Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suspected anaphylaxis | Adult patients with suspected anaphylaxis in the operating rooms, or with history of suspected anaphylaxis in the operating room. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. | On the day of surgery in the operating room |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | On the day of surgery suspected perioperative anaphylaxis |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with suspected anaphylaxis in the operating room.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong-Xin Wang, MD, PhD | Contact | 86-10-83572784 | wangdongxin@hotmail.com | |
| Ya-Wei Li, MD | Contact | 86-10-83572460 | liyawei@bjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Dong-Xin Wang, MD, PhD | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34343358 | Background | Muraro A, Worm M, Alviani C, Cardona V, DunnGalvin A, Garvey LH, Riggioni C, de Silva D, Angier E, Arasi S, Bellou A, Beyer K, Bijlhout D, Bilo MB, Bindslev-Jensen C, Brockow K, Fernandez-Rivas M, Halken S, Jensen B, Khaleva E, Michaelis LJ, Oude Elberink HNG, Regent L, Sanchez A, Vlieg-Boerstra BJ, Roberts G; European Academy of Allergy and Clinical Immunology, Food Allergy, Anaphylaxis Guidelines Group. EAACI guidelines: Anaphylaxis (2021 update). Allergy. 2022 Feb;77(2):357-377. doi: 10.1111/all.15032. Epub 2021 Sep 1. | |
| 38587791 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D000707 | Anaphylaxis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
Not provided
Not provided
Not provided
Not provided
Not provided
Serum
| On the day of surgery in the operating room |
| 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. | On the day of surgery in the operating room |
| 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. | At least 4-6 weeks after the confirmed perioperative anaphylaxis |
| 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. | Within 24 hours of suspected perioperative anaphylaxis |
| 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. | On the day of surgery in the operating room |
| Beijing Anorectal Hospital (Beijing Erlong Road Hospital) | Recruiting | Beijing | Beijing Municipality | China |
|
| Beijing Children's Hospital, Capital Medical University; National Center for Children's Health, China | Recruiting | Beijing | Beijing Municipality | China |
|
| Beijing Friendship Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | China |
|
| Beijing Tongren Hospital, Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | China |
|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | China |
|
| Background |
| Tran R, Pedersen K, Kolawole H, Roessler P, Scolaro R. Australian and New Zealand Anaesthetic Allergy Group/Australian and New Zealand College of Anaesthetists perioperative anaphylaxis management guideline 2022. Anaesth Intensive Care. 2024 May;52(3):147-158. doi: 10.1177/0310057X231215823. Epub 2024 Apr 8. |
| 34247332 | Background | Manian DV, Volcheck GW. Perioperative Anaphylaxis: Evaluation and Management. Clin Rev Allergy Immunol. 2022 Jun;62(3):383-399. doi: 10.1007/s12016-021-08874-1. Epub 2021 Jul 10. |
| D007154 | Immune System Diseases |