Diaphragmatic Pacemaker in Tetraplegic Patients With Spinal Cord Injuries

Summary

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.

Conditions

• Respiratory Paralysis
• Diaphragmatic Paralysis
• Spinal Cord Injury

Interventions

DEVICE

NeuRx RA/4 diaphragmatic pacemaker

Patients will be implanted with 4 intramuscular electrodes, 2 in each hemi-diaphragm, using laparoscopic techniques. The abdominal cavity is inflated with CO2 and 4 ports are inserted: one for optics, 2 for a probe containing a temporary electrode for mapping the diaphragm and the electrode insertion tool, and a smaller one for the output wires of the electrodes of the abdominal cavity. The intra-abdominal pressure variation during the stimulation test (mapping) will be measured externally by one of the ports. Sites that provide the optimal response (greater region and magnitude) are noted. Once the optimal site for electrode placement is identified two intramuscular electrodes are deployed in each hemi-diaphragm. The guide wires will come out of the peritoneum through the port placed in the xiphoid region. An additional electrode is placed subcutaneously in the upper abdomen. The instruments and ports are then removed and the incision sites closed.

Sponsors & Collaborators

• Synapse Biomedical

  collaborator INDUSTRY

• University of Sao Paulo

  lead OTHER

Principal Investigators

• Fabio B Jatene, MD, PhD · Thoracic Surgery Department, Heart Institute (InCor) do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

• Manuel J Teixeira, MD, PhD · Neurosurgery Department, Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

• Miguel L Tedde, MD, PhD · Thoracic Surgery Department, Heart Institute (InCor) do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-06-30

Primary Completion

2012-11-30

Completion

2012-12-31

Countries

• Brazil

Study Locations