Aortic Valve SurgeryPRAGUENCT03815188
Use of the SonoSite Probe for Measuring Jugular Venous Pressure
An observational study of Aortic Valve Surgery, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This prospective study will be performed in the Cardiothoracic (Chesterman) Department at Sheffield Teaching Hospitals NHSFT, Northern General Hospital. Pre-operative patients undergoing surgical valvular intervention, breathing both spontaneously and mechanically will be included in the trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Surgery
- How many people
- 124 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Feb 2019to 31 Aug 2019
- 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: Pre-operative patients undergoing heart valve surgery will be selected and data recorded from each patient on the day of their surgery. This patient cohort is required in order to be able to accurately measure their JVP upon physical examination. Patients must have a central line inserted as part of their ongoing clinical management. Patients will be selected based on the weekly surgery schedule and will require participation of the anaesthetist. The anaesthetist will be required to insert the central line, anaesthetise the patient and adjust the transducer when asked.
Who may be able to join
- Patients undergoing cardiac surgery
- Patients who have a central line inserted during surgery
- Patients able and willing to give consent in verbal and written English.
Who cannot join
- Patients under the age of 18
- Patients unable to provide consent in verbal and written English
- Patients with thyroid enlargement or alternative reason causing obstruction to venous anatomy
- Patients with significant tricuspid regurgitation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS FT
Sheffield, England, S10 2JF
About this study
This prospective study will be performed in the Cardiothoracic (Chesterman) Department at Sheffield Teaching Hospitals NHSFT, Northern General Hospital. Pre-operative patients undergoing surgical valvular intervention, breathing both spontaneously and mechanically will be included in the trial. All patients will already have a central venous catheter inserted as part of their ongoing care. Patients will be eligible for the study irrespective of diagnosis or neck size. Patient demographical data will be recorded by Sam Jenkins following written consent, the day before the trial.
The goal of this study is to determine if ultrasound assessment of Jugular Venous Pressure (JVP) accurately predicts Central Venous Pressure (CVP). Secondary objectives aim to identify if using the angle of Louis to approximate the location of the right atrium produces inaccuracies when measuring JVP. Comparing results in patients breathing spontaneously or under positive pressure ventilation will identify if the form of ventilation impacts on JVP and CVP recording. Correlating results between physical JVP examination and ultrasound assessment of JVP to measure CVP will conclude if ultrasound is a more appropriate tool, in an era where the physical examination of the cardiovascular system is becoming less valuable.
Read the detailed description
Initial exploratory investigations will compare left-sided and right-sided Jugular Venous Pressure (JVP) using ultrasonography. Should results show that they are the same, the central line is to be placed into the right internal jugular vein when required.
To begin the trial and whilst the patient is spontaneously breathing, a physical examination of the right JVP will be performed. A central line will be inserted with the patient awake into the right internal jugular vein. Left-sided ultrasound of JVP and Central Venous Pressure (CVP) will be measured using the right-sided catheter will be recorded simultaneously. The tip of the catheter attached to the transducer (which is zeroed to the reference point) will be placed at the point of venous collapse, identified by ultrasonography, to identify if the JVP and CVP match. The tip of the catheter will then be placed at the angle of Louis. Measurement of the pressure difference between the angle of Louis and the reference point will identify if this value shows variability compared to previous approximations of 5cm above the right atrium. With the patient anaesthetised and mechanically breathing, left JVP and CVP will be measured once more. Twenty-four hours post-surgery, ultrasound of the JVP and CVP will be measured with the patient breathing spontaneously.
The physical JVP examination will be recorded from the opposite side to the central venous catheter. The bed will be adjusted to an angle between 30 and 60 degrees, that most clearly identifies the collapsing vein. Differentiation between the JVP and the carotid pulse must be distinguished. Tangential lighting using a flashlight should be used to correctly identify and note the apex of the jugular venous pulsations. Recordings will be taken at end-expiration allowing the vertical distance between the venous meniscus and phlebostatic axis to be measured. JVP will be measured in millimetres of water.
Ultrasound recordings will be made using the SonoSite ultrasound probe by Sam Jenkins. The equipment and gels required are used routinely on site and will be supplied by Sheffield Teaching Hospitals. The SonoSite probe will be calibrated prior to each use, based on the recommendations of the manufacturer. The angle of the bed is kept constant and the patient will remain in the same position following the physical JVP examination. Ultrasound gel will be applied, again on the opposite side to the central venous catheter. Locating the area of venous collapse will be identified following visualisation from both longitudinal and transverse planes. The apex of venous collapse at end-expiration will be marked using the longitudinal view. Corroboration of the correct position of the probe by looking at the transverse view will be performed prior to marking of venous collapse.
CVP will be measured once the central venous catheter has been zeroed. The reference point of the transducer will be placed at the 4th intercostal space, mid-axillary line. The bed should still be kept at a constant angle for this measurement. The mean of the 'a' wave upon end-expiration will be taken. Converting the CVP from millimetres of mercury to millimetres of water will allow direct comparison to prior findings of JVP.
- Conditions
- Aortic Valve Surgery
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 |
|---|---|---|
| Heart Valve Surgery | Pre-operative patients undergoing heart valve surgery will be selected and data recorded from each patient on the day of their surgery. This patient cohort is required in order to be able to accurately measure their JVP upon physical examination. Patients must have a central line inserted as part of their ongoing clinical management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonography
Ultrasonography is expected to be a more accurate measure of CVP compared to physical JVP examination and is hypothesised to accurately predict CVP.
Measured: Through study completion - 30/09/2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start15 Feb 2019
- Primary completion30 Jun 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve SurgeryStudies 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
- Retrospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815188
- Sponsor's protocol ID
- STH20529
- Acronym
- PRAGUE
- Status last verified
- Aug 2019
- First submitted
- 21 Jan 2019
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brennan JM, Blair JE, Goonewardena S, Ronan A, Shah D, Vasaiwala S, Brooks E, Levy A, Kirkpatrick JN, Spencer KT. A comparison by medicine residents of physical examination versus hand-carried ultrasound for estimation of right atrial pressure. Am J Cardiol. 2007 Jun 1;99(11):1614-6. doi: 10.1016/j.amjcard.2007.01.037. Epub 2007 Apr 18.
PubMed 17531592Cook DJ, Simel DL. The Rational Clinical Examination. Does this patient have abnormal central venous pressure? JAMA. 1996 Feb 28;275(8):630-4. No abstract available.
PubMed 8594245Deol GR, Collett N, Ashby A, Schmidt GA. Ultrasound accurately reflects the jugular venous examination but underestimates central venous pressure. Chest. 2011 Jan;139(1):95-100. doi: 10.1378/chest.10-1301. Epub 2010 Aug 26.
PubMed 20798190Fletcher RH, Fletcher SW. Has medicine outgrown physical diagnosis? Ann Intern Med. 1992 Nov 1;117(9):786-7. doi: 10.7326/0003-4819-117-9-786. No abstract available.
PubMed 1416582Jang T, Aubin C, Naunheim R, Char D. Ultrasonography of the internal jugular vein in patients with dyspnea without jugular venous distention on physical examination. Ann Emerg Med. 2004 Aug;44(2):160-8. doi: 10.1016/j.annemergmed.2004.03.014.
PubMed 15278091Lipton B. Estimation of central venous pressure by ultrasound of the internal jugular vein. Am J Emerg Med. 2000 Jul;18(4):432-4. doi: 10.1053/ajem.2000.7335.
PubMed 10919533Mangione S, Nieman LZ. Cardiac auscultatory skills of internal medicine and family practice trainees. A comparison of diagnostic proficiency. JAMA. 1997 Sep 3;278(9):717-22.
PubMed 9286830Seth R, Magner P, Matzinger F, van Walraven C. How far is the sternal angle from the mid-right atrium? J Gen Intern Med. 2002 Nov;17(11):852-6. doi: 10.1046/j.1525-1497.2002.20101.x.
PubMed 12406357Socransky SJ, Wiss R, Robins R, Anawati A, Roy MA, Yeung IC. Defining normal jugular venous pressure with ultrasonography. CJEM. 2010 Jul;12(4):320-4. doi: 10.1017/s1481803500012409.
PubMed 20650024Sondergaard S, Parkin G, Aneman A. Central venous pressure: we need to bring clinical use into physiological context. Acta Anaesthesiol Scand. 2015 May;59(5):552-60. doi: 10.1111/aas.12490. Epub 2015 Feb 13.
PubMed 25684176Jenkins S, Knowles P, Briffa N. Portable ultrasound assessment of jugular venous pressure is an accurate method for estimating volaemic status in patients with cardiac disease. J Ultrasound. 2022 Dec;25(4):939-947. doi: 10.1007/s40477-022-00654-7. Epub 2022 Mar 15.
PubMed 35292924
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the SonoSite Probe for Measuring Jugular Venous Pressure
- ClinicalTrials.gov ID
- NCT03815188
- Acronym / sponsor ID
- PRAGUE / STH20529
- Conditions
- Aortic Valve Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 24 Jan 2019 (actual)
- 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.
This prospective study will be performed in the Cardiothoracic (Chesterman) Department at Sheffield Teaching Hospitals NHSFT, Northern General Hospital. Pre-operative patients undergoing surgical valvular intervention, breathing both spontaneously and mechanically will be included in the trial. All patients will already have a central venous catheter inserted as part of their ongoing care. Patients will be eligible for the study irrespective of diagnosis or neck size. Patient demographical data will be recorded by Sam Jenkins following written consent, the day before the trial.
The goal of this study is to determine if ultrasound assessment of Jugular Venous Pressure (JVP) accurately predicts Central Venous Pressure (CVP). Secondary objectives aim to identify if using the angle of Louis to approximate the location of the right atrium produces inaccuracies when measuring JVP. Comparing results in patients breathing spontaneously or under positive pressure ventilation will identify if the form of ventilation impacts on JVP and CVP recording. Correlating results between physical JVP examination and ultrasound assessment of JVP to measure CVP will conclude if ultrasound is a more appropriate tool, in an era where the physical examination of the cardiovascular system is becoming less valuable.
Detailed description
Initial exploratory investigations will compare left-sided and right-sided Jugular Venous Pressure (JVP) using ultrasonography. Should results show that they are the same, the central line is to be placed into the right internal jugular vein when required.
To begin the trial and whilst the patient is spontaneously breathing, a physical examination of the right JVP will be performed. A central line will be inserted with the patient awake into the right internal jugular vein. Left-sided ultrasound of JVP and Central Venous Pressure (CVP) will be measured using the right-sided catheter will be recorded simultaneously. The tip of the catheter attached to the transducer (which is zeroed to the reference point) will be placed at the point of venous collapse, identified by ultrasonography, to identify if the JVP and CVP match. The tip of the catheter will then be placed at the angle of Louis. Measurement of the pressure difference between the angle of Louis and the reference point will identify if this value shows variability compared to previous approximations of 5cm above the right atrium. With the patient anaesthetised and mechanically breathing, left JVP and CVP will be measured once more. Twenty-four hours post-surgery, ultrasound of the JVP and CVP will be measured with the patient breathing spontaneously.
The physical JVP examination will be recorded from the opposite side to the central venous catheter. The bed will be adjusted to an angle between 30 and 60 degrees, that most clearly identifies the collapsing vein. Differentiation between the JVP and the carotid pulse must be distinguished. Tangential lighting using a flashlight should be used to correctly identify and note the apex of the jugular venous pulsations. Recordings will be taken at end-expiration allowing the vertical distance between the venous meniscus and phlebostatic axis to be measured. JVP will be measured in millimetres of water.
Ultrasound recordings will be made using the SonoSite ultrasound probe by Sam Jenkins. The equipment and gels required are used routinely on site and will be supplied by Sheffield Teaching Hospitals. The SonoSite probe will be calibrated prior to each use, based on the recommendations of the manufacturer. The angle of the bed is kept constant and the patient will remain in the same position following the physical JVP examination. Ultrasound gel will be applied, again on the opposite side to the central venous catheter. Locating the area of venous collapse will be identified following visualisation from both longitudinal and transverse planes. The apex of venous collapse at end-expiration will be marked using the longitudinal view. Corroboration of the correct position of the probe by looking at the transverse view will be performed prior to marking of venous collapse.
CVP will be measured once the central venous catheter has been zeroed. The reference point of the transducer will be placed at the 4th intercostal space, mid-axillary line. The bed should still be kept at a constant angle for this measurement. The mean of the 'a' wave upon end-expiration will be taken. Converting the CVP from millimetres of mercury to millimetres of water will allow direct comparison to prior findings of JVP.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Valve Surgery | – | –Pre-operative patients undergoing heart valve surgery will be selected and data recorded from each patient on the day of their surgery. This patient cohort is required in order to be able to accurately measure their JVP upon physical examination. Patients must have a central line inserted as part of their ongoing clinical management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pre-operative patients undergoing heart valve surgery will be selected and data recorded from each patient on the day of their surgery. This patient cohort is required in order to be able to accurately measure their JVP upon physical examination. Patients must have a central line inserted as part of their ongoing clinical management. Patients will be selected based on the weekly surgery schedule and will require participation of the anaesthetist. The anaesthetist will be required to insert the central line, anaesthetise the patient and adjust the transducer when asked.
Key inclusion criteria (3 listed)
- Patients undergoing cardiac surgery
- Patients who have a central line inserted during surgery
- Patients able and willing to give consent in verbal and written English.
Key exclusion criteria (4 listed)
- Patients under the age of 18
- Patients unable to provide consent in verbal and written English
- Patients with thyroid enlargement or alternative reason causing obstruction to venous anatomy
- Patients with significant tricuspid regurgitation
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
Ultrasonography
Time frame: Through study completion - 30/09/2019
Ultrasonography is expected to be a more accurate measure of CVP compared to physical JVP examination and is hypothesised to accurately predict CVP.
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 31 Oct 2019.
- Background: PubMed 17531592Brennan JM, Blair JE, Goonewardena S, Ronan A, Shah D, Vasaiwala S, Brooks E, Levy A, Kirkpatrick JN, Spencer KT. A comparison by medicine residents of physical examination versus hand-carried ultrasound for estimation of right atrial pressure. Am J Cardiol. 2007 Jun 1;99(11):1614-6. doi: 10.1016/j.amjcard.2007.01.037. Epub 2007 Apr 18.
- Background: PubMed 8594245Cook DJ, Simel DL. The Rational Clinical Examination. Does this patient have abnormal central venous pressure? JAMA. 1996 Feb 28;275(8):630-4. No abstract available.
- Background: PubMed 20798190Deol GR, Collett N, Ashby A, Schmidt GA. Ultrasound accurately reflects the jugular venous examination but underestimates central venous pressure. Chest. 2011 Jan;139(1):95-100. doi: 10.1378/chest.10-1301. Epub 2010 Aug 26.
- Background: PubMed 1416582Fletcher RH, Fletcher SW. Has medicine outgrown physical diagnosis? Ann Intern Med. 1992 Nov 1;117(9):786-7. doi: 10.7326/0003-4819-117-9-786. No abstract available.
- Background: PubMed 15278091Jang T, Aubin C, Naunheim R, Char D. Ultrasonography of the internal jugular vein in patients with dyspnea without jugular venous distention on physical examination. Ann Emerg Med. 2004 Aug;44(2):160-8. doi: 10.1016/j.annemergmed.2004.03.014.
- Background: PubMed 10919533Lipton B. Estimation of central venous pressure by ultrasound of the internal jugular vein. Am J Emerg Med. 2000 Jul;18(4):432-4. doi: 10.1053/ajem.2000.7335.
- Background: PubMed 9286830Mangione S, Nieman LZ. Cardiac auscultatory skills of internal medicine and family practice trainees. A comparison of diagnostic proficiency. JAMA. 1997 Sep 3;278(9):717-22.
- Background: PubMed 12406357Seth R, Magner P, Matzinger F, van Walraven C. How far is the sternal angle from the mid-right atrium? J Gen Intern Med. 2002 Nov;17(11):852-6. doi: 10.1046/j.1525-1497.2002.20101.x.
- Background: PubMed 20650024Socransky SJ, Wiss R, Robins R, Anawati A, Roy MA, Yeung IC. Defining normal jugular venous pressure with ultrasonography. CJEM. 2010 Jul;12(4):320-4. doi: 10.1017/s1481803500012409.
- Background: PubMed 25684176Sondergaard S, Parkin G, Aneman A. Central venous pressure: we need to bring clinical use into physiological context. Acta Anaesthesiol Scand. 2015 May;59(5):552-60. doi: 10.1111/aas.12490. Epub 2015 Feb 13.
- Derived from this study: PubMed 35292924Jenkins S, Knowles P, Briffa N. Portable ultrasound assessment of jugular venous pressure is an accurate method for estimating volaemic status in patients with cardiac disease. J Ultrasound. 2022 Dec;25(4):939-947. doi: 10.1007/s40477-022-00654-7. Epub 2022 Mar 15.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Aortic Valve Surgery, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 3 inclusion and 4 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 31 Oct 2019. 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 United Kingdom. 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?
Ultrasonography (time frame: Through study completion - 30/09/2019). 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 NCT03815188, which also lists 11 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 31 Oct 2019.