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临床试验/NCT03757442
NCT03757442已完成不适用

An Observational Study of the Association Between the Perioperatively Measured Peripheral Perfusion Index, Postoperative Complications and Mortality in Acute Surgical Patients

Hvidovre University Hospital1 个研究点 分布在 1 个国家目标入组 1,338 人开始时间: 2019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
1,338
试验地点
1
主要终点
Any severe complication or death

研究概览

简要总结

Introduction Perioperative haemodynamic instability is associated with postoperative morbidity and mortality. Macrocirculatory parameters, such as the conventionally obtained mean arterial blood pressure and cardiac output, may be uncoupled from the microcirculation during sepsis and severe blood loss and may not necessarily be optimal resuscitation parameters. The peripheral perfusion index (PPI) is derived from the pulse oximetry signal and reflects perfusion. Reduced peripheral perfusion is associated with morbidity in critically ill patients and in patients following acute surgery. We hypothesize that patients with low intraoperative PPI demonstrate high frequency of postoperative complications and mortality regardless of blood pressure.

Methods and analysis We plan to conduct a prospective observational cohort study in patients undergoing acute non-cardiac surgery (November 1st, 2017 to October 31st, 2018) at two University Hospitals. Data will be collected prospectively from patient records including patient demographics, comorbidity and intraoperative hemodynamic values, with PPI as the primary exposure variable, and postoperative complications and mortality within 30 and 90 days as outcome variables. We primarily assess association between PPI and outcome in multivariate regression models. Secondly, the predictive value of PPI for outcome, using area under the receiver operating characteristics curve is assessed.

Ethics and dissemination Data will be reported according to The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). Results will be published in a peer reviewed journal. The study is approved by the regional research ethics committee, storage and management of data has been approved by the Regional Data Protection Agency, and access to medical records is approved by the hospital board of directors at the involved hospitals and departments.

详细描述

Background Perioperative haemodynamic instability is associated with postoperative morbidity and mortality. Patients undergoing acute major abdominal or hip fracture surgery have high complication rates and account for a major part of overall postoperative mortality in developed countries. These patients are often frail, with multiple comorbidities making them vulnerable to anaesthesia and surgery. Despite the benefit of a multidisciplinary effort to improve perioperative care, such patients demonstrate a high risk of complications and death. Conventional perioperative haemodynamic monitoring is often based only on heart rate (HR) and mean blood pressure (MAP). Although perioperative hypotension is associated with complications in major surgery, blood pressure is often an inadequate marker of perioperative organ perfusion, consequently leading to little precision in administration of fluid and vasoactive medication. Minimally-invasive haemodynamic monitoring of cardiac output (CO), and goal directed therapy based on stroke volume optimization, has been associated with improved outcome in major elective surgery, but high quality evidence for the advantage of such monitoring in emergency surgery is sparse.

Macrocirculatory parameters such as MAP and CO may be uncoupled from the microcirculation during sepsis and severe blood loss due to sympathetic or medically induced vasoconstriction, and as such, these parameters are not necessarily optimal for resuscitation.

Assuming that blood flow is directed from peripheral tissue to vital organs during progressive stages of circulatory impairment and shock, a non-invasive method to detect impaired peripheral perfusion could be a relevant endpoint.

The peripheral perfusion index (PPI) has the advantage that is derived from the photoelectric plethysmographic pulse oximetry signal most likely obtained in all patients for evaluation of arterial oxygen saturation (SAT) already in the emergency room and continued during and after surgery as in wards and in the ICU. The PPI reflects the ratio between the pulsatile and non-pulsatile component of the arterial waveform as assessed by light traversing the tissue addressed, most often the finger, and it decreases in response to hypoperfusion.Thus, PPI reflects changes in peripheral perfusion and blood volume and reduced peripheral perfusion is associated with morbidity following acute surgery, in critically ill patients, and patients presenting septic shock. However, it remains uncertain which threshold for PPI should trigger intervention in patients undergoing acute surgery reflecting that evaluation is made only in relatively small populations of mixed medical and surgical patients.

Hypothesis We hypothesize that PPI reflects impaired peripheral circulation and that patients with low intraoperative PPI, independent of MAP, have higher risk of postoperative complications and mortality than patients with normal or high PPI.

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 for or having performed procedures with the following procedural codes: KNFB02, KNFJ81, KNFJ51, KNFJ52, KNFJ70 representing arthroplasty, intra-medullar nailing, and screws respectively.
  • For abdominal surgery patients we include patients booked for acute laparoscopy for diagnostic purposes (KJAH01) and explorative laparotomy (KJAH00). To identify all patients having performed acute abdominal surgery, we also include surgery related to ileus: KJFK00, KJFK01, KJFK10, KJAP00, KJAP01, KJFK96, KJFK97, any perforation of vicera: KJDA60, KJDA70, KJDA80, and any ischemic condition of the gut: KJFB00, KJFB01, KJFB33, KJFB34, KJFB96, KJFB97.

排除标准

  • No sampling of PPI registered
  • Foreign/temporary civil registration number that prevents follow up
  • Earlier enrollment in cohort

结局指标

主要结局

Any severe complication or death

时间窗: 30 days

Severe postoperative complications (Clavien Dindo III-IV) or death (Clavien Dindo V)

次要结局

  • Any severe complication or death(90 days)

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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