Surgical Procedure, UnspecifiedNCT01292759
Non-invasive Assessment of Arterial Blood Pressure and Functional Hemodynamic Parameters
An observational study of Surgical Procedure, Unspecified, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
Cardiac output can be monitored using different invasive devices. Nexfin HD is a new, noninvasive device that uses model flow technology to measure stroke volume and thus computes cardiac output (CO). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Surgical Procedure, Unspecified
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2010to not given
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective abdominal surgery
Who may be able to join
- Age > 18 and < 80 years old
- Written informed consent obtained
Who cannot join
- Renal failure
- Heart failure (EF < 25%)
- Peripheral artery occlusion disease
- M. Raynaud
- Rhythms other than sinus
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinik für Anaesthesiology der Universitätsmedizin Mainz
Mainz, 55131
Larissa Philippi, l.philippi@web.de
About this study
Official title: An Evaluation of a New, Non-invasive Monitoring Device in Major Abdominal Surgery Patients
Cardiac output can be monitored using different invasive devices. Nexfin HD is a new, noninvasive device that uses model flow technology to measure stroke volume and thus computes cardiac output (CO). To evaluate this new device the investigators compared esophageal doppler CO to Nexfin HD CO in patients scheduled for elective abdominal surgery.
- Conditions
- Surgical Procedure, Unspecified
- Keywords
- stroke volume, cardiac output, validation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedure, UnspecifiedStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292759
- Sponsor's protocol ID
- 837.194.10 (7203)
- Status last verified
- Jul 2010
- First submitted
- 9 Feb 2011
- Last updated
- 15 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of a New, Non-invasive Monitoring Device in Major Abdominal Surgery Patients
- ClinicalTrials.gov ID
- NCT01292759
- Acronym / sponsor ID
- 837.194.10 (7203)
- Conditions
- Surgical Procedure, Unspecified
- Keywords
- stroke volume, cardiac output, validation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Jul 2010
- First posted
- 10 Feb 2011 (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.
Cardiac output can be monitored using different invasive devices. Nexfin HD is a new, noninvasive device that uses model flow technology to measure stroke volume and thus computes cardiac output (CO). To evaluate this new device the investigators compared esophageal doppler CO to Nexfin HD CO in patients scheduled for elective abdominal surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective abdominal surgery
Key inclusion criteria (2 listed)
- Age > 18 and < 80 years old
- Written informed consent obtained
Key exclusion criteria (5 listed)
- Renal failure
- Heart failure (EF < 25%)
- Peripheral artery occlusion disease
- M. Raynaud
- Rhythms other than sinus
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2011.
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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.
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 Surgical Procedure, Unspecified, run by Johannes Gutenberg University Mainz 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 2 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 15 Feb 2011. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 15 Feb 2011.