跳至主要内容
临床试验/NCT02668250
NCT02668250已完成不适用

The OPTI-AGED Study : Influence of a Multi-parametric Optimization Strategy for General Anesthesia on Postoperative Morbidity and Mortality in Elderly Patients. A Randomized, Multicentre, Prospective Controlled Study

Centre Hospitalier Universitaire de Saint Etienne29 个研究点 分布在 1 个国家目标入组 2,495 人开始时间: 2017年2月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
2,495
试验地点
29
主要终点
Incidence of a composite of mortality or major postoperative morbidity.

研究概览

简要总结

With the increasing aging population demographics and life expectancies, the number of very elderly patients undergoing surgery is rising. Elderly patients constitute an increasingly large proportion of the high-risk surgical group.

Cardiac complications and postoperative pulmonary complications are equally prevalent and contribute similarly to morbidity, mortality, and length of hospital stay. Specific optimization strategy of general anesthesia has been tested in high-risk patients undergoing major surgery to improve outcomes.

Our hypothesis is that a combined optimization strategy of anesthesia concerning hemodynamic, ventilation, and depth of anesthesia may improve short- and long- term outcome in elderly undergoing high risk surgery.

详细描述

The population is expanding and aging. With the increasing aging population demographics and life expectancies, the number of very elderly patients (age ≥ 75) undergoing surgery is rising. Elderly patients constitute an increasingly large proportion of the high-risk surgical group. In 2010, patients aged 75 yrs and over represented only 2.1% of patients undergoing high risk surgery in France (PMSI database), but concentrated 27% of in-hospital deaths.

Cardiac complications and postoperative pulmonary complications are equally prevalent and contribute similarly to morbidity, mortality, and length of hospital stay. Specific optimization strategy of general anesthesia has been tested in high-risk patients undergoing major surgery to improve outcomes. Meta-analyses have demonstrated that goal directed hemodynamic therapy significantly reduced mortality and surgical complications in high-risk patients. A lung-protective ventilation strategy in high-risk patients undergoing major abdominal surgery was associated with improved clinical outcome. Retrospective studies indicated that a combination of excessive depth of anesthesia, hypotension and low anesthesia requirement resulted in increased mortality. These approaches of peroperative care remain discussed in the literature and have also to be incorporated in the common clinical practice. Moreover, few of these reviews performed a sensitive analysis in the elderly.

Whether a multi-parametric optimization strategy of anesthesia including several specific interventions will impact the short-term postoperative major morbidity and mortality in elderly is not known. The addition of depth of anesthesia monitoring to hemodynamic monitoring and goal directed hemodynamic therapy may improve tissue perfusion by reducing hemodynamic side effects of anesthetic agents, particularly in elderly where the therapeutic window of these agents is reduced. The effects of low protective ventilation may also by additive to the previous measures by reducing the perioperative build-up of oxygen debt. Our hypothesis is that a combined optimization strategy of anesthesia concerning hemodynamic, ventilation, and depth of anesthesia may improve short- and long- term outcome in elderly undergoing high risk surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • •All adult patients aged 75 years and over,
  • •presenting at least one of the following comorbidities: ischemic coronary disease; cardiac arrhythmia; congestive heart failure; peripheral vascular disease; dementia; stroke; chronic obstructive pulmonary disease; chronic respiratory failure; chronic alcohol abuse; active cancer; diabetes; chronic renal failure A comorbidity index will be measured by using the modified Charlson Comorbidity Index
  • •undergoing elective and emergency surgeries including : femoral head fracture, major intraperitoneal abdominal surgery lasting > 90 min (excluding elective cholecystectomy, abdominal wall surgery), vascular surgery (excluding venous surgery and fistula creation)
  • •Patient's or patient's relative signed consent form
  • •Affiliation to French social assurance system

排除标准

  • •Acute heart failure and acute coronary syndrome
  • •Acute respiratory failure, pneumonia
  • •Septic shock
  • •Acute stroke
  • •Evolutive neuromuscular disorder
  • •Thoracic surgery, combined abdominal and thoracic surgery
  • •Surgery performed under exclusive regional anesthesia
  • •Patients under tutorship or curatorship
  • •Refusal to participate

研究组 & 干预措施

Experimental group : OPTI-AGED

Experimental

The OPTI-AGED group will receive a combined optimization strategy of anesthesia concerning hemodynamic, ventilation, and depth of anesthesia.

干预措施: OPTI-AGED (Procedure)

Control Group :

Active Comparator

The control group will not benefit from the OPTI-AGED intervention but patients will receive the usual care.

干预措施: Usual Care (Procedure)

结局指标

主要结局

Incidence of a composite of mortality or major postoperative morbidity.

时间窗: Day 30

One or more of major postoperative complications : acute kidney injury (defined by Kidney disease : improving Global Outcomes (KDIGO) stage 1 or higher), acute myocardial infarction, heart failure, stroke, development of sepsisand septic shock, acute respiratory failure requiring non-invasive ventilation or intubation, delirium) will be reported in the source folder of the patients, and the mortality will be also focused. The goal of this study is to decrease this incidence.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (29)

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