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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04580030
Other study ID # 2020-6/1
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 9, 2020
Est. completion date September 10, 2021

Study information

Verified date October 2020
Source Bursa City Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 7
Est. completion date September 10, 2021
Est. primary completion date September 9, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Bursa City Hospital Bursa

Sponsors (1)

Lead Sponsor Collaborator
Bursa City Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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: 10.11 — View Citation

Szabó M, Bozó A, Darvas K, Horváth A, Iványi 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/s12871-019-08 — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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