跳至主要内容
临床试验/NCT05703321
NCT05703321招募中不适用

The Relationship of Preoperative Fasting With Tricuspid Annular Plane Systolic Movement in Female Patients

Aydin Maternity and Child Health Hospital1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2022年11月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
21
试验地点
1
主要终点
TAPSE volume

研究概览

简要总结

Background Fasting for 6 hours is required for the patients regarding the preparation of the operation and preparation for anesthesia. It is already known that this fasting period affects volume. Although Tricuspid Annular Plane Systolic Movement (TAPSE) is an echocardiographic parameter showing Right Ventricular (RV) systolic function, its relationship with volume is discussed in recent years. In the present study, the relationship between TAPSE and volume, and whether there is a change in preoperative fasting and right ventricular functions will be evaluated.

Methods The study was started between 21.11.2022 and 21.05.2023 in Aydın Maternity and Child Hospital after approval was received from the Non-Invasive Clinical Research Ethics Committee. A total of 21 patients were planned to be included in this prospective observational study. Transthoracic echocardiography will be performed in patients aged 18-65 years who will undergo elective procedures under anesthesia, and in full patients the day before surgery. Those who are pregnant, patients with known or prospective severe valvular disease, severe pulmonary hypertension, acute myocardial infarction, dilated and hypertrophic cardiomyopathy, and non-sinus rhythm will be excluded from the study. Transthoracic echocardiography will be performed on the patients, and the relationship between TAPSE and volume and whether there is a change in preoperative fasting and right ventricular functions will be evaluated.

详细描述

It is already known that right ventricular systolic dysfunction has prognostic value in various pathological conditions. Evaluating RV function with echocardiography is difficult because of the complex geometry of the RV. Although RV function was evaluated only visually for many years, guidelines have been published by the American Society of Echocardiography as a result of studies conducted in recent years. In this respect, abnormal RV function must be suspected in case of one of the following criteria S'<10 cm/s, TAPSE <16 mm, RVFAC <35%, or R-MPI (tissue Doppler) > 0.55. Combining multiple measures of RV function can more reliably distinguish normal from abnormal function. TAPSE is a parameter that can be easily measured for apex-basal shortening and gives specific information about the global RV function. When compared to other measures of RV function, it is less dependent on optimal image quality and easier to measure. Low TAPSE is not very common but has been measured in some individuals without heart disease because of measurement errors, diagnostic misclassification, and extremes of the normal spectrum. It was shown in the study conducted by Gullupınar et al. that TAPSE decreased significantly after blood donation in people who had donated blood. Also, studies are trying to determine a relationship between central venous pressure, which is a volume indicator, and TAPSE. There is also a study that reported a relationship between cardiac MRI and CT and the right ventricle.

The purpose of the present study is to try to correlate the volume change of TAPSE because of preoperative hunger and to determine whether there is a change in preoperative fasting and right ventricular functions.

Purpose: To show whether there is a relationship between volume and TAPSE. To determine the relationship of TAPSE with preload and its usability for this purpose, and whether there is a change in preoperative fasting and right ventricular functions.

Hypothesis: TAPSE value is related to volume.

Material Method The study will start between 21.11.2022 and 21.05.2023 in Aydın Maternity and Child Hospital, after the approval of the Non-Invasive Clinical Research Ethics Committee. Measurements will be made and recorded with Transthoracic Echocardiography (TTE) one day before the surgery, and TTE again if the preoperative fasting times on the day of the operation are appropriate in patients aged between 18-65 years who will undergo elective procedures under anesthesia. TTE will be made by the principal investigator Ferdi GULASTI. The demographic characteristics of the patients, preoperative blood values, heart rate during TTE, oxygen saturation (SaO2), Systolic Arterial Pressure (SAP), Diastolic Arterial Pressure (DAP), and Mean Arterial Pressure (MAP) will be recorded. The data will be compared statistically after the data collection process for the study is completed.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Being between the ages of 18-65
  • Having no peroperative hydration
  • Preoperative sedative not given
  • No known heart disease

排除标准

  • Being pregnant
  • Post cardiac surgery
  • Severe pulmonary hypertension
  • Severe valve disease
  • Hypertrophic or dilated cardiomyopathy
  • Presence of acute myocardial infarction
  • Non-sinus rhythm

结局指标

主要结局

TAPSE volume

时间窗: 6 month

TAPSE, which is the right ventricular systolic function value, decreases after fasting, which is desired before the surgery

次要结局

  • fasting RV function(6 month)

研究者

发起方
Aydin Maternity and Child Health Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

ferdi gülaştı

Anesthesiologist

Aydin Maternity and Child Health Hospital

研究点 (1)

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