NCT05025709

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed
Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

7 months

First QC Date

August 23, 2021

Last Update Submit

August 26, 2021

Conditions

Keywords

bronchial spasmgeneral anaesthesiaallergyanaphylaxis

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients included were those referred to the allergy consultation (dermato-allergology department of the Nancy University Hospital), over a period from October 2017 to March 2021, for investigation of an immediate hypersensitivity reaction, involving a bronchospasm explicitly identified by the anaesthetist, which occurred during an anaesthetic procedure. There were no exclusion criteria.

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dermato-allergology department of the Nancy University Hospital

Nancy, 54000, France

Location

MeSH Terms

Conditions

Bronchial SpasmHypersensitivityAnaphylaxis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesImmune System DiseasesHypersensitivity, Immediate

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 23, 2021

First Posted

August 27, 2021

Study Start

September 1, 2020

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

August 27, 2021

Record last verified: 2021-08

Locations