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Innovation and Clinical Validation of Diagnostic Tools for Perioperative Allergic Reactions: Standardization of Skin Tests Based on Thermal Imaging Technology and Construction of a Multimodal Risk Assessment System

Innovation and Clinical Validation of Diagnostic Tools for Perioperative Allergic Reactions: Standardization of Skin Tests Based on Thermal Imaging Technology and Construction of a Multimodal Risk Assessment System

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114361
Enrollment
Unknown
Registered
2025-12-10
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative Anaphylaxis

Interventions

Gold Standard:At present, one of the gold-standard methods for allergen detection is skin testing. The criteria for a positive result are as follows: 1.Skin Prick test: Performed on the volar aspect o
the presence of erythema or pruritus further supports a positive reaction. 2. Skin Intradermal test: Inject 0.02–0.03 mL of the diluted test solution intradermally into the volar aspect of the forearm
the presence of erythema and pruritus further supports a positive reaction. 3.Positive control: Inject 0.02–0.03 mL of the diluted test solution intradermally into the volar aspect of the forearm to f
the presence of erythema and pruritus further supports a positive reaction. Basophil activation test: this is currently one of the mainstream methods for allergen diagnosis, with high specificity
when combined with skin testing, it can achieve high accuracy in identifying causative allergens. The specific procedure is as follows: (1) Draw 5 mL of peripheral blood from the patient and immediate
(2) Add 50 µL of the corresponding stimulant to each pre-labeled tube for that patient
(3) Add 100 µL of stimulation buffer and 50 µL of the patient’s whole-blood sample to each tube
(4) After stimulation, ad

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 80 Years

Inclusion criteria

Inclusion criteria: Diagnostic criteria for perioperative allergic reactions are defined as clinical manifestations occurring within 15 minutes of anaesthetic administration, involving but not limited to the following organ systems: 1. Circulatory system: hypotension, tachycardia, or rapid progression to severe arrhythmias, circulatory collapse, or cardiac arrest; 2. Respiratory system: Increased salivation and sputum secretion, laryngospasm, bronchospasm, wheezing and moist rales in the lungs; 3. Digestive system: nausea, vomiting, or diarrhoea; 4. Skin and mucous membranes: skin flushing, various rashes (particularly large urticaria-like papules), subcutaneous angioedema, generalised skin oedema, oedema of nasal, ocular, and pharyngeal mucosa; 5. Two investigators independently assess each allergic case; discrepancies are resolved by a third investigator; 6. At least one positive skin test and/or basophil activation test for the suspected drug; mast cell activation testing to be supplemented where necessary.

Exclusion criteria

Exclusion criteria: Exclusion Criteria 1. Presence of the aforementioned systemic manifestations, but inability to exclude non-allergic conditions requiring differential diagnosis, such as asthma attacks, haemorrhagic shock, excessive anaesthesia depth, or pulmonary embolism; 2. Inability to discontinue medications such as antihistamines or corticosteroids that may interfere with diagnostic tests (e.g., skin prick tests, basophil activation tests, mast cell activation tests); 3. Concurrent severe immune system disorders, haematological conditions, or dermatological diseases that may affect allergen test results; 4. Patients experiencing an allergic reaction within 4–6 weeks prior to testing; 5. Patients refusing to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Skin temperature;

Secondary

MeasureTime frame
wheal size in skin testing;Basophil activation test result;

Countries

China

Contacts

Public Contactjing zhao

China-Japan Friendship Hospital

zhaojing1009@aliyun.com+86 10 8420 5876

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026