Diagnostic ErrorANASimNCT04825106
Diagnostic Errors in Anaphylactic Shock
A study testing Diagnostic context in people with Diagnostic Error, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Diagnostic accuracy and quality of management in anaphylactic shock is assessed in three conditions: expected, unexpected with no distractor, unexpected with distractor Read more about this study
- Who is it for?
- Ages 24 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diagnostic Error
- What is being tested?
- Diagnostic context
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2008to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physicians taking part in voluntary simulator workshops
Who cannot join
- Refusal to participate or to being videorecorded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Diagnostic Error
- Being tested
- Diagnostic context
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic contextOther
A life-threatening situation occurs in 3 different contexts
| Study group | Role | What they receive |
|---|---|---|
| Expected | Active comparator | Anaphylactic shock occurs after the injection of a drug known to cause allergic reactions Receives: Other: Diagnostic context |
| Unexpected, no distractor | Active comparator | Anaphylactic shock occurs unexpectedly, but their is no medical distractor Receives: 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 Receives: Other: Diagnostic context |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 minutes
Secondary outcomes (1)
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
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Jan 2008
- Primary completion30 Nov 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnostic ErrorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan Marsch, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825106
- Sponsor's protocol ID
- 4031-Sim-ANA
- Acronym
- ANASim
- Status last verified
- May 2023
- First submitted
- 22 Mar 2021
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Secondary data can be shared Videorecordings are strictly confidential and cannot be shared
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Context-dependent Diagnostic Accuracy in Anaphylactic Shock
- ClinicalTrials.gov ID
- NCT04825106
- Acronym / sponsor ID
- ANASim / 4031-Sim-ANA
- Conditions
- Diagnostic Error
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Expected | Active comparator | Other: Diagnostic contextAnaphylactic shock occurs after the injection of a drug known to cause allergic reactions |
| Unexpected, no distractor | Active comparator | Other: Diagnostic contextAnaphylactic shock occurs unexpectedly, but their is no medical distractor |
| Unexpected, with distractor | Active comparator | Other: Diagnostic contextAnaphylactic shock occurs unexpectedly. Scenario is set up such, that a tension pneumothorax may be a likely explanation |
Who may qualify
- Ages
- 24 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Physicians taking part in voluntary simulator workshops
Key exclusion criteria (1 listed)
- Refusal to participate or to being videorecorded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic contextA life-threatening situation occurs in 3 different contexts | Other | Expected, Unexpected, no distractor, Unexpected, with distractor |
Primary outcome
Correct diagnosis of anaphylactic shock
Time frame: 15 minutes
Diagnosis of anaphylactic shock is explicitly stated by at least one team member within a time frame of 15 minutes after onset
1 secondary outcome
Treatment of anaphylactic shock with epinephrine ≥ 0.3mg intravenously
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: No. Secondary data can be shared Videorecordings are strictly confidential and cannot be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Marsch principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic context in people with Diagnostic Error, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correct diagnosis of anaphylactic shock (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.