Ventricular Function, RightTEENCT03264183

Validating TEE Measurements of Right Ventricular Function

An observational study of Ventricular Function, Right and Echocardiography, Transesophageal, run by Milton S. Hershey Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Ventricular Function, Right, Echocardiography, Transesophageal
What is being tested?: Transesophageal Echocardiography and Transthoracic Echocardiography
How many people: 126 participants
Where: 1 siteUnited States
Study dates: 18 Sep 2017to 10 Oct 2018
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: All patients undergoing elective cardiac surgery, which as a standard of care, requires transesophageal echocardiography.

Who may be able to join

Adult patients undergoing elective cardiac surgery requiring TEE

Who cannot join

Patient who do not wish to consent
Patients with contraindications to TEE
Urgent or emergent cardiac surgery
Patients with preexisting open chest
Patients with intrathoracic hardware (VAD, thoracostomy tube, etc)
Non-English speaking subjects
Cognitively impaired adults
Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033

Other trials in United States

About this study

Official title: Validating Transesophageal Echocardiographic Measurements of Right Ventricular Function

Transesophageal echocardiography (TEE) is becoming a more prevalent method of monitoring and diagnosis in the perioperative setting for critically ill patients and patients undergoing cardiac surgery. Many TEE measurements are extrapolated from transthoracic echocardiography (TTE) data and have not validated by transesophageal means. The aim of this study is to validate TEE assessment of right ventricular function by comparing them to simultaneously measured TTE measurements.

Likewise, there are currently no agreed upon values for RV free wall strain. Therefore, the investigators will attempt to define a range of normal values of RV free wall strain as compared to the other measures of RV function.

Read the detailed description

Traditionally, all echocardiographic measurements have been studied utilizing TTE. Therefore the normal values and ranges for pathology findings have been defined by transthoracic means alone. TEE offers different images planes when compared to TTE, which may make the measurements obtained differ from those obtained by TTE. In the operating room environment the vast majority of echocardiography is completed by transesophageal means for many reasons; largely access to the patient and the continuous use of TEE as a hemodynamic monitor. However, given the fact that most echocardiographic measurements have only been validated by TTE, there remains a question as to the validity or precision of TEE-derived measurements.

Conditions: Ventricular Function, Right, Echocardiography, Transesophageal
Being tested: Transesophageal Echocardiography, Transthoracic Echocardiography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transesophageal EchocardiographyDiagnostic test
Also called TEE
TEE measures of right ventricular function
Transthoracic EchocardiographyDiagnostic test
Also called TTE
TTE measures of right ventricular function

What is being measured

The primary outcome is the main question the study is designed to answer.

Right ventricular index of myocardial performance (RIMP)
Right ventricular index of myocardial performance (RIMP) will be measured using both TTE and TEE.
Measured: Immediately following the induction of anesthesia and TEE probe placement
Tricuspid annular plane systolic excursion (TAPSE)
Tricuspid annular plane systolic excursion (TAPSE) will be measured using both TTE and TEE.
Measured: Immediately following the induction of anesthesia and TEE probe placement
Right ventricular fractional area change (FAC)
Right ventricular fractional area change (FAC) will be measured using both TTE and TEE.
Measured: Immediately following the induction of anesthesia and TEE probe placement
RV annular systolic velocity (S')
RV annular systolic velocity (S') will be measured using both TTE and TEE.
Measured: Immediately following the induction of anesthesia and TEE probe placement
RV free wall longitudinal strain
RV free wall longitudinal strain will be measured using both TTE and TEE.
Measured: Immediately following the induction of anesthesia and TEE probe placement

Secondary outcomes (2)

Ease of obtaining appropriate TEE measures of right ventricular function
Ease of acquisition will be assessed by the echocardiographers
Measured: Within 15 minutes following anesthesia induction
Define values for normal right ventricular free wall strain
The data collected will be used to define normal values for right ventricular free wall strain
Measured: Through study completion, an estimate of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Sep 201710 Oct 2018

First posted29 Aug 2017
Study start18 Sep 2017
Primary completion10 Oct 2018
Study completion10 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (28)Papers the sponsor has linked to this study.
Other trials for Ventricular Function, RightStudies 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: 126 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03264183
Sponsor's protocol ID: STUDY00007541
Acronym: TEE
Status last verified: Jun 2019
First submitted: 26 Jul 2017
Last updated: 24 Jun 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Barakat AF, Sperry BW, Starling RC, Mentias A, Popovic ZB, Griffin BP, Desai MY. Prognostic Utility of Right Ventricular Free Wall Strain in Low Risk Patients After Orthotopic Heart Transplantation. Am J Cardiol. 2017 Jun 1;119(11):1890-1896. doi: 10.1016/j.amjcard.2017.03.003. Epub 2017 Mar 15.
PubMed 28390683
Bellavia D, Iacovoni A, Scardulla C, Moja L, Pilato M, Kushwaha SS, Senni M, Clemenza F, Agnese V, Falletta C, Romano G, Maalouf J, Dandel M. Prediction of right ventricular failure after ventricular assist device implant: systematic review and meta-analysis of observational studies. Eur J Heart Fail. 2017 Jul;19(7):926-946. doi: 10.1002/ejhf.733. Epub 2017 Mar 31.
PubMed 28371221
Howard-Quijano K, Salem A, Barkulis C, Mazor E, Scovotti JC, Ho JK, Shemin RJ, Grogan T, Elashoff D, Mahajan A. Preoperative Three-Dimensional Strain Imaging Identifies Reduction in Left Ventricular Function and Predicts Outcomes After Cardiac Surgery. Anesth Analg. 2017 Feb;124(2):419-428. doi: 10.1213/ANE.0000000000001440.
PubMed 27782943
Kemal HS, Kayikcioglu M, Kultursay H, Vuran O, Nalbantgil S, Mogulkoc N, Can L. Right ventricular free-wall longitudinal speckle tracking strain in patients with pulmonary arterial hypertension under specific treatment. Echocardiography. 2017 Apr;34(4):530-536. doi: 10.1111/echo.13472. Epub 2017 Mar 23.
PubMed 28332221
Peyrou J, Chauvel C, Pathak A, Simon M, Dehant P, Abergel E. Preoperative right ventricular dysfunction is a strong predictor of 3 years survival after cardiac surgery. Clin Res Cardiol. 2017 Sep;106(9):734-742. doi: 10.1007/s00392-017-1117-y. Epub 2017 Apr 13.
PubMed 28409231
Sokalskis V, Peluso D, Jagodzinski A, Sinning C. Added clinical value of applying myocardial deformation imaging to assess right ventricular function. Echocardiography. 2017 Jun;34(6):919-927. doi: 10.1111/echo.13521. Epub 2017 Mar 19.
PubMed 28317170
Tousignant C, Desmet M, Bowry R, Harrington AM, Cruz JD, Mazer CD. Speckle tracking for the intraoperative assessment of right ventricular function: a feasibility study. J Cardiothorac Vasc Anesth. 2010 Apr;24(2):275-9. doi: 10.1053/j.jvca.2009.10.022. Epub 2010 Jan 6.
PubMed 20056440
Agac MT, Akyuz AR, Acar Z, Akdemir R, Korkmaz L, Kiris A, Erkus E, Erkan H, Celik S. Evaluation of right ventricular function in early period following transcatheter closure of atrial septal defect. Echocardiography. 2012 Mar;29(3):358-62. doi: 10.1111/j.1540-8175.2011.01558.x. Epub 2011 Nov 8.
PubMed 22066780
Akiyama K, Arisawa S, Ide M, Iwaya M, Naito Y. Intraoperative cardiac assessment with transesophageal echocardiography for decision-making in cardiac anesthesia. Gen Thorac Cardiovasc Surg. 2013 Jun;61(6):320-9. doi: 10.1007/s11748-013-0208-6. Epub 2013 Feb 13.
PubMed 23404310
Carerj S, Micari A, Trono A, Giordano G, Cerrito M, Zito C, Luzza F, Coglitore S, Arrigo F, Oreto G. Anatomical M-mode: an old-new technique. Echocardiography. 2003 May;20(4):357-61. doi: 10.1046/j.1540-8175.2003.03041.x.
PubMed 12848879
Chan J, Wahi S, Cain P, Marwick TH. Anatomical M-mode: A novel technique for the quantitative evaluation of regional wall motion analysis during dobutamine echocardiography. Int J Card Imaging. 2000 Aug;16(4):247-55. doi: 10.1023/a:1026539708034.
PubMed 11219596
David JS, Tousignant CP, Bowry R. Tricuspid annular velocity in patients undergoing cardiac operation using transesophageal echocardiography. J Am Soc Echocardiogr. 2006 Mar;19(3):329-34. doi: 10.1016/j.echo.2005.09.013.
PubMed 16500497
Hahn RT, Abraham T, Adams MS, Bruce CJ, Glas KE, Lang RM, Reeves ST, Shanewise JS, Siu SC, Stewart W, Picard MH. Guidelines for performing a comprehensive transesophageal echocardiographic examination: recommendations from the American Society of Echocardiography and the Society of Cardiovascular Anesthesiologists. J Am Soc Echocardiogr. 2013 Sep;26(9):921-64. doi: 10.1016/j.echo.2013.07.009. No abstract available.
PubMed 23998692
Ito S, Pislaru SV, Soo WM, Huang R, Greason KL, Mathew V, Sandhu GS, Eleid MF, Suri RM, Oh JK, Nkomo VT. Impact of right ventricular size and function on survival following transcatheter aortic valve replacement. Int J Cardiol. 2016 Oct 15;221:269-74. doi: 10.1016/j.ijcard.2016.07.085. Epub 2016 Jul 6.
PubMed 27404688
Magunia H, Schmid E, Hilberath JN, Haberle L, Grasshoff C, Schlensak C, Rosenberger P, Nowak-Machen M. 2D Echocardiographic Evaluation of Right Ventricular Function Correlates With 3D Volumetric Models in Cardiac Surgery Patients. J Cardiothorac Vasc Anesth. 2017 Apr;31(2):595-601. doi: 10.1053/j.jvca.2016.11.020. Epub 2016 Nov 14.
PubMed 28129939

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
Active, not recruiting
Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE)
Pulmonary Arterial Hypertension, Insulin Resistance
Enrolling by invitationPhase 3
A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
PAH, Pulmonary Hypertension
Not yet recruitingObservational study
Right Heart and Lung Blood Flow During Exercise (RIGHT-NET 2.0)
Right Ventricular Dysfunction, Cardiopulmonary Diseases

All Ventricular Function, Right trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Validating Transesophageal Echocardiographic Measurements of Right Ventricular Function
ClinicalTrials.gov ID: NCT03264183
Acronym / sponsor ID: TEE / STUDY00007541
Conditions: Ventricular Function, Right, Echocardiography, Transesophageal
Study type: Observational
Recruitment status: Completed
Enrolment: 126 participants (actual)
Lead sponsor: Milton S. Hershey Medical CenterUniversity, hospital or other
Study start: 18 Sep 2017 (actual)
Primary completion: 10 Oct 2018 (actual)
Study completion: 10 Oct 2018 (actual)
First posted: 29 Aug 2017 (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.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All patients undergoing elective cardiac surgery, which as a standard of care, requires transesophageal echocardiography.

Key inclusion criteria (1 listed)

Adult patients undergoing elective cardiac surgery requiring TEE

Key exclusion criteria (8 listed)

Patient who do not wish to consent
Patients with contraindications to TEE
Urgent or emergent cardiac surgery
Patients with preexisting open chest
Patients with intrathoracic hardware (VAD, thoracostomy tube, etc)

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
Transesophageal EchocardiographyAlso: TEETEE measures of right ventricular function	Diagnostic test	–
Transthoracic EchocardiographyAlso: TTETTE measures of right ventricular function	Diagnostic test	–

Primary outcome

Right ventricular index of myocardial performance (RIMP)
Time frame: Immediately following the induction of anesthesia and TEE probe placement
Right ventricular index of myocardial performance (RIMP) will be measured using both TTE and TEE.
Tricuspid annular plane systolic excursion (TAPSE)
Time frame: Immediately following the induction of anesthesia and TEE probe placement
Tricuspid annular plane systolic excursion (TAPSE) will be measured using both TTE and TEE.
Right ventricular fractional area change (FAC)
Time frame: Immediately following the induction of anesthesia and TEE probe placement
Right ventricular fractional area change (FAC) will be measured using both TTE and TEE.
RV annular systolic velocity (S')
Time frame: Immediately following the induction of anesthesia and TEE probe placement
RV annular systolic velocity (S') will be measured using both TTE and TEE.
RV free wall longitudinal strain
Time frame: Immediately following the induction of anesthesia and TEE probe placement
RV free wall longitudinal strain will be measured using both TTE and TEE.

2 secondary outcomes

Ease of obtaining appropriate TEE measures of right ventricular function
Time frame: Within 15 minutes following anesthesia induction
Define values for normal right ventricular free wall strain
Time frame: Through study completion, an estimate of 1 year

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 24 Jun 2019.
Background: PubMed 28390683Barakat AF, Sperry BW, Starling RC, Mentias A, Popovic ZB, Griffin BP, Desai MY. Prognostic Utility of Right Ventricular Free Wall Strain in Low Risk Patients After Orthotopic Heart Transplantation. Am J Cardiol. 2017 Jun 1;119(11):1890-1896. doi: 10.1016/j.amjcard.2017.03.003. Epub 2017 Mar 15.
Background: PubMed 28371221Bellavia D, Iacovoni A, Scardulla C, Moja L, Pilato M, Kushwaha SS, Senni M, Clemenza F, Agnese V, Falletta C, Romano G, Maalouf J, Dandel M. Prediction of right ventricular failure after ventricular assist device implant: systematic review and meta-analysis of observational studies. Eur J Heart Fail. 2017 Jul;19(7):926-946. doi: 10.1002/ejhf.733. Epub 2017 Mar 31.
Background: PubMed 27782943Howard-Quijano K, Salem A, Barkulis C, Mazor E, Scovotti JC, Ho JK, Shemin RJ, Grogan T, Elashoff D, Mahajan A. Preoperative Three-Dimensional Strain Imaging Identifies Reduction in Left Ventricular Function and Predicts Outcomes After Cardiac Surgery. Anesth Analg. 2017 Feb;124(2):419-428. doi: 10.1213/ANE.0000000000001440.
Background: PubMed 28332221Kemal HS, Kayikcioglu M, Kultursay H, Vuran O, Nalbantgil S, Mogulkoc N, Can L. Right ventricular free-wall longitudinal speckle tracking strain in patients with pulmonary arterial hypertension under specific treatment. Echocardiography. 2017 Apr;34(4):530-536. doi: 10.1111/echo.13472. Epub 2017 Mar 23.
Background: PubMed 28409231Peyrou J, Chauvel C, Pathak A, Simon M, Dehant P, Abergel E. Preoperative right ventricular dysfunction is a strong predictor of 3 years survival after cardiac surgery. Clin Res Cardiol. 2017 Sep;106(9):734-742. doi: 10.1007/s00392-017-1117-y. Epub 2017 Apr 13.
Background: PubMed 28317170Sokalskis V, Peluso D, Jagodzinski A, Sinning C. Added clinical value of applying myocardial deformation imaging to assess right ventricular function. Echocardiography. 2017 Jun;34(6):919-927. doi: 10.1111/echo.13521. Epub 2017 Mar 19.
Background: PubMed 20056440Tousignant C, Desmet M, Bowry R, Harrington AM, Cruz JD, Mazer CD. Speckle tracking for the intraoperative assessment of right ventricular function: a feasibility study. J Cardiothorac Vasc Anesth. 2010 Apr;24(2):275-9. doi: 10.1053/j.jvca.2009.10.022. Epub 2010 Jan 6.
Background: PubMed 22066780Agac MT, Akyuz AR, Acar Z, Akdemir R, Korkmaz L, Kiris A, Erkus E, Erkan H, Celik S. Evaluation of right ventricular function in early period following transcatheter closure of atrial septal defect. Echocardiography. 2012 Mar;29(3):358-62. doi: 10.1111/j.1540-8175.2011.01558.x. Epub 2011 Nov 8.
Background: PubMed 23404310Akiyama K, Arisawa S, Ide M, Iwaya M, Naito Y. Intraoperative cardiac assessment with transesophageal echocardiography for decision-making in cardiac anesthesia. Gen Thorac Cardiovasc Surg. 2013 Jun;61(6):320-9. doi: 10.1007/s11748-013-0208-6. Epub 2013 Feb 13.
Background: PubMed 12848879Carerj S, Micari A, Trono A, Giordano G, Cerrito M, Zito C, Luzza F, Coglitore S, Arrigo F, Oreto G. Anatomical M-mode: an old-new technique. Echocardiography. 2003 May;20(4):357-61. doi: 10.1046/j.1540-8175.2003.03041.x.
Background: PubMed 11219596Chan J, Wahi S, Cain P, Marwick TH. Anatomical M-mode: A novel technique for the quantitative evaluation of regional wall motion analysis during dobutamine echocardiography. Int J Card Imaging. 2000 Aug;16(4):247-55. doi: 10.1023/a:1026539708034.
Background: PubMed 16500497David JS, Tousignant CP, Bowry R. Tricuspid annular velocity in patients undergoing cardiac operation using transesophageal echocardiography. J Am Soc Echocardiogr. 2006 Mar;19(3):329-34. doi: 10.1016/j.echo.2005.09.013.
Individual participant dataSharing planned: No

Related trials for Ventricular Function, Right

RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
Active, not recruiting
Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE)
Pulmonary Arterial Hypertension, Insulin Resistance
Enrolling by invitationPhase 3
A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
PAH, Pulmonary Hypertension
Not yet recruitingObservational study
Right Heart and Lung Blood Flow During Exercise (RIGHT-NET 2.0)
Right Ventricular Dysfunction, Cardiopulmonary Diseases

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.

Shayne M Roberts, DO principal investigator

Milton S. Hershey Medical Center

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 Ventricular Function, Right and Echocardiography, Transesophageal, run by Milton S. Hershey Medical Center at 1 site in United States.

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 1 inclusion and 8 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 24 Jun 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 States. 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?

Right ventricular index of myocardial performance (RIMP) (time frame: Immediately following the induction of anesthesia and TEE probe placement). The study lists 5 primary outcomes in all. 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 NCT03264183, which also lists 28 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 24 Jun 2019.