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临床试验/NCT03408938
NCT03408938已完成不适用

The Value of Continuous Noninvasive Hemoglobin Monitoring Using Masimo Radical Pulse Co-oximeter in Intraoperative Blood Transfusion Practice During Obestatric Procedure

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年4月11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
1
主要终点
Transfusion improvement

研究概览

简要总结

The principle aim of this study is to detect the accurracy of Masimo Radical-7¿ Pulse CO-Oximeter in relation to laboratory hemoglobin and estimated blood loss in intraoperative blood transfusion practice during obstetric procedures with high risk of bleeding.

详细描述

Photoplethysmography of peripheral perfusion can be displayed by pulse oximeters. While the pulse oximeterplethysmogram represents a volume change and the arterial line blood pressure tracing represents a pressure change, it has been demonstrated that cyclical shifts in the plethysmogram reflect similar cyclic changes in the blood pressure tracing and that these changes reflect changes in the intravascular volume status of patients.Plethysmography Variability Index (PVI) is a measure of the dynamic changes in the perfusion index (PI) that occur during the respiratory cycle . PVI = ﴾PI Max - PI Min﴿ ÷ PI Maxx 100 %.

PVI has the potential to provide useful information concerning changes in the balance between intrathoracic airway pressure and intravascular fluid volume. Trending of PVI may be useful in monitoring surgical patients, both intraoperatively and postoperatively, for appropriate hydration states. For example, a rising PVI may indicate developing hypovolemia and gives an alarm for the need of appropriate fluid and or blood products transfusion supported by the patient hemoglobin level.

Continuous Hb monitoring may allow a more rapid detection of clinically significant blood loss, and has the potential to significantly improve perioperative transfusion practices, may enable a more rapid assessment of a patient's condition and more appropriate blood management and even perhaps reduce needless transfusions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
16 Years 至 44 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • All adult high risk patients (ASA 1-2)
  • Age group (16-44 years old)
  • Obtetric surgery with high risk of bleeding in early and late pregnancy e.g Disturbed ectopic pregnancy ,Vesicular mole , Abortion , Placenta accrete , Rupture uterus and placenta previa

排除标准

  • Significant liver disease defined as (serum alanine aminotransferase and serum aspartate aminotransferase >2.5 times normal).
  • Significant renal disease defined as (serum creatinine >1.5 mg/dl or creatinine clearance <40 ml/min).
  • Significant coagulopathy defined as (INR >1.5).
  • Use of antiplatlets or anticoagulants.
  • Anemic patients with Hb% less than 8 gm/dl

结局指标

主要结局

Transfusion improvement

时间窗: 24 hours

Improvement of transfusion practice by detecting the amount of transfused units of RBCs during rapid blood loss

次要结局

  • Agreement between SpHb and laboratory Hb values(24 hours)

研究者

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

Ahmed Abdalla

Assistant Professor of Anesthesia&I.C.U and Pain Clinic

Cairo University

研究点 (1)

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