Concordance Between the Electromedical Device Nexkin DSPT and the Manual Procedure in the Measurement of Papules in Allergy Skin Testing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Agreement in wheal size measures in allergy skin testing between the electro-medical device Nexkin DSPT and the manual measurement procedure
研究概览
简要总结
Clinical trial with the aim to evaluate the level of agreement in wheal size measures in allergy skin prick testing (SPT) between the electro-medical device Nexkin DSPT® and the manual measurement procedure used in the daily practice.
详细描述
The purpose of the trial is to evaluate the concordance of measurements obtained by the Nexkin DSPT device versus the measurements obtained manually.
A prospective clinical trial study was conducted at Clínica Universidad de Navarra. SPT will be tested in the same way as during a routine visit, with the only difference being that the images of the arm required for the device to operate will be captured. Nexkin DSPT device is a non-invasive device, which does not perform the procedure of puncture and appearance of papules. The device is only used to read the test results. There is no risk to the patient or the healthcare professionals involved in capturing images with the device. Device does not provide a diagnosis and it is not a substitute for sound medical judgment.
The study will prospectively include patients attending the allergy consultation (sample size calculated in 93 patients) with positive (histamine) and negative (saline solution) controls. Fifteen minutes later, two consecutive readings with the device and two manual readings were performed by two different nurses. The area of the histamine wheals was measured automatically by Nexkin DSPT and after the manual procedure measured manually by planimetry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient to be tested with aeroallergen and/or food battery prick tests.
- •Patient over 12 years of age.
- •Patient, or his/her representative, who has given consent to participate in the study.
- •Patient who has not taken an antihistamine for more than 3 days.
- •Women of childbearing age who, at the time of taking the clinical history, declare that they are not pregnant.
排除标准
- •Patients who are to be tested with a prick number greater than
- •Patients who are to be tested with a prick number less than 40, but for whom it is necessary to place more than two rows of allergens in at least one of the arms.
- •Patients who have taken an antihistamine within the previous 3 days.
- •Patients who are being treated with antidepressants or other drugs with an antihistamine effect.
- •Patients who suffer severe atopic dermatitis affecting the forearms.
- •Patients with dermographism.
- •Patients who are to undergo intradermal testing.
- •Pregnant women or women suspected of pregnancy.
结局指标
主要结局
Agreement in wheal size measures in allergy skin testing between the electro-medical device Nexkin DSPT and the manual measurement procedure
时间窗: 5 minutes
Fifteen minutes after the punctures have been performed, a double reading of the forearm shall be taken with the device. The first reading will be stored for later analysis, and the second reading will be used afterwards. The healthcare professional will then perform the manual reading and generate the manual result sheet as is standard practice. The health professional visually examines the forearm and compares his observation with the identification presented by the device. The result of the identifications made by the device as well as the interactions of the healthcare professional on the screen shall be recorded on the device. Diameter measurements are measured in millimetres (mm) and area measurements are measured in square millimetres (mm2).
次要结局
- Test-retest reliability of device reading.(5 minutes)
- Variability in measurements of histamine wheals made by different health professionals.(5 minutes)