Diagnostic Errors in Anaphylactic Shock (ANASim)

Context-dependent Diagnostic Accuracy in Anaphylactic Shock

Diagnostic accuracy and quality of management in anaphylactic shock is assessed in three conditions: expected, unexpected with no distractor, unexpected with distractor

Study Overview

• Status: Completed
• Conditions: Diagnostic Error
• Intervention / Treatment: Other: Diagnostic context

Detailed Description

participants: physicians taking part in voluntary workshops. Participants are allocated to teams of three design: prospective, randomized, single-blind setting: simulated anaphylactic shock intervention: participants are allocated to 3 versions of the scenario: 1) expected, 2) unexpected but no distractor, 3) unexpected with distractor

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • BS
    • Basel, BS, Switzerland, 4031
      • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Physicians taking part in voluntary simulator workshops

Exclusion Criteria:

• Refusal to participate or to being videorecorded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Expected; Anaphylactic shock occurs after the injection of a drug known to cause allergic reactions	Other: Diagnostic context; A life-threatening situation occurs in 3 different contexts
Active Comparator: Unexpected, no distractor; Anaphylactic shock occurs unexpectedly, but their is no medical distractor	Other: Diagnostic context; A life-threatening situation occurs in 3 different contexts
Active Comparator: Unexpected, with distractor; Anaphylactic shock occurs unexpectedly. Scenario is set up such, that a tension pneumothorax may be a likely explanation	Other: Diagnostic context; A life-threatening situation occurs in 3 different contexts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correct diagnosis of anaphylactic shock	Diagnosis of anaphylactic shock is explicitly stated by at least one team member within a time frame of 15 minutes after onset	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment of anaphylactic shock with epinephrine ≥ 0.3mg intravenously	Anaphylactic shock is correctly treated with epinephrine in an appropriate dose (≥ 0.3mg intravenously) within a time frame of 5 minutes after diagnosis	5 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Stephan Marsch, University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2008
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: March 30, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Anaphylaxis
• Other Study ID Numbers: 4031-Sim-ANA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Secondary data can be shared Videorecordings are strictly confidential and cannot be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No