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临床试验/NCT03795467
NCT03795467Unknown不适用

Association Between the Peripheral Perfusion Index, Haemoglobin Levels and Blood Transfusions in Patients Undergoing Acute Abdominal- and Orthopaedic Surgery.

Hvidovre University Hospital1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,500
试验地点
1
主要终点
Peripheral perfusion index

研究概览

简要总结

The peripheral perfusion index (PPI) is a non-invasive, feasible measure of peripheral perfusion and, assumed, the overall circulation, which all patients are monitored by.

This study is carried out to assess the association between values of PPI, haemoglobin and blood transfusion.

Hypothetically, patients with low values of hb are more susceptible to a deteriorating circulation reflected in poorer PPI regardless of blood pressure and that resuscitation with blood products improves PPI measurements. Moreover, that patients with low values of PPI have more surgical complications and higher mortality.

详细描述

Background: Acute surgical patients with e.g. hip fracture (HF) or acute abdominal surgical conditions often have comorbidities and a fragile circulation. Haemodynamic challenges make these patients vulnerable during anaesthesia, and perioperative complications are frequent.

Anaemia is associated with increased mortality and adverse outcomes in patients undergoing surgery. One of the consequences of acute anaemia is reduced blood oxygen content, leading to reduced tissue oxygen delivery and development of tissue hypoxia. Patients with e.g. HF have a large drop in haemoglobin (hb) level that occurs after the injury, yet prior to the surgery. It is therefore important to be aware of the risk of preoperative anaemia even when the initial hb levels appear to be normal. Perioperative hb are associated with shorter lengths of hospital stay, reduced mortality and lower readmission rates, and patients with postoperative anaemia have increased mortality and length of hospital stay.

Haemodynamic monitoring is traditionally based on measurement of blood pressure (BP) and heart rate (HR) but these measurements may be insufficient in evaluating overall oxygen delivery and perfusion of vital organs. An apparently sufficient BP and, for patients with more specialised monitoring, cardiac output (CO), does not necessarily mean a sufficient peripheral microcirculatory flow due to compensatory mechanisms, but on the other hand a low CO may be sufficient in context of low metabolic demand.

The non-invasive peripheral perfusion index (PPI) is a numerical value of peripheral perfusion measured by the pulse oximeter derived from the photoelectric plethysmographic signal. PPI is represents the ratio between the pulsatile component (arterial) and the non-pulsatile component (venous blood, capillary blood and other tissues) of the light reaching the detector of the pulse oximeter, and reflects changes in peripheral blood flow as the pulsatile component increases with vasodilatation and decreases with vasoconstriction. It is an accessible way to obtain a measure for peripheral perfusion as pulse oximeters are universally available in all operating rooms and intensive care units. Previous studies have shown that PPI is a useful indicator of reduced peripheral blood flow both in clinical and experimental settings. Correlation between clinical symptoms of reduced peripheral perfusion such as low temperature, increased capillary response and reduced PPI in critically ill patients has been demonstrated, and a reduced peripheral perfusion may be a predictor of mortality and complications in patients undergoing major surgical procedures and in septic shock patients.

Hypothetically, patients with low values of hb are more susceptible to a deteriorating circulation reflected in poorer PPI regardless of blood pressure and that resuscitation with blood products improves PPI measurements. Moreover, that patients with low values of PPI have more surgical complications and higher mortality.

研究设计

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

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

  • Orthopedic surgery patients with fracture of the hip, booked in the electronic patient record for operation with procedural codes:KNFB02 HNFJ81 KNFJ51 KNFJ52 KNFJ70
  • Acute abdominal surgery patients booked in the electronic patient record for operation with procedural codes:KJAH01 KJAH00

排除标准

  • No sampling of PPI registered
  • Foreign/temporary civil registration number
  • Already included in cohort

结局指标

主要结局

Peripheral perfusion index

时间窗: Perioperative with 5 minute interval

Absolute PPI levels

Haemoglobin level

时间窗: Time interval: From 3 hours preoperative to 10 hours postoperative

Measurement of haemoglobin by blood sample or artery gas.

次要结局

  • Proportion of transfusion with blood products in patients with perioperative high vs. low haemoglobin levels.(Perioperative)
  • Evaluation of Peripheral perfusion index in patients with high vs. low haemoglobin levels in relation to mean arterial blood pressure (MAP).(Perioperative)
  • Evaluation of peripheral perfusion index changes in patients with perioperative high vs. low haemoglobin levels in relation to transfusion with blood products .(Perioperative)

研究者

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

Marianne Agerskov

MD, Research Fellow

Hvidovre University Hospital

研究点 (1)

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