跳至主要内容
临床试验/NCT06423833
NCT06423833已完成不适用

Trendelenburg Maneuver Versus Passive Leg Raising Test for Fluid Responsiveness in High-Risk Surgical Patients

Tanta University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
The validity of Trendelenburg maneuver

研究概览

简要总结

The aim of this study is to evaluate whether Trendelenburg maneuver can be used to predict fluid responsiveness in high-risk surgical patients in intensive care unit as compared to Passive Leg Raising test.

详细描述

Passive Leg Raising test is a well validated dynamic method to predict fluid responsiveness with many advantages as it doesn't use fluid loading, its effect is reversible, and it doesn't rely on heart-lung interaction. However, it has many limitations as (has false negative effect in patients with intra-abdominal hypertension), also, it may not be suitable in some surgical patients.

Trendelenburg maneuver (TM) is often used to treat hemodynamic unstable patients when hypovolemia is suspected, through a mechanism similar to Passive Leg Raising test Yonis, et al reports that change in cardiac output during Trendelenburg maneuver is a reliable predictor of fluid responsiveness in patients with acute respiratory distress syndrome in prone position under protective ventilation. Another study reports that change in velocity time integral during trendelenburg maneuver predicts fluid responsiveness in cardiac surgical patients in operating rooms

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

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

入选标准

  • Aged ≥ 18 years old.
  • Criteria of high-risk surgical patients:
  • Elderly ≥ 70 years old undergoing major surgery.
  • Physical status ≥ 3 or more undergoing major surgery.
  • Major intraoperative hemorrhage with Surgical Apgar Score (SAS 0-4).
  • Emergency of upper abdominal surgery.
  • Criteria of hypoperfusion ≥ 2 or more the following:
  • Mean arterial blood pressure < 65 mmHg.
  • Urine output < 0.5 ml/Kg/hr.
  • Capillary refilling time > 4 seconds.
  • Blood lactate > 2 mmol/L.
  • ScvO2 < 70%.
  • CO2 gap > 6 mmHg.
  • Provided that:SpO2 ≥ 90% and Hb ≥ 7 g/dl.

排除标准

  • Patients with body mass index > 35 kg/m
  • Pregnant female.
  • Contraindications to the Trendelenburg position or PLR test (major head trauma, intra-abdominal hypertension and gastric retention).
  • Poor echo window or unsatisfactory cardiac echogenicity (an inability to correctly align the Doppler beam to generate reliable velocity time integral measurements at the left ventricular outflow tract [LVOT]).

结局指标

主要结局

The validity of Trendelenburg maneuver

时间窗: At the end of Trendelenburg maneuver within 1 minute

Measurement of the validity of Trendelenburg maneuver to predict fluid responsiveness by measuring the percentage change in velocity time integral (VTI) by Doppler echocardiography in high risk-surgical patients.

次要结局

  • Correlation between the accuracy of the percentage change in velocity time integral (VTI) during Trendelenburg maneuver and passive leg raising test (PLR) test(At the end of Trendelenburg maneuver and passive leg raising test within 1 minute)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatma Mohamed Samy Elaiashy

Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt

Tanta University

研究点 (2)

Loading locations...

相似试验