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临床试验/NCT02722226
NCT02722226已完成不适用

The Impact of a High Fidelity Simulation Based Sedation Training on the Performance of Non-anesthesiologists Residents for the Management of Complications Associated to Sedation.

Issam Tanoubi0 个研究点目标入组 32 人开始时间: 2012年3月1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
发起方
入组人数
32
主要终点
Improved residents performance after simulation based education, measured by previously built performance grid

研究概览

简要总结

Objective Sedation is a depression of consciousness varies between anxiolysis and general anesthesia. It is used to facilitate diagnostic tests and minor surgeries. Respiratory complication is the main side effect of the sedation. His Early diagnosis and adequate management prevent serious complications such as hypoxic brain damage or death. A development of a learning program of sedation is required. Simulation as a teaching tool has improved the clinical expertise of learners. The objective of the study is to evaluate the impact of a simulation based medical education program on the performance of non-resident anesthesiologists for the management of complications related to sedation.

Methods This trial is randomized, controlled and single blinded. Non-resident anesthesiologists, without prior training on sedation, are included and randomized to receive or not a simulation based sedation learning. This program includes a pharmacology sedatives learning, teaching technical skills for airway management on low fidelity mannequin and high-fidelity simulation scenarios of these complications. Two evaluators, single-blinded, visualise the recorded performance of residents in simulation session. The evaluation is based on a performance checklist developed by Delphi technique. It compares the performance of the residents within the same group before and after the simulation based medical education program and to compare groups of residents.

Data analysis The sample size is based on similar simulation studies. The results are compared with the variance analysis for repeated measures. The difference in performance before and after simulation is compared using a t test.

The investigators hypotheses that improved performance scores following the simulation based medical education would put the dot on the importance of simulation as a learning tool.

详细描述

Sedation is a drug depression of consciousness and alertness. It involves intravenous hypnotics and narcotics administration. Depending on doses and blood levels of administered agents, there is a continuum between anxiolysis, light sedation (monitored anesthesia care), deep sedation and general anesthesia.

Sedation is used to facilitate diagnostic examinations, minor surgery, endoscopic surgery and endovascular or transcutaneous therapeutic radiological procedures. It provides comfort to the patient during the procedure and better conditions for examination or treatment for the operator.

The main risk during procedural sedation is compromising the patient's respiratory function and airway. The obstruction of the upper airway by the tongue, soft palate or epiglottis on one hand and respiratory depression due to the sedative on the other hand are the major problems of sedation. In addition to respiratory depression, decreased airway protective reflexes during sedation exposes to the gastric contents aspiration and consequent respiratory complications.

Major complications are rare: one case of death of 160,000, 1 case of tracheal intubation of 58 000 and no cases of permanent neurologic damage of 646,000 gastrointestinal endoscopies performed under sedation. More common, the incidence of partial obstructions requiring airway maneuvers release (mandibular subluxation, oropharyngeal airway device, nasopharyngeal airway device) is 14.4%, 12.8% of hypoxemia, 0.1% of ventilation with face mask and in 0.6% the ongoing procedure needed to be stopped.

Although these incidents are without clinical severity, they can cause serious complications if diagnosed late or in inadequate care. Various analyzes of the American Society of Anesthesiology claims related to sedation, prove the seriousness of these complications and the importance of their early management, 40% of claims involving death or hypoxic permanent brain injury could be prevented and 50% of claims are related to anesthetic procedures performed outside the operating room. Respiratory depression associated with an absolute or relative overdose of sedative is the primary mechanism of complications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Residents from surgery programs, radiology, gastroenterology, pneumology, family medicine, emergency medicine of the University of Montreal
  • •Residents with academic supervision with 1: 1 by a senior during their clinical practice

排除标准

  • •Resident with prior instruction on sedation or advanced learning technical skills for airway management.
  • •Refusal to participate

研究组 & 干预措施

Simulation based sedation learning (Intervention Group)

Experimental

The program includes online learning. It is followed by development of interactive presentations, based on simulated cases or simulated patients (actors), low fidelity simulation for specific technical skills as well as high fidelity scenarios of complications related to sedation.

干预措施: Simulation (Other)

Simulation based sedation learning (Intervention Group)

Experimental

The program includes online learning. It is followed by development of interactive presentations, based on simulated cases or simulated patients (actors), low fidelity simulation for specific technical skills as well as high fidelity scenarios of complications related to sedation.

干预措施: Airway management (Device)

Simulation based sedation learning (Intervention Group)

Experimental

The program includes online learning. It is followed by development of interactive presentations, based on simulated cases or simulated patients (actors), low fidelity simulation for specific technical skills as well as high fidelity scenarios of complications related to sedation.

干预措施: Crisis resource management (Behavioral)

Control Group

No Intervention

结局指标

主要结局

Improved residents performance after simulation based education, measured by previously built performance grid

时间窗: 3 to 6 months

次要结局

未报告次要终点

研究者

发起方
Issam Tanoubi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Issam Tanoubi

MD, Assistant Professor

Université de Montréal

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