The Relationship Between TAPSE Value and Volume(TAPSE)NCT06105866
Relationship of Preoperative Fasting With Tricuspid Annular Plane Systolic Excursion
An observational study of The Relationship Between TAPSE Value and Volume, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to try to establish a relationship between preoperative fasting-related volume changes and tricuspid annular plane systolic excursion (TAPSE), and to determine whether there are changes in right ventricular functions due to preoperative fasting. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- The Relationship Between TAPSE Value and Volume
- What is being tested?
- Tricuspid Annular Plane Systolic Excursion
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Feb 2024to 5 Dec 2024
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients scheduled for surgery who have applied to Adnan Menderes University Hospital
Who may be able to join
- ASA 1-2-3
- The patient must be between 18 and 75 years old.
- Perioperative hydration has not been administered.
- Preoperative sedatives have not been given.
- There should be no known heart disease.
Who cannot join
- The patient being pregnant
- Post-cardiac surgery
- Severe pulmonary hypertension
- Severe valve disease
- Hypertrophic or dilated cardiomyopathy
- Presence of acute myocardial infarction
- Non-sinus rhythm
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Relationship of Preoperative Fasting With Tricuspid Annular Plane Systolic Excursion (TAPSE)
The aim of our study is to try to establish a relationship between preoperative fasting-related volume changes and tricuspid annular plane systolic excursion (TAPSE), and to determine whether there are changes in right ventricular functions due to preoperative fasting.
Read the detailed description
TAPSE (Tricuspid Annular Plane Systolic Excursion) is a parameter that easily measures apex-base shortening and provides specific information about global right ventricular (RV) function. It is less dependent on optimal image quality and serves as an easily measurable criterion compared to other RV function measurements. In this study, one day before the operation, transthoracic echocardiography (TTE) will be conducted on fasting patients, and if the preoperative fasting duration is appropriate on the day of the surgery, TTE measurements will be repeated and recorded. The study aims to evaluate the relationship between TAPSE and volume and determine whether there are any changes in right ventricular functions due to preoperative fasting.
- Being tested
- Tricuspid Annular Plane Systolic Excursion
- Keywords
- Tricuspid Annular Plane Systolic Excursion, Preoperative Fasting, Right ventricular functions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tricuspid Annular Plane Systolic ExcursionDiagnostic test
Transthoracic echocardiography will be performed on patients during hospitalization and preoperatively to investigate the relationship between preoperative fasting and right ventricular functions. This will be examined by looking at TAPSE
| Study group | Role | What they receive |
|---|---|---|
| Patients without Cardiac Disease | Patients between the ages of 18-75 with sinus rhythm, and without valvular disease, pulmonary hypertension, acute myocardial infarction, dilated, and hypertrophic cardiomyopathy will be included in the study. Receives: Diagnostic Test: Tricuspid Annular Plane Systolic Excursion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The TAPSE value is related to volume
We will measure FAC, S' velocity, TAPSE, and Myocardial Performance Index (MPI) derived from TDI to evaluate Right Ventricular (RV) systolic functions. To assess the RV diastolic function, we will measure Tricuspid E and A wave velocities, E/A ratio, and E' velocity. TAPSE will be calculated by placing an M-mode cursor along the Tricuspid Annulus and measuring the longitudinal excursion during peak systole
Measured: Patients who apply to our hospital for surgery within 6 months will be included in our study. Preoperative TAPSE measurements will be taken from the patients twice, first during admission and immediately before the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start11 Feb 2024
- Primary completion5 Dec 2024 (estimated)
- Study completion5 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for The Relationship Between TAPSE Value and VolumeStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ferdi gülaştı, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105866
- Sponsor's protocol ID
- NCT093509350935
- Acronym
- (TAPSE)
- Status last verified
- Dec 2024
- First submitted
- 19 Oct 2023
- Last updated
- 4 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the end of the study, the results of the statistical analysis of all collected data will be shared.
Publications
Lee S, Kamdar F, Madlon-Kay R, Boyle A, Colvin-Adams M, Pritzker M, John R. Effects of the HeartMate II continuous-flow left ventricular assist device on right ventricular function. J Heart Lung Transplant. 2010 Feb;29(2):209-15. doi: 10.1016/j.healun.2009.11.599.
PubMed 20113911Gullupinar B, Saglam C, Koran S, Turhan A, Unluer EE. The role of mitral annular plane systolic excursion in prediction of acute blood loss in healthy voluntary blood donors. J Ultrason. 2022 Feb 8;22(88):e33-e38. doi: 10.15557/JoU.2022.0006. eCollection 2022 Mar.
PubMed 35449700Zhang H, Wang X, Chen X, Zhang Q, Liu D. Tricuspid annular plane systolic excursion and central venous pressure in mechanically ventilated critically ill patients. Cardiovasc Ultrasound. 2018 Aug 7;16(1):11. doi: 10.1186/s12947-018-0130-2.
PubMed 30081914Newman K, Wilson R, Roberts JM, Mayo JR, Mohamed Ali AA, Brunner N, Sedlic A. Tricuspid annular plane systolic excursion for the evaluation of right ventricular function in functional cardiac CT compared to MRI. Clin Radiol. 2021 Aug;76(8):628.e1-628.e7. doi: 10.1016/j.crad.2021.02.018. Epub 2021 Apr 18.
PubMed 33879320
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Preoperative Fasting With Tricuspid Annular Plane Systolic Excursion (TAPSE)
- ClinicalTrials.gov ID
- NCT06105866
- Acronym / sponsor ID
- (TAPSE) / NCT093509350935
- Keywords
- Tricuspid Annular Plane Systolic Excursion, Preoperative Fasting, Right ventricular functions
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 11 Feb 2024 (actual)
- Primary completion
- 5 Dec 2024 (estimated)
- Study completion
- 5 Dec 2024 (estimated)
- First posted
- 30 Oct 2023 (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 our study is to try to establish a relationship between preoperative fasting-related volume changes and tricuspid annular plane systolic excursion (TAPSE), and to determine whether there are changes in right ventricular functions due to preoperative fasting.
Detailed description
TAPSE (Tricuspid Annular Plane Systolic Excursion) is a parameter that easily measures apex-base shortening and provides specific information about global right ventricular (RV) function. It is less dependent on optimal image quality and serves as an easily measurable criterion compared to other RV function measurements. In this study, one day before the operation, transthoracic echocardiography (TTE) will be conducted on fasting patients, and if the preoperative fasting duration is appropriate on the day of the surgery, TTE measurements will be repeated and recorded. The study aims to evaluate the relationship between TAPSE and volume and determine whether there are any changes in right ventricular functions due to preoperative fasting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients without Cardiac Disease | – | Diagnostic Test: Tricuspid Annular Plane Systolic ExcursionPatients between the ages of 18-75 with sinus rhythm, and without valvular disease, pulmonary hypertension, acute myocardial infarction, dilated, and hypertrophic cardiomyopathy will be included in the study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for surgery who have applied to Adnan Menderes University Hospital
Key inclusion criteria (5 listed)
- ASA 1-2-3
- The patient must be between 18 and 75 years old.
- Perioperative hydration has not been administered.
- Preoperative sedatives have not been given.
- There should be no known heart disease.
Key exclusion criteria (7 listed)
- The patient being pregnant
- Post-cardiac surgery
- Severe pulmonary hypertension
- Severe valve disease
- Hypertrophic or dilated cardiomyopathy
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 |
|---|---|---|
| Tricuspid Annular Plane Systolic ExcursionTransthoracic echocardiography will be performed on patients during hospitalization and preoperatively to investigate the relationship between preoperative fasting and right ventricular functions. This will be examined by looking at TAPSE | Diagnostic test | Patients without Cardiac Disease |
Primary outcome
The TAPSE value is related to volume
Time frame: Patients who apply to our hospital for surgery within 6 months will be included in our study. Preoperative TAPSE measurements will be taken from the patients twice, first during admission and immediately before the operation
We will measure FAC, S' velocity, TAPSE, and Myocardial Performance Index (MPI) derived from TDI to evaluate Right Ventricular (RV) systolic functions. To assess the RV diastolic function, we will measure Tricuspid E and A wave velocities, E/A ratio, and E' velocity. TAPSE will be calculated by placing an M-mode cursor along the Tricuspid Annulus and measuring the longitudinal excursion during peak systole
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Background: PubMed 20113911Lee S, Kamdar F, Madlon-Kay R, Boyle A, Colvin-Adams M, Pritzker M, John R. Effects of the HeartMate II continuous-flow left ventricular assist device on right ventricular function. J Heart Lung Transplant. 2010 Feb;29(2):209-15. doi: 10.1016/j.healun.2009.11.599.
- Background: PubMed 35449700Gullupinar B, Saglam C, Koran S, Turhan A, Unluer EE. The role of mitral annular plane systolic excursion in prediction of acute blood loss in healthy voluntary blood donors. J Ultrason. 2022 Feb 8;22(88):e33-e38. doi: 10.15557/JoU.2022.0006. eCollection 2022 Mar.
- Background: PubMed 30081914Zhang H, Wang X, Chen X, Zhang Q, Liu D. Tricuspid annular plane systolic excursion and central venous pressure in mechanically ventilated critically ill patients. Cardiovasc Ultrasound. 2018 Aug 7;16(1):11. doi: 10.1186/s12947-018-0130-2.
- Background: PubMed 33879320Newman K, Wilson R, Roberts JM, Mayo JR, Mohamed Ali AA, Brunner N, Sedlic A. Tricuspid annular plane systolic excursion for the evaluation of right ventricular function in functional cardiac CT compared to MRI. Clin Radiol. 2021 Aug;76(8):628.e1-628.e7. doi: 10.1016/j.crad.2021.02.018. Epub 2021 Apr 18.
- Individual participant dataSharing planned: Yes. At the end of the study, the results of the statistical analysis of all collected data will be shared.
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.
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 The Relationship Between TAPSE Value and Volume, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
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 5 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 4 Dec 2024. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
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?
The TAPSE value is related to volume (time frame: Patients who apply to our hospital for surgery within 6 months will be included in our study. Preoperative TAPSE measurements will be taken from the patients twice, first during admission and immediately before the operation). 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 NCT06105866, which also lists 4 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 4 Dec 2024.