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临床试验/NCT04846660
NCT04846660已完成不适用

Examining the Impact of Production Pressure in the Regional Anesthesia Block Room on Patient Safety, a Randomized Single Blind Study in a High Fidelity Simulation Environment

Ciusss de L'Est de l'Île de Montréal1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2021年3月20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
39
试验地点
1
主要终点
RAPS score

研究概览

简要总结

This randomized, single blinded simulation based study investigates the impact that production pressure can have on the safety of patients undergoing regional anesthesia. We created a high fidelity scenario where anesthesiologists and trainees were to perform a single shot infraclavicular ultrasound guided block. Participants were randomly assigned to the intervention or control group. Participants assigned to the intervention group were exposed to various production pressure generating interventions. The goal of this study was to look at the impact of production pressure on patient safety by scoring anesthesiologists' and trainees' performance and examining the differences between the two groups.

详细描述

Sample size:

To our knowledge, no studies were performed to evaluate the impact of production pressure on anesthesiologists nor on how to emulate production pressure in a simulated environment. Although it is known that production pressure affects negatively healthcare workers' performance, it remains difficult to predict its impact on a scoring system such as the RAPS assessment tool. Therefore, we used a convenience sample based on the number of residents and staffs anesthesiologists who agreed to participate. Using the t value and the degrees-of-freedom of the unpaired t-test, the investigators calculated the effect size (r) to characterize the magnitude of the effect and evaluate if the sample size is enough to answer the research hypothesis. An r value of around 0.2 was considered a "weak" effect, 0.5 "medium", and 0.8 "strong". We intend to recruit between 10 to 20 participants in each group.

Scenario:

Participants were asked to obtain consent and perform a single shot infraclavicular ultrasound guided block on a 50 year old woman with mild COPD. The simulation took place in situ in a regional anesthesia block room. Upon entering the room, the anesthesiology evaluation was already completed. A CAE infraclavicular block simulator was installed on a simulated patient. A simulated anesthesiology nurse was also present to assist only. All preparation steps and safety measures had to be initiated by the participant. Participants in the intervention group were exposed to 4 standardized pre-recorded audio interventions, encouraging them to proceed faster. The choice of these interventions was based on articles and surveys detailing the common sources of production pressure for the anesthesiologist.

Data collection:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

盲法说明

Participants were blindly assigned to the intervention or control group and were blind to the level of production pressure they were exposed to. They were also blinded to the purpose of the study until completion.

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •To be a certified anesthesiologist or anesthesiology resident
  • •To have performed at least 10 regional anesthesia techniques including 5 infraclavicular blocks
  • •To consent to the study

排除标准

  • •- To refuse to participate

研究组 & 干预措施

Regular environment

No Intervention

The control group was asked to complete the same task also with unlimited time. They were not exposed to the audio recordings.

Production pressured environment

Experimental

Participants in this group were exposed to 4 audio recordings applying standardized pressure. Unlimited time.

干预措施: Production pressure (Other)

结局指标

主要结局

RAPS score

时间窗: Through scenario completion (approximatively 25 minutes)

Score obtained from regional anesthesia experts using the RAPS assessment tool, a validated tool to measure performance of a regional anesthesia technique (see reference)

次要结局

  • Time to complete the task(Through scenario completion (approximatively 25 minutes))
  • Stress level experienced(Through scenario completion (approximatively 25 minutes))

研究者

发起方
Ciusss de L'Est de l'Île de Montréal
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marie-Eve Belanger

Associate Professor, MD, FRCPC, PGdip(ed)

Ciusss de L'Est de l'Île de Montréal

研究点 (1)

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