NCT03815188

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 24, 2019

Completed
22 days until next milestone

Study Start

First participant enrolled

February 15, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

October 31, 2019

Status Verified

August 1, 2019

Enrollment Period

5 months

First QC Date

January 21, 2019

Last Update Submit

October 30, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Ultrasonography

    Ultrasonography is expected to be a more accurate measure of CVP compared to physical JVP examination and is hypothesised to accurately predict CVP.

    Through study completion - 30/09/2019

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Teaching Hospitals NHS FT

Sheffield, England, S10 2JF, United Kingdom

Location

Related Publications (11)

  • 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.

    PMID: 17531592BACKGROUND
  • Cook 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.

    PMID: 8594245BACKGROUND
  • Deol 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.

    PMID: 20798190BACKGROUND
  • Fletcher 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.

    PMID: 1416582BACKGROUND
  • Jang 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.

    PMID: 15278091BACKGROUND
  • Lipton 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.

    PMID: 10919533BACKGROUND
  • Mangione 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.

    PMID: 9286830BACKGROUND
  • Seth 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.

    PMID: 12406357BACKGROUND
  • Socransky 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.

    PMID: 20650024BACKGROUND
  • Sondergaard 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.

    PMID: 25684176BACKGROUND
  • Jenkins 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.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2019

First Posted

January 24, 2019

Study Start

February 15, 2019

Primary Completion

June 30, 2019

Study Completion

August 31, 2019

Last Updated

October 31, 2019

Record last verified: 2019-08

Locations