Diaphragmatic Pacemaker in Tetraplegic Patients With Spinal Cord Injuries

University of Sao Paulo

Status: Completed

Conditions: Spinal Cord Injury; Diaphragmatic Paralysis; Respiratory Paralysis

Treatments: Device: NeuRx RA/4 diaphragmatic pacemaker

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01385384

NeuRx-055110

Details and patient eligibility

About

Permanent dependency of breathing apparatus due to spinal cord injury is traditionally treated with different types of mechanical ventilation. However, the electric ventilation became a possibility through their most current versions, such as diaphragmatic pacemakers.

Diaphragmatic pacemakers rhythmically stimulates the diaphragm to replace the functions of the respiratory center that doesn't works well or is inaccessible. However, this modality has the prerequisite that the phrenic nerve and diaphragm muscle are normal. The reason for the development of diaphragmatic pacemaker freeing the patient from the ventilator.

By using the mechanical energy of the diaphragm of the patient, the patient may come not need the ventilator tubing, tracheostomy, and with the help of their caregivers, the inconvenient mechanical ventilators.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years old or more
• Cervical spinal cord injuries patients under mechanical ventilation
• Clinically stable after spinal cord injury
• Clinical acceptable bilateral phrenic nerve function demonstrated with electromyography and neural conduction time
• Fluoroscopic visible diaphragmatic movements under stimulation
• Hemodynamically stable
• No co-morbidities that can interfere with pacemaker implantation or function
• Pregnancy negative test for women
• Patient or legal representative informed consent

Exclusion criteria

• Active pulmonary disease
• Active cardiovascular disease
• Active cerebral disease
• Hemodynamic instability or low oxygen levels in ambient air
• Hospitalization for infection in the last 3 months
• Significant scoliosis or chest disease
• Obesity
• Poor compliance to the protocol from the patient or the caregiver

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

NeuRx

Other group

Treatment:

Device: NeuRx RA/4 diaphragmatic pacemaker