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
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
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
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
Marie-Eve Belanger
Associate Professor, MD, FRCPC, PGdip(ed)
Ciusss de L'Est de l'Île de Montréal
