909 ECG

Purpose

To ensure the Principal Investigator (PI) and all research team members assisting with the conduct of clinical research at the Ohio University Heritage College of Osteopathic Medicine’s Clinical and Translational Research Unit (CTRU) are informed about their obligations and responsibilities as they pertain to Good Clinical Practices (GCP), the investigational plan, applicable regulations, and institutional policies.

This Standard Operating Procedure (SOP) gives general guidance to study personnel on how to obtain a participant electrocardiogram. All clinical staff working in the Clinical & Translational Research Unit (CTRU) will use the same procedure to obtain a standard 12 lead ECG reading as specified in the trial protocol, to ensure continuity and consistency in recordings.

Responsibilities

The CTRU is responsible for developing, implementing, and maintaining SOPs. Creating new or revising an existing SOP is determined by changes to federal regulation, guidelines, institutional policies, or procedures. All applicable documents will be provided to departments and research teams conducting human subject research.

Definitions

12-Lead ECG: A non-invasive procedure that is used to ascertain information about the electrophysiology of the heart.

Procedures

1. Principal Investigator (PI) responsibilities

• The Principal Investigator (PI) is responsible for ensuring the standard 12 lead ECG is recorded according to protocol.

The PI or delegated study staff will refer to the protocol to ensure specific requirements for obtaining a 12 lead ECG reading are identified. This may include the use of a specific machine solely for individual study use. In this case, the sponsor will dictate the ECG procedure. If nothing is specified in the protocol, then the PI or delegated person should follow the procedure below.

2. Lead Placement

• V1: In the 4th intercostal space to the right of the sternum
• V2: In the 4th intercostal space to the left of the sternum
• V3: In the interval between lead 2 and 4
• V4: In the 5th intercostal space on the mid-clavicular line
• V5: Straight across from lead 4 on the anterior axillary line
• V6: Straight across from lead 4 on the mid-axillary line
• RA: On the right forearm or wrist, avoid thick muscle
• LA: In the same location where RA was placed, but on the left forearm or wrist
• RL: On the right leg, lateral calf muscle
• LL: In the same location where RA was placed, but on the left leg

3. ECG Procedure

• Identify the subject.
• Assemble all equipment required (ECG machine, leads, paper, electrodes) and ensure it is clean and appears to be in good working order.
• Ask the participant to remove any clothing that may restrict access to the upper body or limbs and ask them lay down in a comfortable position.
• Switch on the ECG machine and wait for the self-test to be performed.
• Enter the participant’s details and study specific data into the ECG machine as outlined in the study protocol.
• Attach the ECG electrodes to the chest and limbs; if necessary, the skin should be prepared by cleaning with an alcohol wipe or shaving to ensure good contact.
• Attach the ECG cables to the electrodes in the correct order. Tab electrodes are to be used. The electrodes should be affixed to the patient’s skin and the limb leads then connected.
• Instruct the participant to relax and remain as still as possible for the ECG recording.
• Wait 10 seconds and observe the tracing displayed in the ECG display screen to ensure good electrode contact identified by a good tracing. The screen should also be observed for any error messages that may be displayed.
• Review the recording and if it is satisfactory remove the ECG electrodes from the participant and ask them to get dressed.
• Ask the appropriate person to review the recording if the operator is not qualified to do so themselves. The qualified staff must sign and date the ECG.
• Document that the ECG recording has been performed on the relevant study source data, the case report form and in the participant’s medical notes.
• Dispose of the used electrodes in a waste bin and place razors, if used, into a sharps container.
• Calibration will be performed semi-annually. For study specific ECG machines, it is the responsibility of the PI to ensure this is performed semi-annually.
• The ECG cables, screen and surfaces will be cleaned with a disinfecting wipe, spray or per manufacturer’s recommendations after each use.

References: Fundamentals of Nursing, Potter and Perry 7th Edition

Attachments: None

Appendices: None

Approver: CTRU Medical Director