Diaphragm Pacing System

The benefits of DPS, as compared to being on a ventilator, include:

• Increased quality of life
• Decreased morbidity, secretions, and pulmonary infections
• Decreased lifetime costs, since a person only needs one ventilator instead of two

The risks and/or side effects of DPS surgery include:

• Pain and spasm at the surgical site
• Mild nausea after the anesthesia
• Damage to internal organ (less than one in 5,000)
• The expected risks with any general anesthesia

Note that not all risks and side effects can be predicted. Read more about related risks and benefits.

Initial assessment and screening

Medical tests required for DPS treatment include:

• Physician and surgeon evaluation for eligibility for treatment
• Chest X-ray
• Blood tests for lab work
• EKG to check heart function

Eligibility criteria

A person may be eligible for DPS treatment if they:

• Are at least 18 years or older and are committed to DPS treatment.
• Have a cervical spinal cord injury and depend on mechanical ventilation.
• Are clinically stable following an acute spinal cord injury.
• Have a committed primary caregiver who can devote several hours a day to operating the system.

Additional eligibility considerations:

• The patient or designated representative and the caregiver will be required to sign a patient and caregiver agreement form.
• Female patients of childbearing age must have a negative pregnancy test.

Ineligibility criteria

A person would be considered ineligible for DPS treatment if they:

• Have any medical conditions that would interfere with the surgery.
• Have active lung disease, heart disease, or brain disease.
• Require supplemental oxygen use.
• Have been hospitalized for or treated for an active infection within the last three months.
• Have a significant chest deformity or scoliosis.
• Are significantly overweight.

Additional ineligibility considerations:

• A female patient is currently pregnant or breastfeeding.
• There is cause to anticipate poor compliance with the treatment plan by the person or their caregiver.
• The person’s physician has a reason why the patient would not be eligible.

A person found eligible for DPS treatment can anticipate surgery.

On surgery day, the patient will be taken to the Piedmont Hospital surgery center and be put to sleep. The surgeon will create four to five dime-size holes in the abdominal region. A laparoscope will be inserted, so that the diaphragm muscle can be seen. The electrodes are attached to the diaphragm muscle and wires are tunneled under the skin to exit at the lateral chest. The wires will be tunneled under and out of the skin, through the chest, and attached to the connector pins that will secure the wires. The connector will snap into the bandage connector port.

The connector should lie flat against the skin. Check the wires. Make sure that they are properly positioned within the connector. Call the outpatient call center if you see a change in the appearance of the connector.

• Turn off the stimulator, remove the stimulator cable, and place patient back on the ventilator.
• Call a medical professional.
• Do not pull or cut the wires.
• Use extreme caution when shaving skin area around wire site.
• Do not manipulate the metal pins in the connector.

Skin care

A skin bandage with connection port or clip will be provided. The bandage has a connection port that will anchor the orange exit connector.

• Keep the skin at the exit sites clean and dry.
• Do not scratch skin at exit sites or try to remove glue residue.
• Clean the exit sites with alcohol or chlorascrub swab, allow it to dry, place a clean gauze dressing over the exit site. Be sure to cover all the wires with the gauze.
• Change the dressings every three days, or more often if the dressing becomes wet or otherwise soiled.
• A beige skin bandage with connection port (clip) will be placed on chest near nipple line or bra line; observe pins.
• The respiratory therapist will check the view of stimulator cable attached to orange exit connector and cable connection.
• Clean 4×4 gauze pad, taped down on three sides of pad, bottom section of pad untapped for accessible connection to stimulator cable. Cover all wires with gauze pad.
• Do not place tape on beige skin clip bandage.
• Caught tape should be trimmed around edge of the tape bandage instead of tearing the tape off causing disruption of clip bandage.

Cable connection to the stimulator

The stimulator cable will connect the exit site connector (wires) to the stimulator.

• Do not cut, kink, or pull the cable.
• Do not manipulate the metal pins in the end pieces of the cable.
• Keep extra cables in a dry, secure location.
• When in use, the cable should fit securely into the exit site connector and the stimulator.
• The length of the cable should be long enough to provide comfort and allow range of motion without pulling on the exit site connector.
• Notify a medical professional if the cable gets cut, kinked, or falls in water, or in the event of a loose connection to the exit site connector or stimulator.

The stimulator (pacing device)

The cable should be securely inserted into the exit site connector and the top of the stimulator.

• To turn on stimulator: Press down both buttons on the front of the stimulator at the same time
• To turn off stimulator: Press down both buttons on the front of the stimulator at the same time.
• When in use, keep the equipment close to the patient’s body to avoid pulling on the cable and wires. The stimulator can be placed in a pocket of the patient’s clothing, a fanny pack, or a table or any other convenient location.

Additional guidelines

• Do not drop, hit, or throw stimulator.
• Do not immerse in water.
• Do not attempt to open the box.
• Do not expose to long periods of heat or cold.

Notify the outpatient call center if any of the above happens.

Cleaning the stimulator and cable

• The stimulator may be cleaned with disinfectant such as a solution of ¼ teaspoon of household bleach (3-6 percent bleach) added to 1 pint of water.
  • Rubbing alcohol may be used in place of bleach. Household cleaners such as glass or multi-surface spray cleaners are adequate.
  • Do not use these cleaners on parts that will contact the skin.
• Cables may be cleaned with a mild antibacterial hand soap solution.

Stimulator alarms and battery

The stimulator will set off its alarm if it detects a problem with itself, the wires, or the connections. If the cable or wires become loose or disconnected, a beeping sound will go off until the cable or wire is reconnected.

• A 10-second beep will alarm when the stimulator switches to the internal backup battery. The 10-second alarm repeats once every hour.
• A 20-second beep will alarm when the internal backup battery is low. The 20-second alarm repeats once every minute.
• If the stimulator displays “low battery” or “replace batt,” then replace the battery immediately.
• Battery replacement guidelines:
  • The stimulator must be turned off before replacing the battery.
  • Use only special size C Lithium batteries. Do not use a standard alkaline battery in the stimulator.
  • The battery should be changed every 500 hours (3 weeks of full-time pacing).
  • To change the battery, remove the battery cover located on the back bottom of the stimulator. Use a flat blade screwdriver to remove the battery cover located on the back bottom of the stimulator.
  • Remove old battery and replace with new.
  • Replace the battery cover and secure with mounting screws.
  • Dispose of depleted batteries according to local regulations.