sStandard Operating Procedure Vital Sign

1. PURPOSE This Standard Operating Procedure (SOP) outlines the procedure for obtaining blood pressure (BP), pulse (P) and temperature in the context of a clinical research study. 2. SCOPE This SOP applies to those trials carried out within the scope of ECTU where vital signs are required by the study specific protocol:  To determine a patient’s eligibility to meet inclusion criteria for a trial.  To provide a baseline measurement with which to compare those taken subsequently during the course of the trial.  Measurements may also be taken to ensure participant safety in relation to adverse events. This SOP applies to all research staff within ECTU who are delegated the responsibility of measuring a participant’s vital signs for the purpose of the study. 3. PROCEDURE 3.1 Check the study protocol for specific study instructions on measuring vital signs 3.2 Ensure that the equipment required (automated blood pressure monitor) is within the calibration period. Refer to the manufacturer’s guidelines for equipment use if not specified in the study protocol. 3.3 Measuring Blood Pressure and Pulse 3.3.1 3.3.2 3.3.3 3.3.4 3.3.5 3.3.6 3.3.7 3.3.8 3.3.9 3.3.10 Explain the procedure to the participant including the avoidance of talking. Blood pressure should be taken using a semi-automated blood pressure machine unless otherwise stated in the study protocol. Because automated devices may not measure blood pressure accurately if there is pulse irregularity (for example, due to atrial fibrillation), palpate the radial or brachial pulse before measuring blood pressure. If pulse irregularity is present, measure blood pressure manually using direct auscultation over the brachial artery The patient must remain seated for a minimum of 5 minutes prior to the recording the blood pressure unless otherwise stated in the study protocol. Ask the participant to remove any tight clothing and jewellery which might restrict the arm. If the study protocol does not specify position of participant, instruct him/her to sit with legs uncrossed and both feet on the floor. Observe protocol for guidance on whether non-dominant or dominant arm should be used for blood pressure and pulse measurements. Select the correct cuff size for the participant by measuring the circumference of the selected arm and following manufacturer’s recommendations. The selected arm should be supported no higher than heart level and the cuff applied to sit 1 to 2 cm above the elbow joint snugly, however, loose enough to slip one finger between the cuff and the participant’s skin. Two consecutive blood pressure and pulse recordings should be taken after a minimum of 5 minutes in the sitting position unless otherwise stated in the study protocol. Page 2 of 3 3.4 Blood Pressure and Pulse Readings 3.4.1 3.4.2 3.4.3 3.4.4 3.5 If blood pressure is 140/90mmHg or higher take a second measurement, if this is substantially different from the first take a third measurement. Record the lower of the last two as clinic blood pressure. If the readings differ by >15mmHg or are outside the range required by the protocol, further recordings are required until two of the readings are within 15mmHg for both systolic and diastolic BP, or the out of range value is confirmed by two consecutive recordings. 1 The pulse should be between 60 - 100 beats/min, with less than or equal to 10 beats/min difference between the two recordings, check individual study protocol If either of the first two pulse readings are outside this range or differ by more than 10 beats/min, take further recordings until two of the recordings are within 10 beats/min. 2 Measuring Temperature 3.5.1 3.5.2 3.5.3 Explain the procedure to the participant. Check correct equipment, (tympanic thermometer) depending on study protocol requirements. If the reading is lower than 35.5̊C or higher than 37.5̊C, repeat the procedure after 5 minutes to confirm. 4. RELEVANT DOCUMENTS AND REFERENCES 1. https://www.nice.org.uk/guidance/ng136/chapter/Recommendations#measuring-blood-pressure 2. https://www.bhf.org.uk/heart-health/tests/checking-your-pulse Page 3 of 3