Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction ((Tapse))

October 18, 2020 updated by: Ferdi GÜLAŞTI, Bursa City Hospital
the investigators purpose is to predict hypotensive condition that can develop after general anesthesia induction by measuring the Tricuspid Annular Plane Systolic Movement (TAPSE), which is an echocardiographic parameter.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

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Detailed Description

Intraoperative hypotension development might increase myocardial damage, acute kidney damage, and septic complications, and have an effect on mortality increase. For this reason, prevention of an unwanted hypotensive event has an important role in reducing mortality and morbidity. The prediction of the risk of hypotension is generally based on the evaluation of the comorbid status and volume status of patients .It is already known that right ventricular systolic dysfunction has prognostic value in various pathological cases. It is quite difficult to evaluate the RV function with echocardiography because of the complex geometry of RV. Although RV function has been evaluated only visually for many years, guidelines have been published as a result of recent studies by the American Society of Echocardiography. In this respect, abnormal RV function should be suspected when one of the criteria of S '<10 cm /s, TAPSE <16 mm, RVFAC <35%, or R-MPI (Tissue Doppler)> 0.55. Normal and abnormal function is distinguished more reliably when combining more than one RV function measures. TAPSE is a parameter with which the apex-basal shortening can be easily measured, providing specific data on global RV function. It depends less on optimal image quality than other RV function measurements, and is an easy-to-measure criterion. Low TAPSE is not very common; however, it was measured in people with no heart disease due to diagnostic misclassification and excessive ends of the normal spectrum. the investigators think that despite the lack of cardiac disease, cardiac reserve functions of each patient may have limits in terms of development of hypotension in general anesthesia induction. The investigators considered that TAPSE, which decreased within normal limits in patients without cardiac disease, could predict hypotension development in general anesthesia induction, and planned study for this purpose.

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 (Anticipated)

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.
7

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
      • Bursa, Turkey
        • Bursa City Hospital

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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

It was planned that a total of 40 patients undergoing elective general surgery under general anesthesia with standard general anesthesia induction would be included in this prospective and observational study.

Description

Inclusion Criteria:

  • Patients scheduled for elective surgery
  • Patients who will receive general anesthesia
  • Patients between 18-65 years of age
  • Physical status I or II according to the American Society of Anesthetists (ASA) in preoperative evaluation
  • Those without known heart disease
  • Patients with TAPSE value above 1.6 cm

Exclusion Criteria:

  • Patients under the age of 8 and over 65,
  • Pregnant patients,
  • Patients who refuse to participate in the study,
  • ASA III and above,
  • Patients with known heart disease,
  • Patients with TAPSE value of less than 1.6 measured with Transthoracic Echocardiography will not be allowed to be included in the study.
  • Patients with difficult airway management or difficult intubation will be excluded from the study.

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.
hypotension
Basal hemodynamic parameters and hemodynamic values will be taken every two minutes after induction until surgical incision. Patients with systolic pressure <90 mmHg or 30% drop in baseline, and mean artery pressure below 60 mmHg will be considered to have hypotension. Patients will be divided into two groups as "Hypotension" and "No Hypotension".
no hypotension
Basal hemodynamic parameters and hemodynamic values will be taken every two minutes after induction until surgical incision. Patients with systolic pressure <90 mmHg or 30% drop in baseline, and mean artery pressure below 60 mmHg will be considered to have hypotension. Patients will be divided into two groups as "Hypotension" and "No Hypotension".

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
tricuspid anular plane systolic excursion(TAPSE)
Time Frame: TAPSE will be measured with Transthoracic Echocardiography about 30 minutes before the induction in the preoperative period.
The investigators purpose is to predict hypotensive condition that can develop after general anesthesia induction by measuring the Tricuspid Annular Plane Systolic Movement (TAPSE), which is an echocardiographic parameter.
TAPSE will be measured with Transthoracic Echocardiography about 30 minutes before the induction in the preoperative period.

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.
Bursa City Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ferdi Gülaştı, Bursa City Hospital

Publications and helpful links

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General Publications

Study record dates

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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.
September 9, 2020

Primary Completion (ANTICIPATED)

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.
September 9, 2021

Study Completion (ANTICIPATED)

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.
September 10, 2021

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 2, 2020

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 2, 2020

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 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

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.
October 20, 2020

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.
October 18, 2020

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.
October 1, 2020

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.
  • 2020-6/1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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