Pilot study to investigate the value of sensors for early allergic response detection during a food challenge and drug provocation test.
Completed
- Conditions
- drug allergyFood Allergy10001708
- Registration Number
- NL-OMON49920
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 65
Inclusion Criteria
In order to be eligible to participate in this study, a subject must meet the
following criteria:
o Undergo a food challenge in routine care
o At least 18 years of age at the start of the study
o Written informed consent
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
o < 18 years of age
o Pacemaker or Implanted Cardioverter Defibrillator (ICD)
o Breastfeeding women
o Known allergic reaction to ECG-stickers
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is: Change in continuous heart rate, respiratory rate,<br /><br>axillary temperature, non-invasive blood pressure and oxygen saturation between<br /><br>baseline and verum day and when applicable between placebo and verum day.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoint is: The time that a change in continuous heart rate,<br /><br>respiratory rate, axillary temperature, non-invasive blood pressure and oxygen<br /><br>saturation is seen, before the report of complaints by patient</p><br>