Relationship of Preoperative Fasting With Tricuspid Annular Plane Systolic Excursion ((TAPSE))

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: The Relationship Between TAPSE Value and Volume
• Intervention / Treatment: Diagnostic test: Tricuspid Annular Plane Systolic Excursion

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Turkey
  • Zafer
    • Aydın, Zafer, Turkey, 09010
      • Sevil Gulasti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for surgery who have applied to Adnan Menderes University Hospital

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Tricuspid Annular Plane Systolic Excursion; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University

Publications and helpful links

General 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.
• Gullupinar 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.
• Zhang 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.
• Newman 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2024
• Primary Completion (Estimated): December 5, 2024
• Study Completion (Estimated): December 5, 2024

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: December 1, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Preoperative Fasting; Tricuspid Annular Plane Systolic Excursion; Right ventricular functions
• Additional Relevant MeSH Terms: Heart Murmurs; Systolic Murmurs
• Other Study ID Numbers: NCT093509350935

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: At the end of the study, the results of the statistical analysis of all collected data will be shared.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No