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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05025709
Other study ID # 2020PI277
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date March 31, 2021

Study information

Verified date August 2021
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Bronchospasm during anaesthesia is a rare but potentially life-threatening event. They are classically part of IgE-dependent anaphylaxis but can also occur as an independent clinical entity, triggered by inflammatory factors such as smoking, chronic bronchitis, asthma, overweight and mechanical factors such as tracheal intubation. The etiological diagnosis is currently established during an allergy-anaesthesia consultation after skin testing for drugs used for induction of anaesthesia and antibiotic therapy when it is attributable. The aim of this study was to determine the characteristics that differ between 2 groups: isolated non-allergic bronchospasm and bronchospasm as part of an immediate allergic hypersensitivity reaction.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date March 31, 2021
Est. primary completion date March 31, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients referred to the allergy consultation for investigation of an immediate hypersensitivity reaction, involving a bronchospasm explicitly identified by the anaesthetist, which occurred during an anaesthetic procedure. Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Dermato-allergology department of the Nancy University Hospital Nancy

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical reactions To show that clinical reactions presented by patients with non-allergic bronchospasm are different from those presented with allergic bronchospasm (Presence or absence of associated signs such as hypotension, heart rate variation, skin signs, desaturation, EtCO2 variation). Baseline (J0)
Primary Treatments provided To determine whether the treatments provided to patients with non-allergic bronchospasm are different from those provided to patients with allergic bronchospasm. Baseline (J0)
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