCT02444104
- Acronym / sponsor ID
- TNSYS2015
- Conditions
- Atrial Fibrillation, Left Ventricular Failure, Left Ventricular Impaired Function, Aortic Valve Stenosis
- Keywords
- Left Ventricular Assist Device
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 14 May 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.
To evaluate and to validate accuracy, precision and trending ability of blood pressure and cardiac output measurement by applanation tonometry in cardiological patients having:
- atrial fibrillation
- severe impaired leftventricular function
- severe aortic valve stenosis
- patients having left ventricular assist device
Experimental measurement: continuous blood pressure measurement and cardiac output measurement is performed by the T-Line 200 pro device (Tensys Medical Inc., San Diego, USA) Control measurement: gold-standard continuous blood pressure measurement is performed by invasive blood pressure measurement by arterial cannulation and cardiac output reference is assessed by transcardiopulmonary thermodilution
Detailed description
Increasing complexity of medical interventions and critical care treatment in an elderly getting population requires precise and accurate hemodynamic monitoring.(1) However, advanced invasive hemodynamic monitoring is often combined with complications by arterial or central venous catheterization. Complications such as vessel harming, infection, cardiac arrhythmias and nervous lesions are likely to occur.(2-4) Therefore, in the past various techniques of minimal- or non-invasive hemodynamic monitoring devices have been evaluated.(5, 6) One of the very promising technique is continuous non-invasive blood pressure monitoring by applanation tonometry. Published data revealed efficacy of this technique. (7) However, ability of this technique remains unclear in patients suffering from cardiological pathologies leading to changing stroke volumes as in arterial fibrillation, to highly reduces stroke volume as in severe impaired left-ventricular function or in severe aortic valve stenosis. Further, ability of applanation tonometry in patients without having pulsatile blood flow such as in patients with left-ventricular assist device remains unclear. Therefore, validation of this technique should be performed in the presented study.
Further development of applanation tonometry including pulse contour analysis now enables assessment of cardiac output. However, till now there is limited data assessing validation cardiac output measurement by this method. Cardiac output validation should also be performed in the planed clinical study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with atrial fibrillation | – | –It is Primarily a comparison of methods , non-invasive measured blood pressure versus invasively measured blood pressure and non-invasively measurement of cardiac output versus invasive cardiac output measurement in patients with atrial fibrillation. |
| Patients with highly reduced LV function | – | –It is Primarily a comparison of methods , non-invasive measured blood pressure versus invasively measured blood pressure and non-invasively measurement of cardiac output versus invasive cardiac output measurement in patients with a highly reduced left ventricular function (LV function) |
| Patients with aortic stenosis | – | –It is Primarily a comparison of methods , non-invasive measured blood pressure versus invasively measured blood pressure and non-invasively measurement of cardiac output versus invasive cardiac output measurement in patients with severe aortic stenosis |
| Patients with LVAD | – | –It is Primarily a comparison of methods , non-invasive measured blood pressure versus invasively measured blood pressure and non-invasively measurement of cardiac output versus invasive cardiac output measurement in patients with left ventricular assist-device (LVAD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients enable for study enrollement need to suffer from one of the four cardiological pathologies: 1. atrial fibrillation, 2. severe impaired leftventricular function, 3. severe aortic valve stenosis 4. patients having left ventricular assist device All patients have to be clinically monitored by invasive blood pressure assessment and transcardiopulmonary thermodilution.
Key inclusion criteria (4 listed)
- atrial fibrillation
- severe impaired leftventricular function
- severe aortic stenosis
- LVAD Patients
Key exclusion criteria (5 listed)
- Age <18 years
- pregnancy
- patients having blood pressure difference of more than 10 mmHg on both arms (measurement by "Riva-Rocci" before study enrolment)
- pre-existing on arterial vessels of the arms
- patients who are not able to give informed 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
Accuracy and precision of blood pressure and cardiac output by applanation tonometry
Time frame: 30 minutes
1 secondary outcome
Trending ability of blood pressure monitoring by applanation tonometry
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
- Background: PubMed 24880826Saugel B, Reuter DA. Are we ready for the age of non-invasive haemodynamic monitoring? Br J Anaesth. 2014 Sep;113(3):340-3. doi: 10.1093/bja/aeu145. Epub 2014 May 31. No abstract available.
- Background: PubMed 925335Mandel MA, Dauchot PJ. Radial artery cannulation in 1,000 patients: precautions and complications. J Hand Surg Am. 1977 Nov;2(6):482-5. doi: 10.1016/s0363-5023(77)80030-0.
- Background: PubMed 6641252Russell JA, Joel M, Hudson RJ, Mangano DT, Schlobohm RM. Prospective evaluation of radial and femoral artery catheterization sites in critically ill adults. Crit Care Med. 1983 Dec;11(12):936-9. doi: 10.1097/00003246-198312000-00007.
- Background: PubMed 18582931Weiser TG, Regenbogen SE, Thompson KD, Haynes AB, Lipsitz SR, Berry WR, Gawande AA. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet. 2008 Jul 12;372(9633):139-144. doi: 10.1016/S0140-6736(08)60878-8. Epub 2008 Jun 24.
- Background: PubMed 20185659Reuter DA, Huang C, Edrich T, Shernan SK, Eltzschig HK. Cardiac output monitoring using indicator-dilution techniques: basics, limits, and perspectives. Anesth Analg. 2010 Mar 1;110(3):799-811. doi: 10.1213/ANE.0b013e3181cc885a.
- Background: PubMed 25643016Saugel B, Trepte CJ, Heckel K, Wagner JY, Reuter DA. Hemodynamic management of septic shock: is it time for "individualized goal-directed hemodynamic therapy" and for specifically targeting the microcirculation? Shock. 2015 Jun;43(6):522-9. doi: 10.1097/SHK.0000000000000345.
- Background: PubMed 23491946Saugel B, Meidert AS, Hapfelmeier A, Eyer F, Schmid RM, Huber W. Non-invasive continuous arterial pressure measurement based on radial artery tonometry in the intensive care unit: a method comparison study using the T-Line TL-200pro device. Br J Anaesth. 2013 Aug;111(2):185-90. doi: 10.1093/bja/aet025. Epub 2013 Mar 13.
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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.
Sebastian Haas contact
Daniel Reuter contact
Daniel Reuter study director
University Hamburg
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 Atrial Fibrillation and Left Ventricular Failure, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Oct 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sebastian Haas (s.haas@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy and precision of blood pressure and cardiac output by applanation tonometry (time frame: 30 minutes). 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 NCT02444104, which also lists 7 linked publications.
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 Oct 2015.