NCT04825106

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
13.2 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

14.9 years

First QC Date

March 22, 2021

Last Update Submit

May 10, 2023

Conditions

Diagnostic Error

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Treatment of anaphylactic shock with epinephrine ≥ 0.3mg intravenously

    5 minutes

Study Arms (3)

Expected

ACTIVE COMPARATOR

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

Other: Diagnostic context

Unexpected, no distractor

ACTIVE COMPARATOR

Anaphylactic shock occurs unexpectedly, but their is no medical distractor

Other: Diagnostic context

Unexpected, with distractor

ACTIVE COMPARATOR

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

Other: Diagnostic context

Interventions

Diagnostic contextOTHER

A life-threatening situation occurs in 3 different contexts

ExpectedUnexpected, no distractorUnexpected, with distractor

Eligibility Criteria

Age24 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physicians taking part in voluntary simulator workshops

You may not qualify if:

  • Refusal to participate or to being videorecorded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Basel, Canton of Basel-City, 4031, Switzerland

Location

Study Officials

  • Stephan Marsch

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2021

First Posted

April 1, 2021

Study Start

January 1, 2008

Primary Completion

November 30, 2022

Study Completion

December 31, 2022

Last Updated

May 11, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

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

Locations

CH(1)