Back to results

Diagnostic Errors in Anaphylactic Shock (ANASim)

Primary Purpose

Diagnostic Error

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Diagnostic context

About this trial

This is an interventional diagnostic trial for Diagnostic Error

Eligibility Criteria

24 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Physicians taking part in voluntary simulator workshops

Exclusion Criteria:

Refusal to participate or to being videorecorded

Sites / Locations

University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Expected

Unexpected, no distractor

Unexpected, with distractor

Arm Description

Anaphylactic shock occurs after the injection of a drug known to cause allergic reactions

Anaphylactic shock occurs unexpectedly, but their is no medical distractor

Anaphylactic shock occurs unexpectedly. Scenario is set up such, that a tension pneumothorax may be a likely explanation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04825106

First Posted

March 22, 2021

Last Updated

May 10, 2023

Sponsor

University Hospital, Basel, Switzerland

1. Study Identification

Unique Protocol Identification Number

NCT04825106

Brief Title

Diagnostic Errors in Anaphylactic Shock

Acronym

ANASim

Official Title

Context-dependent Diagnostic Accuracy in Anaphylactic Shock

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

January 1, 2008 (Actual)

Primary Completion Date

November 30, 2022 (Actual)

Study Completion Date

December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diagnostic Error

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

270 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Expected

Arm Type

Active Comparator

Arm Description

Anaphylactic shock occurs after the injection of a drug known to cause allergic reactions

Arm Title

Unexpected, no distractor

Arm Type

Active Comparator

Arm Description

Anaphylactic shock occurs unexpectedly, but their is no medical distractor

Arm Title

Unexpected, with distractor

Arm Type

Active Comparator

Arm Description

Anaphylactic shock occurs unexpectedly. Scenario is set up such, that a tension pneumothorax may be a likely explanation

Intervention Type

Other

Intervention Name(s)

Diagnostic context

Intervention Description

A life-threatening situation occurs in 3 different contexts

Primary Outcome Measure Information:

Title

Correct diagnosis of anaphylactic shock

Description

Diagnosis of anaphylactic shock is explicitly stated by at least one team member within a time frame of 15 minutes after onset

Time Frame

15 minutes

Secondary Outcome Measure Information:

Title

Treatment of anaphylactic shock with epinephrine ≥ 0.3mg intravenously

Description

Anaphylactic shock is correctly treated with epinephrine in an appropriate dose (≥ 0.3mg intravenously) within a time frame of 5 minutes after diagnosis

Time Frame

5 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

24 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Physicians taking part in voluntary simulator workshops Exclusion Criteria: Refusal to participate or to being videorecorded

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephan Marsch

Organizational Affiliation

University Hospital, Basel, Switzerland

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital

City

Basel

State/Province

ZIP/Postal Code

4031

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Secondary data can be shared Videorecordings are strictly confidential and cannot be shared

Learn more about this trial

Diagnostic Errors in Anaphylactic Shock

We'll reach out to this number within 24 hrs