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临床试验/NCT05874687
NCT05874687Enrolling By Invitation不适用

Tricuspid Annular Plane Systolic Excursion to Predict Arterial Hypotension Caused by Spinal Anesthesia in Caesarean Section

Aydin Maternity and Child Health Hospital1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2023年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
3
试验地点
1
主要终点
ceserenan tapse

研究概览

简要总结

This cross-sectional blinded study was planned to be conducted in Aydın Gynecology and Pediatrics Hospital between June 2023 and September 2023. The study was designed for adult pregnant female cases between the ages of 20 and 35. Patients with Class II American Society of Anesthesiologists (ASA) physical status, scheduled for elective cesarean section under subarachnoid block and who gave informed consent were planned to be included in the study.

Patients with emergencies and uncontrolled systemic comorbidities (e.g., cardiovascular, respiratory or renal) and patients with expected massive intraoperative loss (i.e., placenta accreta or placenta previa) are planned to be excluded from the study. Also, cases receiving intravenous fluid preload will be excluded.

详细描述

This cross-sectional blinded study was planned to be conducted in Aydın Gynecology and Pediatrics Hospital between June 2023 and September 2023. The study was designed for adult pregnant female cases between the ages of 20 and 35. Patients with Class II American Society of Anesthesiologists (ASA) physical status, scheduled for elective cesarean section under subarachnoid block and who gave informed consent were planned to be included in the study.

Patients with emergencies and uncontrolled systemic comorbidities (e.g., cardiovascular, respiratory or renal) and patients with expected massive intraoperative loss (i.e., placenta accreta or placenta previa) are planned to be excluded from the study. Also, cases receiving intravenous fluid preload will be excluded.

Echocardiography The same observer will perform TTE on all patients in the left lateral decubitus position with an echocardiography device. The values of all parameters will be determined by taking the average values of three cardiac cycle measurements. Measurement methods will be used in accordance with the guidelines of the American Society of Echocardiography. M-Mode, 2D (2D) images, color, pulse and continuous wave Doppler and tissue Doppler measurements will be taken from all subjects who are suitable for standard Echocardiography. LV Ejection Fraction (EF) measurements will be evaluated in the parasternal long axis view.

FAC and TAPSE will be used to evaluate Right Ventricular (RV) systolic functions. Tricuspid E and A Wave Velocity and E/A Ratio will be measured to evaluate the diastolic function of the RV. TAPSE, echocardiography device and TTE will be used for all patients by the same observer. Echocardiography will be performed in the left lateral supine position. TAPSE will be calculated in an apical 4-chamber view by placing an M-mode cursor across the Tricuspid Ring and measuring the amount of longitudinal movement at peak systole and the values will be recorded by averaging the five cardiac cycle measurements.

Patients will be visualized in the supine position through the subxiphoid window of the Inferior Vena Cava (IVC). The cursor will be placed 1 cm distal to the hepatic vein IVC entry point and the IVC diameter will be monitored for 30 seconds in M-Mode. And the measurement will be made from the region where the diameter of the inferior vena cava is in inspiration (IVCins) and expiration (IVCexp) while the patient is breathing normally. The Inferior Vena Cava Collapse Index (IVC-CI) will be calculated by using the formula IVC-CI = (IVCexp - IVCins) / IVCexp.

研究设计

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

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 37-42 gestational-week single pregnancies
  • Being between the ages of 20-35
  • BMI between 20-35

排除标准

  • Non-sinus rhythm
  • ASA III and above
  • Known heart disease
  • Multiple pregnancy
  • Expected massive intraoperative loss (i.e., placenta accreta or placenta previa)
  • Severe pulmonary hypertension, wall motion disorder, severe valve disease, hypertrophic or dilated cardiomyopathy in echocardiography
  • A TAPSE value of 1.7 cm or less

研究组 & 干预措施

1: hypotension +,

hypotension +: hypotension defined as a decreased SAB greater than 20% of baseline, a decreased MAP below 90 mmHg, or a MAP of 65 mmHg

干预措施: hypotension + treat (Drug)

结局指标

主要结局

ceserenan tapse

时间窗: 3 months

The primary outcome measure was the development of hypotension after spinal anesthesia.

次要结局

未报告次要终点

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

MEDİCİNE DOCTOR

Aydin Maternity and Child Health Hospital

研究点 (1)

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