Impact of Production Pressure in the Block Room on Patient Safety

NCT04846660 | Completed

• 1 other identifier: 2021-2533
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Safety; Anesthesia

Keywords

Production pressure; Time pressure

Outcome Measures

Primary Outcomes (1)

• RAPS score

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

  Through scenario completion (approximatively 25 minutes)

Secondary Outcomes (2)

• Time to complete the task

  Through scenario completion (approximatively 25 minutes)

• Stress level experienced

  Through scenario completion (approximatively 25 minutes)

Study Arms (2)

Production pressured environment

EXPERIMENTAL

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

Other: Production pressure

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.

Interventions

Production pressure OTHER

Participant exposed to production pressure

Production pressured environment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- To refuse to participate

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead
• Université de Montréal: collaborator
• Maisonneuve-Rosemont Hospital: collaborator

Study Sites (1)

Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

MeSH Terms

Conditions

Time Pressure

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD, FRCPC, PGdip(ed)

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 15, 2021
• Study Start: March 20, 2021
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: August 20, 2021

Record last verified: 2021-08

Locations

CA (1)