Clinical trial NCT04846660: Impact of Production Pressure in the Block Room on Patient Safety
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Safety
Anesthesia
Keywords: Production pressure
Time pressure
Lead sponsor: Ciusss de L'Est de l'Île de Montréal
Sponsor class: OTHER
Collaborators: name: Université de Montréal
name: Maisonneuve-Rosemont Hospital
First posted: 2021-04-15
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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:

Performances were filmed in order to be reviewed by three regional anesthesia experts. Participants were then asked to fulfill a questionnaire in another room. This form included a validated task load index grid (NASA) to quantify the amount of stress experienced, demographic data and a realism score.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

- To refuse to participate

Primary outcomes:
measure: RAPS score
timeFrame: Through scenario completion (approximatively 25 minutes)
Secondary outcomes:
measure: Time to complete the task
timeFrame: Through scenario completion (approximatively 25 minutes)
measure: Stress level experienced
timeFrame: Through scenario completion (approximatively 25 minutes)
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosemont
state: Quebec
Study officials:
References: