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

December 1, 2024 updated by: ferdi gülaştı, Aydin Adnan Menderes University

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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aydin Adnan Menderes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 11, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 5, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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