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临床试验/NCT04738006
NCT04738006已完成不适用

Establishing Routine Preoperative Gastric Ultrasound for Patients With an Increased Aspiration Risk in a Swiss Teaching Hospital: A Prospective Observational Study.

Kantonsspital Winterthur KSW1 个研究点 分布在 1 个国家目标入组 2,003 人开始时间: 2021年1月18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
2,003
试验地点
1
主要终点
Training Validation

研究概览

简要总结

Preoperative gastric sonography may provide a validated, reliable, fast, and cost-efficient approach to assess aspiration risks in both elective and emergency patients. Practiced sonographers are able to perform point-of-care gastric sonography in a few minutes, thus severe delay in daily clinical practice should not be expected. Nevertheless, how this highly sensitive and specific tool should be best established in daily clinical practice is still unclear. There are no preexisting structured and validated trainings for this specific point-of-care ultrasound application. To address these issues, all patients with increased aspiration risk at the Institute of Anaesthesiology in Winterthur will be evaluated for participation during a one year recruiting period. Participants will receive a preoperative gastric ultrasound by a trained professional.

The aim of this investigation is to validate our structural training and proof the importance and effectiveness of this diagnostic tool to lay ground for improvement of anesthesiologic management and presumably patient safety in patients with an increased risk of a pulmonary aspiration.

详细描述

Aspiration pneumonias still exhibit a significant morbidity and mortality and are accountable for a significant part of anaesthesia-related deaths. Various diseases and especially emergency situations correlate with prolonged gastric emptying and therefore with a higher risk of pulmonary aspiration. In clinical practice the decision to perform a Rapid Sequence Induction (RSI) is mostly based on clinical and anamnestic findings. Preoperative gastric sonography may provide an objective, validated, non-invasive, reliable, fast, and cost-efficient approach to assess aspiration risks in both elective and emergency patients.

How this highly sensitive and specific tool may be best introduced and implemented in daily clinical practice or anesthesiologic guidelines remains unclear. Structured educational programmes or training recommendations for this point-of-care ultrasound application rarely exist.

Objectives:

  1. Establish preoperative gastric sonography before Rapid Sequence Induction (RSI) and in patients with one or more aspiration risk factors scheduled for a advanced laryngeal mask (LMa) or regional anaesthesia at the Kantonsspital Winterthur, Department of Anaesthesiology.
  2. Validation of our structured training/education by comparing sonographic estimated and directly measured gastric content.
  3. Emphasize the importance and effectiveness of this diagnostic tool to improve anesthesiologic management.

At the Cantonal Hospital of Winterthur, a mid-size Swiss teaching hospital all residents and attending anaesthesiologists will receive a structured training in a period of 1 to 8 weeks before inclusion of the first patient. All participating staff will give written informed consent to participate in the study.

研究设计

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

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

  • All elective in-hospital Rapid Sequence Inductions (RSI) and patients with one or more aspiration risk factors scheduled for a advanced laryngeal mask or regional anaesthesia with informed consent.
  • All emergency in-hospital RSIs and patients with one or more aspiration risk factors scheduled for an advanced laryngeal mask or regional anaesthesia with informed consent graded "Notfall 1-6h, nicht vital (dringlicher Eingriff)" or, "Notfall 6-24h nicht vital (aufgeschobener dringlicher Eingriff)" according to the Swiss Society for Anaesthesiology and Resuscitation (A-QUA).

排除标准

  • Life threatening/ time critical emergency interventions, graded followingly according to the Swiss Society for Anaesthesiology and Resuscitation (A-QUA): Notfall <1h, vital (sofortiger Eingriff notwendig)
  • Known pregnancy
  • Obstetric surgery
  • Underage (< 18 years)
  • Absence of informed consent (missing or inability to provide)
  • No anaesthetist with completed structural education is available.
  • Contraindications for naso- or orogastric tubes or inability to correctly place such.

结局指标

主要结局

Training Validation

时间窗: 1 year

Correlation of sonographic estimated gastric volume (CSA to ml) with volume aspirated (ml) through a naso- or oro-gastric tube, that was placed by routine due to the RSI or LMa procedure itself.

次要结局

  • Training Performance 3: Confounders(1 year)
  • Anesthesiologic Management 1: descriptive(1 year)
  • Training Performance 2: over time(1 year)
  • Training Performance 1: Descriptive over all sonographies performed(1 year)
  • Anesthesiologic Management 2: Correlation(1 year)
  • Patient population and fasting/gastric volume(1 year)

研究者

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

Roman Meierhans

Principal Investigator

Kantonsspital Winterthur KSW

研究点 (1)

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