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10. Confirm proper tip placement with fluoroscopy. The distal "venous" tip should be positioned at the junction of the superior vena cava and right atrium or into the
right atrium for optimal blood flow.
WARNING: Failure to verify catheter placement with fluoroscopy may result in serious trauma or fatal complications.
11. Secure and dress the catheter as noted in "Securement and Dressing"
INSERTION TECHNIQUE (2) - COMMON STEPS PERCUTANEOUS ENTRY INTO RIGHT INTERNAL JUGULAR VEIN
VENOUS ACCESS AND GUIDE WIRE INSERTION
1.
K-DOQI Guidelines recommend the use of ultrasound guidance.
NOTE: Mini access ("micropuncture") is recommended. Follow manufacturers guidelines for proper insertion technique.
Insert the introducer needle with an attached syringe and advance it into the target vein, in the direction of blood flow. Aspirate gently as the insertion is made.
Aspirate a small amount of blood to ensure the needle is correctly positioned in the vein.
PRECAUTION: If arterial blood is aspirated, remove the needle and apply immediate pressure to the site for at least 15 minutes. Ensure that the bleeding has
stopped and that no hematoma has developed before attempting to cannulate the vein again.
2.
When the vein has been entered, remove the syringe leaving the needle in place and place thumb over the hub of the needle to minimize blood loss and / or air
embolism.
3.
Insert the distal end of the marker guide wire into the needle hub (or mini access introducer hub) and pass it into the vasculature.
PRECAUTION: If using the "J" tipped wire provided, draw the tip of the wire back into the straightener so that only the tip of the wire is exposed.
4.
Advance the guide wire with forward motion until the tip resides in the junction of the superior vena cava and right atrium.
WARNING: Cardiac arrhythmias may result if the guide wire is allowed to pass into the right atrium.
CAUTION: Do not advance the guide wire or catheter if unusual resistance is encountered.
CAUTION: Do not insert or withdraw the guide wire forcibly from any component. The wire may break or unravel. If the guide wire becomes damaged and must
be removed while the needle (or sheath introducer) is inserted, the guide wire and needle should be removed together.
PRECAUTION: The length of the guide wire inserted is determined by the size of the patient and the anatomical site used.
PRECAUTION: Always confirm proper guide wire position using fluoroscopy. Depth markings on the wire will help determine indwelling depth.
5.
Remove the needle (or mini access introducer), leaving the guide wire in place. The guide wire should be held securely during the procedure. The introducer
needle must be removed first.
CATHETER PREPARATION AND SUBCUTANEOUS TRACT DILATION
1.
The ProGuide catheter is packaged with a guide wire stiffening stylet positioned in the venous lumen to facilitate placement using the over-the-wire technique.
2.
Withdraw the stiffening stylet approximately 2-3 cm and confirm that the stylet tip is not visible at the end of the catheter.
3.
Irrigate the arterial lumen and stiffening stylet with heparinized saline and clamp the red arterial extension prior to catheter insertion.
WARNING: The heparin solution must be aspirated out of both lumens immediately prior to using the catheter to prevent systemic heparinization of the patient.
WARNING: To minimize the risk of air embolism, keep the catheter clamped at all times when not in use or when attached to a syringe, IV tubing, or bloodlines.
WARNING: Patients requiring ventilator support are at increased risk of pneumothorax during subclavian vein cannulation.
CAUTION: Do not clamp the dual lumen portion of the catheter body. Clamp only the clear extension tubing.
PRECAUTION: Only clamp the catheter with the in-line tubing clamps provided.
4.
Determine the catheter exit site on the chest wall, approximately 8-10 cm below the clavicle that is below and parallel to the venous puncture site.
PRECAUTION: A tunnel with a wide, gentle arc lessens the risk of catheter kinking. The distance of the tunnel should be short enough to keep the bifurcated
junction from entering the exit site, yet long enough to keep the cuff 2-3 cm (minimum) from the skin opening site.
5.
Make a small incision at the desired exit site of the tunneled catheter on the chest wall. The incision should be wide enough to accommodate the cuff,
approximately 1 cm.
6.
Use blunt dissection to create the subcutaneous tunnel opening at the catheter exit site for the white tissue ingrowth cuff, midway between the skin exit site and
the venous entry site, approximately 2-3 cm minimum from the catheter exit site.
WARNING: Do not over-expand the subcutaneous tissue during tunneling. Over-expansion may delay or prevent cuff in-growth.
7.
Make a second incision above and parallel to the first, at the venous insertion site. Enlarge the cutaneous site with a scalpel and create a small pocket with blunt
dissection to accommodate the small remaining catheter loop ("knuckle") of the catheter.
8.
Attach the tunneler to the catheter's venous lumen. Slide the tip of the catheter over the tri-ball connection until it rests adjacent to the sheath stop.
9.
Slide the tunneler sheath over the catheter making certain that the sleeve covers the arterial lumen. This will reduce the drag in the subcutaneous tunnel as the
apposition bump and arterial port pass through the tissue.
10. With the blunt tunneler, gently lead the catheter and tunneler connection into the exit site and create a subcutaneous tunnel from the catheter exit site to
emerge at the venous entry site.
CAUTION: The tunnel should be made with care to avoid damage to surrounding vessels. Avoid tunneling through muscle.
CAUTION: Do not pull or tug the catheter tubing. If resistance is encountered, further blunt dissection may facilitate insertion. The catheter should not be forced
through the tunnel.
11. After tunneling the catheter, the tunneler can be removed by sliding the tunneler sheath away from the catheter and pulling the tunneler from the distal tip of
the catheter.
CAUTION: Avoid damage to the catheter by using a slight twisting motion.
CAUTION: To avoid damage to the catheter tip, keep the tunneler straight and do not pull it out at an angle.
CAUTION: Inspect catheter tip for damage before proceeding with procedure.
12. Remove the stylet label and tighten down the luer lock nut of the stylet to the blue venous luer lock connection.
13. Thread the distal tip of the stylet with the catheter over the proximal tip of the guide wire until the guide wire exits the venous luer connection.
14. While maintaining guide wire position in the vein, advance catheter to the junction of the superior vena cava and right atrium to ensure optimal blood flow.
PRECAUTION: To help minimize catheter kinking, it may be necessary to advance in small steps by grasping the catheter close to the skin.
15. Remove the stylet and guide wire from the venous lumen.
16. Press the small remaining catheter loop ("knuckle") gently into the subcutaneous pocket created at the venous entry site.
WARNING: Catheters should be implanted carefully to avoid any sharp or acute angles which could compromise the flow of blood or occlude the opening of the
catheter lumens.
PRECAUTION: For optimal product performance do not insert any portion of the cuff into the vein.
17. Make any adjustments to the catheter insertion depth and tip position under fluoroscopy.
18. Attach syringes to both extensions and open the clamps. Confirm correct placement and catheter function by aspirating blood from both lumens. Flush each
lumen with heparinized saline (priming volume is printed on the extension tubing clamp). Blood should aspirate easily.
PRECAUTION: If either lumen exhibits excessive resistance to blood aspiration, the catheter may need to be rotated or repositioned to obtain adequate blood flow.
PRECAUTION: To maintain patency, a heparin lock must be created in both lumens.
PRECAUTION: It is recommended that the "venous" lumen be oriented cephalad (toward the head).
19. Clamp the extensions immediately after flushing.
20. Remove the syringes and replace with injection caps.
CAUTION: Avoid air embolism by keeping extension tubing clamped at all times when not in use and by aspirating then irrigating the catheter prior to each use.
21. Correctly position the cuff and tunneled portion of the catheter.
22. Confirm proper tip placement with fluoroscopy. The distal "venous" tip should be positioned at the junction of the superior vena cava and right atrium or into the
right atrium for optimal blood flow.
WARNING: Failure to verify catheter placement with fluoroscopy may result in serious trauma or fatal complications.
SECUREMENT AND DRESSING
1.
Suture the pocket created for the small remaining catheter loop ("knuckle") at the venous entry site.
2.
If necessary, suture the catheter exit site.
3.
Suture the catheter to the skin with the suture wing.
WARNING: Do not suture through any part of the catheter. If sutures are used to secure the catheter, make sure they do not occlude or cut the catheter. Catheter
tubing may tear when subjected to excessive force or rough edges.
PRECAUTION: The catheter must be secured / sutured for the entire duration of implantation.
4.
Apply transparent site dressing to catheter exit site and the tunneled insertion site using standard institutional protocol.
WARNING: Do not use sharp instruments near the extension tubing or catheter body.
WARNING: Do not use scissors to remove dressing.
WARNING: Alcohol or alcohol-containing antiseptics may be used to clean the catheter/skin site; however, care should be taken to avoid prolonged or excessive
contact with the solution(s).
WARNING: Acetone and PEG-containing ointments can cause failure of this device and should not be used with polyurethane catheters.
5.
Record the catheter length and catheter lot number on the patient's chart. Note in the chart that Acetone and PEG-containing ointments should not be used with
this device.
SITE CARE
1.
Clean the skin around the catheter.
WARNING: Use of ointments/creams at the wound site is not recommended.
2.
Cover the exit site with occlusive dressing and leave extensions, clamps, and caps exposed for access by dialysis team.
3.
Wound dressings must be kept clean and dry.
CAUTION: Patients must not swim or soak the dressing unless instructed by a physician.
PRECAUTION: If profuse perspiration or accidental wetting compromises adhesion of the dressing, the medical and nursing staff must change the dressing under
sterile conditions.
CATHETER REMOVAL
As with all invasive procedures, the physician will assess the anatomical and physiological needs of the patient to determine the most appropriate catheter removal
technique. The white implantable retention cuff facilitates tissue ingrowth, therefore the catheter must be surgically removed.
WARNING - Only a physician familiar with the appropriate removal techniques should attempt to remove an implanted chronic dialysis catheter.
CAUTION: Always review institutional protocol, potential complications and their treatment, warnings and precautions prior to catheter removal.
CAUTION STATEMENTS REGARDING HEMODIALYSIS TREATMENT
•
Hemodialysis should be performed under a physician's instruction using approved institutional protocol.
WITH AN OVER-THE-WIRE TECHNIQUE
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