Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT04506333
Eligibility Criteria:
Inclusion Criteria:
* Parent permission
* Assent for participants aged 7-12
* Additional sequential selection criteria (described below)
Exclusion Criteria:
* Withdrawal of permission or assent
* Younger than 3 or older than 12 years of age
* Uncooperative participants, defined as refusing instructions from study personnel, coordinators, or observers
* Physical preclusion to taking blood pressure
* Participants who have any reference blood pressure measurement exceeding the 95th percentile plus 30mmHg for their age, sex, and height (urgent blood pressure level as defined by the American Academy of Pediatrics)
* Participants with systolic blood pressure difference of greater than 12mmHg or diastolic blood pressure difference of greater than 8mmHg between any two reference measurements
Sequential Selection Criteria:
Participants will be selected sequentially during study events. Per ISO/ESH/AAMI standards, participants must meet the following characteristics:
* at least 30% male and 30% female
* at least 1/6 using each of the three available cuff sizes (small, medium, large)
* for each cuff size, at least 40% in the upper half of the arm circumference range and at least 40% in the lower half of the arm circumference range.
If including a participant would require that additional participants be enrolled to meet the above criteria, that participant will not be included. For example, if only 2 small cuff participants are needed to complete the study, but a prospective participant would require a large cuff AND including that participant will require additional small or medium cuff participants to complete the study, then that prospective participant will not be included.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
12 Years
Study:
NCT04506333
Study Brief:
Protocol Section:
NCT04506333