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

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: Unknown
• Conditions: Anesthesia

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: Observational
• Enrollment (Anticipated): 7

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey
    • Bursa City Hospital

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

Outcome Measure	Measure Description	Time Frame
tricuspid anular plane systolic excursion(TAPSE)	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

• Sponsor: Bursa City Hospital
• Investigators: Study Chair: Ferdi Gülaştı, Bursa City Hospital

Publications and helpful links

General Publications

• Zhang J, Critchley LA. Inferior Vena Cava Ultrasonography before General Anesthesia Can Predict Hypotension after Induction. Anesthesiology. 2016 Mar;124(3):580-9. doi: 10.1097/ALN.0000000000001002.
• Szabo M, Bozo A, Darvas K, Horvath A, Ivanyi ZD. Role of inferior vena cava collapsibility index in the prediction of hypotension associated with general anesthesia: an observational study. BMC Anesthesiol. 2019 Aug 7;19(1):139. doi: 10.1186/s12871-019-0809-4.
• Main AB, Braham R, Campbell D, Inglis AJ, McLean A, Orde S. Subcostal TAPSE: a retrospective analysis of a novel right ventricle function assessment method from the subcostal position in patients with sepsis. Ultrasound J. 2019 Aug 27;11(1):19. doi: 10.1186/s13089-019-0134-7.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 9, 2020
• Primary Completion (ANTICIPATED): September 9, 2021
• Study Completion (ANTICIPATED): September 10, 2021

Study Registration Dates

• First Submitted: October 2, 2020
• First Submitted That Met QC Criteria: October 2, 2020
• First Posted (ACTUAL): October 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 20, 2020
• Last Update Submitted That Met QC Criteria: October 18, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: hypotension; General anesthesia; tricuspid anular plane systolic excursion
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID 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