Diagnosis and Allergen Identification of Perioperative Anaphylaxis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2+
SponsorPeking University First Hospital
About this trial
Perioperative anaphylaxis may lead to fatal respiratory and/or circulatory events, yet both clinical diagnosis and management are challenging. Serum tryptase is an indicator that can provide important retrospective diagnostic value for anaphylaxis. Another key point in perioperative anaphylaxis management is to identify the allergens, and thus avoid re-exposure during later perioperative management. Skin testing is an important way to identify allergens.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 2 years or over;
Suspected anaphylaxis in the operating rooms, or history of suspected anaphylaxis in the operating room.
Disqualifiers
Refuse to participate;
Other conditions that are considered unsuitable for study participation.
Trial population
Patients with suspected anaphylaxis in the operating room.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
115 Participants
are grouped into 1 trial groupGroup A: Suspected anaphylaxis
Trial outcomes
Primary outcomes
1
Incidence of severe perioperative anaphylaxis
Perioperative anaphylaxis is defined as anaphylaxis that is confirmed by clinical signs and symptoms and changes of serum tryptase level according to the World Allergy Organization Anaphylaxis Guidance 2020 and occurred in the operating room. Severe perioperative anaphylaxis indicates grade 3 or above according to the World Allergy Organization systemic allergic reaction grading system. The incidence is calculated as the number of cases with severe perioperative anaphylaxis divided by the total number of cases who undergo surgery in the operating room during the study period.
Time frame
On the day of surgery in the operating roomSecondary outcomes
1
Diagnostic rate of anaphylaxis in patients with suspected perioperative anaphylaxis.
Perioperative anaphylaxis is defined as anaphylaxis that is confirmed by clinical signs and symptoms and changes of serum tryptase level according to the World Allergy Organization Anaphylaxis Guidance 2020 and occurred in the operating room. The rate is calculated as the number of cases with confirmed anaphylaxis divided by the total number of cases with suspected anaphylaxis in the operating room during the study period.
Time frame
On the day of surgery in the operating room2
Incidence of perioperative anaphylaxis
Perioperative anaphylaxis is defined as anaphylaxis that is confirmed by clinical signs and symptoms and changes of serum tryptase level according to the World Allergy Organization Anaphylaxis Guidance 2020 and occurred in the operating room. The incidence is calculated as the number of cases with any grade perioperative anaphylaxis divided by the total number of cases who undergo surgery in the operating room during the study period.
Time frame
On the day of surgery in the operating room3
Allergen detection in patients with perioperative anaphlaxis
Allergen is detected with skin testing in patients with confirmed perioperative anaphylaxis. Skin testing will be performed at least 4-6 weeks after the confirmed anaphylaxis.
Time frame
At least 4-6 weeks after the confirmed perioperative anaphylaxisOther outcomes
1
Rate of surgical suspension due to suspected perioperative anaphylaxis.
The rate is calculated as the number of patients with surgical suspension due to suspected perioperative anaphylaxis divided by the total number of patients with suspected/confirmed perioperative anaphylaxis in the operating room during the study period.
Time frame
On the day of surgery suspected perioperative anaphylaxis2
Rate of unplanned ICU admission due to suspected perioperative anaphylaxis
The rate is calculated as the number of patients with unplanned ICU admission due to suspected perioperative anaphylaxis divided by the total number of patients with suspected/confirmed perioperative anaphylaxis in the operating room during the study period.
Time frame
Within 24 hours of suspected perioperative anaphylaxis3
Rate of recurrence of perioperative anaphylaxis
Perioperative anaphylaxis is defined as anaphylaxis that is confirmed by clinical signs and symptoms and changes of serum tryptase level according to the World Allergy Organization Anaphylaxis Guidance 2020 and occurred in the operating room. The rate is calculated as the number of patients with recurrence of suspected perioperative anaphylaxis divided by the total number of patients with confirmed perioperative anaphylaxis in the operating room during the study period.
Time frame
On the day of surgery in the operating roomSponsors and contacts
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Source ClinicalTrials.gov