Allergens, Anaphylaxis, Perioperative/Postoperative Complications, Skin Testing, Tryptase
Conditions
Keywords
Perioperative/Postoperative Complications, Anaphylaxis, Tryptase, Allergens, Skin Testing
Brief summary
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.
Detailed description
Perioperative anaphylaxis are rare, but may be fatal. The combined use of anesthetic drugs and other medications, and the additional effects of surgical procedures, make the diagnosis and differential diagnosis rather complicated. Subsequent allergy investigations and allergen identification are often difficult. The change of tryptase levels is an important biomarker in differentiating anaphylaxis from other causes. It is recommended that, in case of any suspicion of perioperative anaphylaxis, serum samples for tryptase detection should be collected as soon as possible after the onset of symptoms and then repeated 24 h later. Skin testing including skin prick tests (SPT) and intradermal tests (IDT) is universally used in identifying allergens. Skin testing will be performed 4-6 weeks after the onset of perioperative anaphylaxis. This prospective cohort study is designed to clarify the rate of perioperative anaphylaxis with testing serum tryptase level and to identify the underlying allergens by conducting skin testing in surgical patients with suspected perioperative anaphylaxis.
Interventions
None listed
Sponsors
Peking University First Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 2 years or over; * Suspected anaphylaxis in the operating rooms, or history of suspected anaphylaxis in the operating room.
Exclusion criteria
* Refuse to participate; * Other conditions that are considered unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of severe perioperative anaphylaxis | On the day of surgery in the operating room | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic rate of anaphylaxis in patients with suspected perioperative anaphylaxis. | On the day of surgery in the operating room | 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. |
| Incidence of perioperative anaphylaxis | On the day of surgery in the operating room | 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. |
| Allergen detection in patients with perioperative anaphlaxis | At least 4-6 weeks after the confirmed perioperative anaphylaxis | 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. |
Countries
China
Contacts
CONTACTDong-Xin Wang, MD, PhD
CONTACTYa-Wei Li, MD
PRINCIPAL_INVESTIGATORDong-Xin Wang, MD, PhD
Peking University First Hospital
Outcome results
None listed