Stroke VolumeVaSNexNCT01263990
Validation of Stroke Volume Measurement by a New Noninvasive Hemodynamic Monitoring System (NexFin)in Comparison to Different Invasive Procedures as Picco2, FloTrac and TEE
A study testing NexFin in people with Stroke Volume and Mean Arterial Pressure, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Main hypothesis: there is no difference between stroke volume measurements recorded by a new noninvasive finger cuff system (NexFin) and invasive hemodynamic monitoring systems as Picco2-system, FloTrac and transesophageal echocardiography Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Volume, Mean Arterial Pressure
- What is being tested?
- NexFin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2010to Jun 2013
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing orthopedic surgery with need for invasive blood pressure measurements
- age ≥ 18 years
- signed informed consent
- no participation on another interventional study
Who cannot join
- refusal of participation
- patients who are not able to sign informed consent
- atrial fibrillation with arrhythmia
- peripheral arterial disease > Fontain IIa
- scleroderma
- presence of an arterio-venous shunt on upper limb
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- contraindication for femoral arterial vascular access
- contraindication for transesophageal echocardiography
- stage III heart valve defects
- shunt heart defects
- solitary regional anaesthesia
- pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum
Berlin, 10117
About this study
Official title: Prospective, Monocentric Pilot Study for the Validation of Stroke Volume by Use of NexFin in Comparison to Different Hemodynamic Monitoring Procedures (Picco2, FloTrac and TEE)
Main hypothesis: there is no difference between stroke volume measurements recorded by a new noninvasive finger cuff system (NexFin) and invasive hemodynamic monitoring systems as Picco2-system, FloTrac and transesophageal echocardiography
Read the detailed description
In high risc patients undergoing orthopedic surgery an extended cardiopulmonary observation improves patients safety and postoperative outcome. Therefore invasive procedures as Picco2-system, FloTrac and transesophageal echocardiography (tee) have the advantage to measure or calculate stroke volume. Disadvantage of this treatments is the need for a vascular access with all its complications.
In this study the stroke volume measured by a new noninvasive finger cuff system (NexFin) should be validated in comparison to invasive hemodynamic monitoring systems as Picco2-system, FloTrac and tee.
- Conditions
- Stroke Volume, Mean Arterial Pressure
- Being tested
- NexFin
- Keywords
- hemodynamic monitoring systems, stroke volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NexFinDevice
noninvasive finger cuff system
| Study group | Role | What they receive |
|---|---|---|
| Nexfin | No intervention | Nexfin is used in all patients Receives: Device: NexFin |
What is being measured
The primary outcome is the main question the study is designed to answer.
stroke volume
Measured: preinduction, 3 and 15 minutes after induction, before and after a volume challenge, 30 minutes after induction, end of surgery
Secondary outcomes (1)
mean arterial pressure
Measured: preinduction, 3 and 15 minutes after induction, before and after volume challenge, 30 minutes after induction, end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startSep 2010
- Primary completionMay 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke VolumeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Sander, Charite University, Berlin, Germany
- Investigators
- Michael Sander, MD, Principal investigator, Dept. of Anesthesiology Charité Universitaetsmedizin BerlinClaudia Spies, MD, Study chair, Dept. of Anesthesiology Charité Universitaetsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263990
- Sponsor's protocol ID
- VaSNex
- Other IDs
- EA1/199/10
- Acronym
- VaSNex
- Status last verified
- Aug 2013
- First submitted
- 14 Dec 2010
- Last updated
- 12 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Monocentric Pilot Study for the Validation of Stroke Volume by Use of NexFin in Comparison to Different Hemodynamic Monitoring Procedures (Picco2, FloTrac and TEE)
- ClinicalTrials.gov ID
- NCT01263990
- Acronym / sponsor ID
- VaSNex / VaSNex
- Conditions
- Stroke Volume, Mean Arterial Pressure
- Keywords
- hemodynamic monitoring systems, stroke volume
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 21 Dec 2010 (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.
Main hypothesis: there is no difference between stroke volume measurements recorded by a new noninvasive finger cuff system (NexFin) and invasive hemodynamic monitoring systems as Picco2-system, FloTrac and transesophageal echocardiography
Detailed description
In high risc patients undergoing orthopedic surgery an extended cardiopulmonary observation improves patients safety and postoperative outcome. Therefore invasive procedures as Picco2-system, FloTrac and transesophageal echocardiography (tee) have the advantage to measure or calculate stroke volume. Disadvantage of this treatments is the need for a vascular access with all its complications.
In this study the stroke volume measured by a new noninvasive finger cuff system (NexFin) should be validated in comparison to invasive hemodynamic monitoring systems as Picco2-system, FloTrac and tee.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nexfin | No intervention | Device: NexFinNexfin is used in all patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients undergoing orthopedic surgery with need for invasive blood pressure measurements
- age ≥ 18 years
- signed informed consent
- no participation on another interventional study
Key exclusion criteria (12 listed)
- refusal of participation
- patients who are not able to sign informed consent
- atrial fibrillation with arrhythmia
- peripheral arterial disease > Fontain IIa
- scleroderma
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 |
|---|---|---|
| NexFinnoninvasive finger cuff system | Device | Nexfin |
Primary outcome
stroke volume
Time frame: preinduction, 3 and 15 minutes after induction, before and after a volume challenge, 30 minutes after induction, end of surgery
1 secondary outcome
mean arterial pressure
Time frame: preinduction, 3 and 15 minutes after induction, before and after volume challenge, 30 minutes after induction, end of surgery
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 Aug 2013.
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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.
Michael Sander, MD principal investigator
Dept. of Anesthesiology Charité Universitaetsmedizin Berlin
Claudia Spies, MD study chair
Dept. of Anesthesiology Charité Universitaetsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NexFin in people with Stroke Volume and Mean Arterial Pressure, run by Charite University, Berlin, Germany 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 12 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 Aug 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 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?
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?
stroke volume (time frame: preinduction, 3 and 15 minutes after induction, before and after a volume challenge, 30 minutes after induction, end of surgery). 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 Aug 2013.