Diaphragmatic Pacemaker in Tetraplegic Patients With Spinal Cord Injuries

NCT ID: NCT01385384

Last Updated: 2013-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-12-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NeuRx

Group Type: OTHER

NeuRx RA/4 diaphragmatic pacemaker

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synapse Biomedical

INDUSTRY

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Miguel L. Tedde

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fabio B Jatene, MD, PhD

Role: STUDY_DIRECTOR

Thoracic Surgery Department, Heart Institute (InCor) do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

Manuel J Teixeira, MD, PhD

Role: STUDY_CHAIR

Neurosurgery Department, Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

Miguel L Tedde, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Thoracic Surgery Department, Heart Institute (InCor) do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

Locations

Heart Institute (InCor) Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, São Paulo, Brazil

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

References

Tedde ML, Vasconcelos Filho P, Hajjar LA, de Almeida JP, Flora GF, Okumura EM, Osawa EA, Fukushima JT, Teixeira MJ, Galas FR, Jatene FB, Auler JO Jr. Diaphragmatic pacing stimulation in spinal cord injury: anesthetic and perioperative management. Clinics (Sao Paulo). 2012 Nov;67(11):1265-9. doi: 10.6061/clinics/2012(11)07.

Reference Type: RESULT

PMID: 23184201 (View on PubMed)

Tedde ML, Onders RP, Teixeira MJ, Lage SG, Ballester G, Brotto MW, Okumura EM, Jatene FB. Electric ventilation: indications for and technical aspects of diaphragm pacing stimulation surgical implantation. J Bras Pneumol. 2012 Sep-Oct;38(5):566-72. doi: 10.1590/s1806-37132012000500005. English, Portuguese.

Reference Type: RESULT

PMID: 23147048 (View on PubMed)

Other Identifiers

NeuRx-055110

Identifier Type: -

Identifier Source: org_study_id