Venous Pressure, CentralNCT01079611
Non-invasive Assessments of Central Venous Pressure
An observational study of Venous Pressure, Central and Ultrasonic Diagnosis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Background: Estimates of central venous pressure (CVP) can be very helpful in guiding fluid therapy in the intensive care unit, operating room or emergency room. Current standard technique for CVP assessment is invasive, requiring insertion of a catheter into a subclavian, internal jugular or peripheral vein. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Pressure, Central, Ultrasonic Diagnosis
- How many people
- 81 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2010to Nov 2011
- 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: This single center, prospective observational study will be performed at the surgical intensive care unit (ICU) of the tertiary care teaching hospital of the University of Basel. ICU, rather than Emergency Department patients will be consecutively enrolled because of the higher prevalence of CVP catheters and the higher likelihood of clinical stability (by means of hemodynamic parameters, therapeutic interventions etc.).
Who may be able to join
- Patients age greater than 18 years are study candidates if they need central venous access and invasive hemodynamic monitoring, according to the discretion of the treating physician.
- Informed consent is given.
Who cannot join
- Patients are ineligible if they have a history of neck or body radiotherapy and/or previous or active upper-extremity deep venous thrombosis.
- Informed consent is not given.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Assessments of Central Venous Pressure by Ultrasound and Clinical Examination: a Prospective Comparative Study
Background: Estimates of central venous pressure (CVP) can be very helpful in guiding fluid therapy in the intensive care unit, operating room or emergency room. Current standard technique for CVP assessment is invasive, requiring insertion of a catheter into a subclavian, internal jugular or peripheral vein. Several ultrasound based and clinical methods have been described as potential non-invasive alternatives to assess CVP.
Aim: To prospectively evaluate the accuracy of CVP assessment by a) inferior vena cava diameter and collapsibility b) internal jugular vein diameter c) compression sonography of a forearm vein and d) clinical assessment of peripheral vein collapse in comparison to invasive CVP measurement.
Read more
Study design: single center, prospective observational study
Patients and Methods:
We will examine 77 consecutive patients with invasive venous access and invasive hemodynamic monitoring at the surgical intensive care unit (ICU). After obtaining informed consent, ultrasound examinations of the inferior vena cava, internal jugular vein and compression sonography of a forearm vein as well as clinical evaluation of peripheral vein collapsibility will be performed in a random sequence by different experienced examiner. Invasive CVP is recorded simultaneously to each measurement. Examiners are blinded to clinical parameters and results of previous CVP measurements.
Primary endpoint: Accuracy of each non-invasive method to determine CVP defined by invasively measured CVP.
Secondary endpoint: Comparison of the feasibility of each non-invasive method.
Expected results: We hypothesize that sonographic measurement of inferior vena cava diameter, internal jugular vein diameter and compression sonography of a forearm vein as well as clinical assessment of peripheral vein collapsibility are reliable methods for CVP determination in comparison to invasive CVP measurement.
Significance: The validation and comparison of sonographic / clinic CVP assessment would enable clinicians to choose an accurate non-invasive method to assess volume status which is an important adjunct in the management of many critically ill patients. The non-invasiveness of these methods broadens the feasibility to measure CVP and may guide fluid therapy in new patient populations.
- Conditions
- Venous Pressure, Central, Ultrasonic Diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2010
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous Pressure, CentralStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heiko Uthoff, University Hospital, Basel, Switzerland
- Investigators
- Heiko Uthoff, M.D., Principal investigator, University Hospital Basel, AngiologyKurt A Jaeger, M.D., Principal investigator, University Hospital Basel, Angiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079611
- Sponsor's protocol ID
- CVP1
- Status last verified
- Jun 2012
- First submitted
- 2 Mar 2010
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Uthoff H, Siegemund M, Aschwanden M, Hunziker L, Fabbro T, Baumann U, Jaeger KA, Imfeld S, Staub D. Prospective comparison of noninvasive, bedside ultrasound methods for assessing central venous pressure. Ultraschall Med. 2012 Dec;33(7):E256-E262. doi: 10.1055/s-0031-1299506. Epub 2012 Jun 1.
PubMed 22660962
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Assessments of Central Venous Pressure by Ultrasound and Clinical Examination: a Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT01079611
- Acronym / sponsor ID
- CVP1
- Conditions
- Venous Pressure, Central, Ultrasonic Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 3 Mar 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.
Background: Estimates of central venous pressure (CVP) can be very helpful in guiding fluid therapy in the intensive care unit, operating room or emergency room. Current standard technique for CVP assessment is invasive, requiring insertion of a catheter into a subclavian, internal jugular or peripheral vein. Several ultrasound based and clinical methods have been described as potential non-invasive alternatives to assess CVP.
Aim: To prospectively evaluate the accuracy of CVP assessment by a) inferior vena cava diameter and collapsibility b) internal jugular vein diameter c) compression sonography of a forearm vein and d) clinical assessment of peripheral vein collapse in comparison to invasive CVP measurement.
Study design: single center, prospective observational study
Patients and Methods:
We will examine 77 consecutive patients with invasive venous access and invasive hemodynamic monitoring at the surgical intensive care unit (ICU). After obtaining informed consent, ultrasound examinations of the inferior vena cava, internal jugular vein and compression sonography of a forearm vein as well as clinical evaluation of peripheral vein collapsibility will be performed in a random sequence by different experienced examiner. Invasive CVP is recorded simultaneously to each measurement. Examiners are blinded to clinical parameters and results of previous CVP measurements.
Primary endpoint: Accuracy of each non-invasive method to determine CVP defined by invasively measured CVP.
Secondary endpoint: Comparison of the feasibility of each non-invasive method.
Expected results: We hypothesize that sonographic measurement of inferior vena cava diameter, internal jugular vein diameter and compression sonography of a forearm vein as well as clinical assessment of peripheral vein collapsibility are reliable methods for CVP determination in comparison to invasive CVP measurement.
Significance: The validation and comparison of sonographic / clinic CVP assessment would enable clinicians to choose an accurate non-invasive method to assess volume status which is an important adjunct in the management of many critically ill patients. The non-invasiveness of these methods broadens the feasibility to measure CVP and may guide fluid therapy in new patient populations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This single center, prospective observational study will be performed at the surgical intensive care unit (ICU) of the tertiary care teaching hospital of the University of Basel. ICU, rather than Emergency Department patients will be consecutively enrolled because of the higher prevalence of CVP catheters and the higher likelihood of clinical stability (by means of hemodynamic parameters, therapeutic interventions etc.).
Key inclusion criteria (2 listed)
- Patients age greater than 18 years are study candidates if they need central venous access and invasive hemodynamic monitoring, according to the discretion of the treating physician.
- Informed consent is given.
Key exclusion criteria (2 listed)
- Patients are ineligible if they have a history of neck or body radiotherapy and/or previous or active upper-extremity deep venous thrombosis.
- Informed consent is not given.
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
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 20 Jun 2012.
- Results publication: PubMed 22660962Uthoff H, Siegemund M, Aschwanden M, Hunziker L, Fabbro T, Baumann U, Jaeger KA, Imfeld S, Staub D. Prospective comparison of noninvasive, bedside ultrasound methods for assessing central venous pressure. Ultraschall Med. 2012 Dec;33(7):E256-E262. doi: 10.1055/s-0031-1299506. Epub 2012 Jun 1.
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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.
Heiko Uthoff, M.D. principal investigator
University Hospital Basel, Angiology
Kurt A Jaeger, M.D. principal investigator
University Hospital Basel, Angiology
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 Venous Pressure, Central and Ultrasonic Diagnosis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 2 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 20 Jun 2012. 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 Switzerland. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01079611, which also lists 1 linked publication.
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 20 Jun 2012.