Diagnostic Errors in Anaphylactic Shock

Diagnostic Error Clinical Trial

— ANASim  

Official title:

Context-dependent Diagnostic Accuracy in Anaphylactic Shock

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04825106
• Other study ID #: 4031-Sim-ANA
• Status: Completed
• Phase: N/A
• Start date: January 1, 2008
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2023
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: December 31, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Years and older

Eligibility

Inclusion Criteria:

• Physicians taking part in voluntary simulator workshops

Exclusion Criteria:

• Refusal to participate or to being videorecorded

Related Conditions & MeSH terms

• Anaphylaxis
• Diagnostic Error

Intervention

Other:
• Diagnostic context
A life-threatening situation occurs in 3 different contexts

Locations

Country	Name	City	State
Switzerland	University Hospital	Basel	BS

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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