跳至主要内容
临床试验/NCT04822116
NCT04822116已完成不适用

Continuation of Goal Directed Haemodynamic Optimization in the Postanaesthesia Care Unit on the Basis of Non-invasive Methods: a Randomized Controlled Trial.

University Hospital Schleswig-Holstein2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年4月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
pulmonary oedema

研究概览

简要总结

Post-operative monitoring of all patients after anaesthesia in the post anaesthesia care unit (PACU) is standard of care today. It helps to reduce morbidity and even mortality in high-risk patients.

In addition to clinical monitoring by qualified staff, standard monitoring in the PACU includes non-invasive, intermittent, haemodynamic monitoring.

This research is going to investigate the influence of the continuation of goal directed haemodynamic optimization in the recovery room on the basis of non-invasive monitoring tools, i.e. ultrasound and the volume-clamp method, in regard of length of stay in the PACU and postoperative complications.

详细描述

Postoperative monitoring of all patients after surgery in post anaesthesia care unit (PACU) is standard of care today. It helps to reduce morbidity and even mortality in high-risk patients.

In addition to clinical monitoring by qualified staff, standard monitoring in the PACU includes non-invasive, intermittent, haemodynamic monitoring. The time of transfer of patients from the PACU to the general ward is assessed on the basis of several parameters. There is consensus on the most important endpoints of transferability: awareness, quality of spontaneous breathing, circulatory situation, bleeding situation, body temperature, diuresis and satisfactory freedom from pain and absence of nausea, but the processes and contents and how they can be established as quickly and sustainable as possible are not yet defined.

This research will investigate the influence of continuing non-invasive, goal-directed haemodynamic optimization in the recovery room, after major traumatological, general and vascular surgery.

In a randomized controlled trial the investigators will include a population of 80 patients with a minimum age of 18 years in the study after clarification and approval.

The control group will be routinely treated with an appropriate protocol for goal-oriented haemodynamic optimization. The study group will receive targeted haemodynamic optimization using Vigileo FlowTrac-Analysis and transthoracic echocardiography in the operation room and finger-cuff based pulse analysis technology in the PACU. The observed parameters of targeted haemodynamic optimization will be stroke volume and cardiac output, volume response parameters and collapsability of the inferior vena cava for the volume status.

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
Single (Investigator)

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

  • patients with ASA classification I-III undergoing abdominal surgery, surgery in urology or vascular surgery
  • written consent

排除标准

  • Age <18 years
  • ASA classification IV or higher
  • legal care relationship
  • missing or faulty written consent

结局指标

主要结局

pulmonary oedema

时间窗: through study completion, an average of 1 year

Number of post-operative complications

acute kidney failure

时间窗: through study completion, an average of 1 year

Number of post-operative complications

wound infection

时间窗: through study completion, an average of 1 year

Number of post-operative complications

pneumonia

时间窗: through study completion, an average of 1 year

Number of post-operative complications

次要结局

  • 28-day survival(through study completion, an average of 1 year)
  • length of stay in the PACU(through study completion, an average of 1 year)
  • length of stay in hospital(through study completion, an average of 1 year)

研究者

发起方
University Hospital Schleswig-Holstein
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Jochen Renner

Clinical Professor

University Hospital Schleswig-Holstein

研究点 (2)

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