SOP for Blood Pressure Measurements
The patient must avoid smoking, drinking a caffeine beverage, and exercising for at least 30 minutes before the blood pressure is measured. The patient should urinate prior to blood pressure assessment. Neither the patient nor the staff should talk during the procedure. All clothing covering the location of cuff placement should be removed. Blood pressure will be measured with the auscultatory method (sphygmomanometer and stethoscope) or an automated blood pressure measurement system with the patient in the seated position in a quiet room after 5 minutes of quiet rest. Potential stressors should be avoided to prevent any potential white coat effect on blood pressure levels. Three (3) repeated blood pressure measurements will be done. The following variables will be recorded in the eCRF:
- Resting blood pressure (mmHg) (systolic, diastolic, and calculated mean arterial pressure [MAP]), mean of 3 recordings for each rounded up to the nearest integer
- Pulse (bpm), after 5 minutes sitting
Vital signs measurements will be repeated if clinically significant or machine/equipment errors occur. Out-of-range blood pressure, or heart rate measurements will be repeated at the investigator’s discretion. Any confirmed, clinically significant vital sign measurements must be recorded as AEs. Irregular pulse in patients with no prior known arrythmia must be followed up with an ECG assessment.
