Childhood Adenotonsillectomy Trial

1.4 Placement of AMBP Cuff

The cuff should be placed on the child’s non-dominant arm and in the correct position. The arrow should point to mid point of anticubital fossa (or “inside elbow”). Measure 1” (2 finger breaths) above the crease in the antecubital fossa of the child’s non-dominant arm (suggest marking the child’s arm – this may be helpful to the parent if the cuff is released during the 24 hour period and has to be replaced). Make sure the cuff is snug enough that it will not slide but not too tight (if no more that 2 finger breaths can slide under the cuff than it is not too tight or too loose).

1.4.1 Participant

The participating child will be asked to wear the blood pressure monitor for a period of 24 hours beginning on the day of the baseline visit (after all other testing has been performed and completed, and if the subsequent day is not a school day) and again at the primary end point visit, Month 7. (If the subsequent day is a school day, the participant will be asked to use the ABPM on the first non-school day as described above. The purpose and proper use of the monitor/equipment must be clearly explained and demonstrated to the parent/legal guardian and to the participant.

1.4.2 Talking Points

The coordinator may want to inform the child that h/she may feel:

“Arm will get a hug every 30 minutes (or half hour)”

“Wearing the cuff can be fun; you can play “Mr. Freeze” (no sports, etc.)

“If you feel the cuff squeezing your arm, do not remove – just stand still like a statue”

1.4.3 Parent or Legal Guardian

The coordinator will instruct the child/parent/legal guardian on the proper use of the blood pressure device and recording diary; stressing the importance of recording sleep and awake times. An instruction sheet will be provided as a quick reference guide (refer to the supplemental Diary Instructions Form attached. The parent/legal guardian will be instructed to complete the diary and return it with the monitor in the pre-paid shipping container within 2 days.

1.4.4 Research Coordinator

The research coordinator will be responsible for programming and calibrating (or initializing) the AMBP, instructing the parent and child on its proper use, distribution the diary and instruction sheet and recording the equipment on the Device Accountability Log [DEVICE]. Also arrangements must be made for return of the equipment and completed diary prior to leaving the facility. A prepaid shipping container within 2 days