Peripherally Inserted Central Catheter & Midline Placement with ECG Confirmation of Tip Placement

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Title/Description: Peripherally Inserted Central Catheter & Midline Placement with ECG Confirmation of Tip Placement Department: Patient Care Services Personnel: Nursing Services Effective Date: April 2014 Revised: 01/16. PURPOSE: To facilitate the insertion of a peripherally inserted central catheter (PICC) in patients who require reliable venous accesses for typically 5 days or more of infusion therapy of vesicants, and/or solutions/medications with the osmolarity >500 mosm per liter or ph < 5 or > 9. If unable to successfully thread tip to SVC (Superior Vena Cava), the placement of midline catheter (MLC) is appropriate for patients with poor venous accesses requiring infusion therapy of non-vesicants and isotonic solutions. PROCEDURE: Precautions and Key Points: 1. ECG TCS (Electrocardiogram Tip Confirmation System) should be used or a chest X-Ray confirmation is required for tip placement verification before the PICC can be used. Once the catheter is confirmed in SVC, the provider or RN interpreting the ECG or X-ray may enter electronic orders for floor nurses to use and maintain the catheter. 2. The Sherlock II Tip Location System (TLS) detector quickly locates the position of specially designed, magnet-tipped PICCs during initial placement. 3. Catheter stylets provide internal reinforcement to aid in catheter placement. When used with the Sherlock Tip Positioning System (TPS), the Sherlock TPS stylet also provides the placer real-time feedback on the catheter tip location and orientation through the use of passive magnets and cardiac electrical single detection. When used with the Sapiens ECG TCS, the Sherlock stylet also provides the place real-time feedback on catheter tip location through the use of cardiac electrical signal detection. 4. The Sapiens Tip Confirmation System is indicated for guidance and positioning of PICCs. The Sapiens TCS provides real-time catheter tip location information by using the patient s cardiac electrical activity. Sapiens TCS is indicated for use as an alternative method to chest x-ray and fluoroscopy for PICC tip placement confirmation in adult patients. Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial fibrillation, atrial flutter, severe tachycardia, and pacemaker driven rhythm. In such patients, who are easily identifiable prior to PICC insertion, the use of an additional method is required to confirm catheter tip location. Definitions:

1. PICC - central vascular access device (CVAD) inserted peripherally from veins located at the upper extremities such as the basilic, brachial, cephalic, and jugular, with the tip terminating within the superior vena cava, preferably in the lower 1/3 or in the area of the atriocaval junction. 2. MLC - peripheral VAD inserted from veins located at the upper extremities with the tip terminating proximal to the axilla. This type of VAD is ONLY appropriate for the infusion of blood products, IV fluids, and iso-osmotic medications. This device should be discontinued or replaced with a true central access device within approximately 29 days. Qualifications for Insertion: 1. PICC/MLC placement may be done by a Registered Nurse (RN) who has completed an accredited didactic training course, and been validated by a preceptor with at least five successful placements. 2. The Registered Nurse will undergo an annual evaluation by qualified clinician. 3. A licensed physician or registered nurse who has demonstrated competency and have completed the online education course on the Sapiens TCS may insert the Sherlock II TLS Sapiens TCS PICC. 4. A physician s order is needed for PICC insertion 5. Sapiens TCS offers tip confirmation when proper procedure is followed. Procedure: 1. Prior to beginning the procedure, examine the package carefully before opening to confirm integrity and ensure expiration date has not been passed. Do not use expired kits or packages that appear damaged. 2. Prepare electronic systems following instructions provided 3. Position Patient and Perform Ultrasound Pre-scan a) Position the arm abducted at 90 angle for catheter placement. b) Apply tourniquet above the anticipated insertion site. c) Perform ultrasound pre-scan. d) Select a vein based on patient assessment and pre-scan. e) Note the maximum vessel depth at catheter insertion site as displayed on ultrasound. f) Accurately mark planned insertion site on patient s arm. g) Release tourniquet. 4. Determine External Measurement a) For central placement, the recommended tip location is the lower 1/3 of the SVC, close to the cavoatrial junction. b) When possible, ensure patient has both shoulders on the bed without rotation during measurement procedure. c) To prevent inaccuracy, measure directly on patient s skin avoiding clothing, bedding, dressings, ECG electrodes and other medical or personal equipment. d) NOTE: External measurements can never exactly duplicate the internal venous anatomy. e) Measure path from the planned insertion site using the following external landmarks: 1) Insertion site to axillary crease 2) Axillary crease to right clavicular head. Measure to the RIGHT clavicular head for both left and right-sided placements. 3) Right clavicular head to right sternal border of the third intercostals space.

4) NOTE: The first intercostal space may be difficult to palpate due to its proximity to the clavicle. 5) In cases where target vessel depth is significant, maximum vessel depth may be added to measured path to determine final external measurement. 6) Other measurement techniques may be used depending on PICC RN clinical judgment. 5. Prepare Sensor a) Attach fin assembly to Sensor and place Sensor in holder. b) Position Sensor on patient s chest with the top of Sensor above the sternal notch and centered on the sternum. c) Prepare and attach external ECG electrodes to all three lead wires. Ensure electrode locations are oil-free and completely dry. d) Remove backing and press firmly onto skin at the specified locations: 1) Place BLACK electrode lead wire on patient s left shoulder 2) Place RED electrode lead wire on lower left side inferior to the umbilicus and laterally along the mid-axillary line. CAUTION: Placement of red lead wire outside of this region may result in reduced ECG performance. 3) Place GREEN electrode lead wire on patient s lower right side, inferior to the umbilicus and laterally along the mid-axillary line. e) WARNING: Place skin electrode lead wires carefully at locations indicated above and ensure good skin-electrode contact. Failure to do so may cause unstable ECG waveforms. In such a case, use chest radiograph or fluoroscopy to confirm catheter tip location, as indicated by guidelines and clinical judgment. 6. Evaluate baseline ECG: a) In Sherlock II mode, calibrate magnetic tracking system b) Turn on Sapiens TCS and note external waveform. c) Verify that P-wave is present, identifiable and consistent on the main screen. d) If no persistent or regular P-wave is identified, continue with procedure utilizing magnetic tracking and external measurements followed by tip confirmation via chest radiograph or fluoroscopy. e) Enter patient identification information. f) Adjust ECG scale as needed to ensure that entire ECG waveforms are visible in the ECG window throughout the insertion procedure. 7. Prepare insertion site and sterile field. a) Apply tourniquet above intended insertion site to distend vessel. b) Wash hands per protocol. c) Don hair cover, face mask, and sterile gloves. d) Remove under drape and (tinted) ChoraPrep from tray. e) Place under drape beneath arm and prep skin site per correlating guidelines. f) Remove and don sterile gown and sterile gloves. g) Set up sterile field and maximum barrier drape according to catheter instructions for use. Note: Do not re-prep the patient after applying maximum barrier drape. h) Cover the probe and cable with the sterile probe cover and place on sterile field. i) Cover the remote control with the sterile probe cover and place on sterile field. 8. Prepare catheter

a) Pre-flush all lumens of the catheter with sterile normal saline to wet hydrophilic stylet. 9. Access Vein a) Utilizing ultrasound, locate vessel. b) Access vein and remove needle. c) Secure and remove guidewire. 10. Trim Catheter to Length a) Trim catheter to length 1) Measure the distance from the zero mark to the predetermined catheter external measurement 2) To ensure adequate catheter length to reach maximum p-wave amplitude, it is recommended that 5 cm be added to this measurement. Catheter length should be based on clinician measurement technique and experience 3) Loosen the T-lock connector/stylet assembly 4) Retract the entire T-lock connector/stylet assembly as one unit until the stylet is well behind the catheter cut location. Do not entirely remove the stylet from the catheter 5) Using a sterile scalpel or scissors, carefully cut the catheter 6) Inspect cut surface to ensure there is no loose material 7) Re-advance the T-lock connector/stylet assembly locking the connector to the catheter hub. Ensure stylet tip is intact 8) Gently retract the stylet through the locked T-lock connector until the stylet tip is contained inside the catheter 9) Prior to insertion, ensure that the stylet tip is contained inside and within the catheter but not more than 1 cm from the trimmed end of the catheter 11. Catheter Insertion a) Attach catheter stylet to fin assembly. 1) Palpate the Fin Assembly through the drape. 2) Form and pinch the drape around the Fin Assembly to conform the drape to the Fin Assembly. 3) Place the stylet connector on the bottom end of the Fin Assembly and slide connector forward until it is fully seated. 4) Lay catheter on sterile field. b) Uncoil catheter stylet lead. c) In Sherlock mode, calibrate magnetic tracking system immediately prior to catheter insertion. d) Perform microintroduction e) Remove guidewire and dilator from microintroducer. f) Insert catheter until magnetic tracking icon appears or approximately 10 cm and STOP inserting catheter. g) Attach saline-filled syringe. Flush catheter with saline and wait for intravascular waveform to stabilize. h) Verify that P-wave on the intravascular ECG waveform is present, identifiable and consistent on the main screen of the Sapiens TCS. 12. Catheter Tip Guidance and Positioning: a) Follow Sherlock II TLS Instructions for Use for magnetic navigation.

b) Insert catheter until the magnetic navigation shows stylet icon moving consistently downward. c) Continue to slowly advance catheter until the catheter is inserted to the external measurement determined prior to insertion. d) Press the FREEZE button on Sapiens TCS. This will save the current waveform on the right side reference screen for later comparison. e) SLOWLY adjust catheter tip position until maximum P-wave amplitude is reached. Compare main screen waveform to reference screen waveform while closely monitoring for negative P-wave deflection. f) Warning: Do not rely on ECG signal detection for catheter tip positioning when there are no observable changes in the P-wave. In this case, rely on magnetic navigation and external measurement for tip positioning and use chest radiograph or fluoroscopy to confirm catheter tip location as indicated by institutional guidelines and clinical judgment. g) NOTE: The P-wave may continue to increase in amplitude when initial negative deflection is noted. In this case, adjust catheter tip position to maximum P-wave amplitude with no negative deflection. h) Advance or retract catheter from maximum P-wave to place tip in desired location. Note catheter exit site marking and document on Sapiens TCS screen. i) To record waveforms at final catheter tip position, press FREEZE button on Sapiens TCS. Press the print to file button to save image. This will save baseline and final waveforms for documentation in medical record. 13. Procedure Completion: a) Remove stylet / T-Lock assembly 1) Hold the front portion of the Fin Assembly to stabilize the Fin Assembly and Sensor. Disconnect the stylet lead from the Fin Assembly by pulling the connector toward the bottom of the Sensor. 2) Follow catheter Instructions for Use to remove the Stylet/T-Lock assembly from the catheter. b) Aspirate and flush PICC. Follow catheter Instructions for Use. c) Secure catheter with Statlock or (sutures if needed) and confirm that exit site marking is accurate. d) Locate and secure remote control. e) Remove drapes, external electrodes, and sensor. 1) Remove and discard drapes in proper waster container. 2) Remove external ECG electrodes and Sensor from patient. 3) Loosen the cinch ring on the sensor holder and take out the Sensor with Fin Assembly. 4) Remove fin assembly. 5) Remove remote control from remote control holder. 6) Dispose of sensor holder, remote control holder and fin assembly in proper waste container. 7) CAUTION: Ensure remote control is not discarded. CONFIRMATION OF TIP LOCATION: 1. Confirmation is required for tip location of PICCs placed.

2. No confirmation is needed for Midlines placed. 3. Tip location may be confirmed by ECG TCS, STAT (portable) chest x-ray, or fluoroscopy. ECG confirmation: 1. The Sapiens TCS provides real-time catheter tip location information by using the patient s cardiac electrical activity. The PICC may be used immediately after the procedure when the practitioner determines this method has been successful. Proper documentation of P-wave activity will be placed in the chart. 2. Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial fibrillation, atrial flutter, severe tachycardia, and pacemaker driven rhythm. In such patients, who are easily identifiable prior to PICC insertion, the use of an additional method will be used to confirm catheter tip location.