BronchospasmNCT05025709
Bronchospasm During Anesthetic Induction: Study of Clinical Characteristics and Treatments Administered According to Etiology
An observational study of Bronchospasm, run by Central Hospital, Nancy, France at 1 site in France.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bronchospasm
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2020to 31 Mar 2021
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
France1 site
Dermato-allergology department of the Nancy University Hospital
Nancy, 54000
About this study
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.
- Conditions
- Bronchospasm
- Keywords
- bronchial spasm, general anaesthesia, allergy, anaphylaxis
- Medical subject headings
- Bronchial Spasm, Hypersensitivity, Anaphylaxis
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline (J0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start1 Sep 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchospasmStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MOUTON-FAIVRE Claudie, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025709
- Sponsor's protocol ID
- 2020PI277
- Status last verified
- Aug 2021
- First submitted
- 23 Aug 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchospasm During Anesthetic Induction: Study of Clinical Characteristics and Treatments Administered According to Etiology
- ClinicalTrials.gov ID
- NCT05025709
- Acronym / sponsor ID
- 2020PI277
- Conditions
- Bronchospasm
- Keywords
- bronchial spasm, general anaesthesia, allergy, anaphylaxis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 27 Aug 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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical reactions
Time frame: Baseline (J0)
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).
Treatments provided
Time frame: Baseline (J0)
To determine whether the treatments provided to patients with non-allergic bronchospasm are different from those provided to patients with allergic bronchospasm.
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 27 Aug 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchospasm, run by Central Hospital, Nancy, France at 1 site in France.
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 27 Aug 2021. 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 France. 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?
Clinical reactions (time frame: Baseline (J0)). The study lists 2 primary outcomes in all. 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 27 Aug 2021.