Right Heart DysfunctionTAPSENCT03649854
Measurement of Tricuspid AnnularPlane Systolic Excursion in Transesophageal Echocardiography
An observational study of Right Heart Dysfunction, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
The aim of this study is to measure TAPSE in TEE using two deep transgastric views. This is a prospective comparative diagnostic study where 21 CABG patients who are enrolled for the study will be studied during the intraoperative period. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Right Heart Dysfunction
- How many people
- 26 participants
- Where
- 1 siteSingapore
- Study dates
- 15 Aug 2014to 14 Aug 2015
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for coronary artery bypass surgery at National university hospital are included in the study
Who may be able to join
- Ejection fraction greater than 40% No other valvular involvement other than mild mitral regurgitation
Who cannot join
- Hemodynamically unstable patients
- Intubated and sedated patients
- Emergency patients from cath lab
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measurement of Tricuspid Annular Plane Systolic Excursion in Transesophageal Echocardiography Using Two Deep Transgastric Views
The aim of this study is to measure TAPSE in TEE using two deep transgastric views. This is a prospective comparative diagnostic study where 21 CABG patients who are enrolled for the study will be studied during the intraoperative period. The choice of general anaesthesia, hemodynamic management will be at the discretion of the anaesthesiologist in charge of the patient. The monitoring technique is standard as per any cardiac surgery with cardiopulmonary bypass. After induction of anaesthesia, TEE probe will be inserted by the PI or the Co-Investigator and the required TEE standard views and deep TG view of the right heart at zero degree and Deep TG view at 100-150 degrees will be acquired TAPSE will be measured in both the views using Mmode.
The measurement will be done as follows: After acquiring the deep TG views the M mode cursor is aligned with the longitudinal motion the lateral tricuspid annulus. Once the Mmode picks up a good signal, 3 cycles are chosen and measured using calipers, and an average reading is taken. TAPSE will be used to evaluate the right heart function during the intraoperative period so that the patients with deteriorating right heart function can be identified and treatment started early. The potential benefits include the simplicity and reproducibility of the technique.
Read the detailed description
Right ventricular failure(RVF) is an important cause of postoperative morbidity and mortality after cardiac surgery. Severe refractory RVF requiring prolonged inotropic support or RV assist device occurs in approximately 0.1% of patients after cardiotomy and in 20-30% of patients after left ventricular failure. The survival rate in these patients may be as low as 25 to 30%. Early diagnosis and prompt instituition of therapy may improve survival. In the intraoperative setting TEE is becoming the mainstay in the assessment of right ventricular function. However, presently it is not systematic and objective assessment of RV is not uniformly carried out. This is partly due to the enormous attention given to the evaluation of the left ventricle and the echo challenges of right heart imaging during intraoperative period.
In 2010 the ASE released the guidelines on Right heart. It recommends Fractional Area change, Tricuspid Annular Plane Systolic Excursion(TAPSE) and Peak Systolic tissue velocity of tricuspid annulus as simple reproducible measurements that can be done in all the patients. The guidelines are based on Transthoracic Echocardiography measurements. The Transesophageal echocardiography which is used during cardiac surgery poses unique challenges when assessing the right heart. The right ventricle lies in the far field where the resolution is not good, and is made worse by the extensive apical trabeculations ; these factors make endocardial border tracing difficult. In addition, the tissue Doppler and M mode alignment of the tricuspid annulus is not possible in the mid oesophageal views. Recently, a deep trans gastric view more than 120-150 degrees has been suggested by Denault et al which would give an alignment for tissue and pulse wave Doppler but TAPSE hasn't been studied using this view. The investigators have found a novel Deep trans gastric right heart view at zero degrees , which provides a good alignment for Doppler and M mode from which TAPSE, Peak systolic tissue velocity of the Tricuspid annulus, and Right ventricular performance index can be readily measured. We believe that this single view which can be easily acquired in most patients can comprehensively assess the systolic and diastolic function of the right heart during the intraoperative period.
The investigators propose that TAPSE can be accurately measured using M mode in the deep transgastric right heart view at zero degrees because it provides perfect alignment with longitudinal excursion of the lateral tricuspid annulus. Since the frame rate of M mode is very high, distance can be more accurately measured than any other technique.
The aim of this study is to compare TAPSE measurement using Mmode in the two Deep transgastric views: Deep TG view at 120- 150 degrees
- Conditions
- Right Heart Dysfunction
- Keywords
- TAPSE, Right heart function
What is being measured
The primary outcome is the main question the study is designed to answer.
New method for assessing right heart function
TAPSE mesurement using M mode in the deep transgastric right heart view at zero degrees
Measured: During systole intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start15 Aug 2014
- Primary completion23 Mar 2015
- Study completion14 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right Heart DysfunctionStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anaesthesia, National University Hospital, Singapore
- Investigators
- Lalitha Manickam, Principal investigator, NUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649854
- Sponsor's protocol ID
- 2014/00576
- Other IDs
- 2014
- Acronym
- TAPSE
- Status last verified
- Aug 2018
- First submitted
- 23 Aug 2018
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Tricuspid Annular Plane Systolic Excursion in Transesophageal Echocardiography Using Two Deep Transgastric Views
- ClinicalTrials.gov ID
- NCT03649854
- Acronym / sponsor ID
- TAPSE / 2014/00576
- Conditions
- Right Heart Dysfunction
- Keywords
- TAPSE, Right heart function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 15 Aug 2014 (actual)
- Primary completion
- 23 Mar 2015 (actual)
- Study completion
- 14 Aug 2015 (actual)
- First posted
- 28 Aug 2018 (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.
The aim of this study is to measure TAPSE in TEE using two deep transgastric views. This is a prospective comparative diagnostic study where 21 CABG patients who are enrolled for the study will be studied during the intraoperative period. The choice of general anaesthesia, hemodynamic management will be at the discretion of the anaesthesiologist in charge of the patient. The monitoring technique is standard as per any cardiac surgery with cardiopulmonary bypass. After induction of anaesthesia, TEE probe will be inserted by the PI or the Co-Investigator and the required TEE standard views and deep TG view of the right heart at zero degree and Deep TG view at 100-150 degrees will be acquired TAPSE will be measured in both the views using Mmode.
The measurement will be done as follows: After acquiring the deep TG views the M mode cursor is aligned with the longitudinal motion the lateral tricuspid annulus. Once the Mmode picks up a good signal, 3 cycles are chosen and measured using calipers, and an average reading is taken. TAPSE will be used to evaluate the right heart function during the intraoperative period so that the patients with deteriorating right heart function can be identified and treatment started early. The potential benefits include the simplicity and reproducibility of the technique.
Detailed description
Right ventricular failure(RVF) is an important cause of postoperative morbidity and mortality after cardiac surgery. Severe refractory RVF requiring prolonged inotropic support or RV assist device occurs in approximately 0.1% of patients after cardiotomy and in 20-30% of patients after left ventricular failure. The survival rate in these patients may be as low as 25 to 30%. Early diagnosis and prompt instituition of therapy may improve survival. In the intraoperative setting TEE is becoming the mainstay in the assessment of right ventricular function. However, presently it is not systematic and objective assessment of RV is not uniformly carried out. This is partly due to the enormous attention given to the evaluation of the left ventricle and the echo challenges of right heart imaging during intraoperative period.
In 2010 the ASE released the guidelines on Right heart. It recommends Fractional Area change, Tricuspid Annular Plane Systolic Excursion(TAPSE) and Peak Systolic tissue velocity of tricuspid annulus as simple reproducible measurements that can be done in all the patients. The guidelines are based on Transthoracic Echocardiography measurements. The Transesophageal echocardiography which is used during cardiac surgery poses unique challenges when assessing the right heart. The right ventricle lies in the far field where the resolution is not good, and is made worse by the extensive apical trabeculations ; these factors make endocardial border tracing difficult. In addition, the tissue Doppler and M mode alignment of the tricuspid annulus is not possible in the mid oesophageal views. Recently, a deep trans gastric view more than 120-150 degrees has been suggested by Denault et al which would give an alignment for tissue and pulse wave Doppler but TAPSE hasn't been studied using this view. The investigators have found a novel Deep trans gastric right heart view at zero degrees , which provides a good alignment for Doppler and M mode from which TAPSE, Peak systolic tissue velocity of the Tricuspid annulus, and Right ventricular performance index can be readily measured. We believe that this single view which can be easily acquired in most patients can comprehensively assess the systolic and diastolic function of the right heart during the intraoperative period.
The investigators propose that TAPSE can be accurately measured using M mode in the deep transgastric right heart view at zero degrees because it provides perfect alignment with longitudinal excursion of the lateral tricuspid annulus. Since the frame rate of M mode is very high, distance can be more accurately measured than any other technique.
The aim of this study is to compare TAPSE measurement using Mmode in the two Deep transgastric views: Deep TG view at 120- 150 degrees
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for coronary artery bypass surgery at National university hospital are included in the study
Key inclusion criteria (1 listed)
- Ejection fraction greater than 40% No other valvular involvement other than mild mitral regurgitation
Key exclusion criteria (3 listed)
- Hemodynamically unstable patients
- Intubated and sedated patients
- Emergency patients from cath lab
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
New method for assessing right heart function
Time frame: During systole intraoperatively
TAPSE mesurement using M mode in the deep transgastric right heart view at zero degrees
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 28 Aug 2018.
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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.
Lalitha Manickam principal investigator
NUH
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 Right Heart Dysfunction, run by National University Hospital, Singapore at 1 site in Singapore.
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 3 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 28 Aug 2018. 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 Singapore. 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?
New method for assessing right heart function (time frame: During systole intraoperatively). It is what the study was designed to measure, not a finding.
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 28 Aug 2018.