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Diaphragmatic Pacemaker in Tetraplegic Patients With Spinal Cord Injuries

This study has been completed.
Sponsor:
Collaborator:
Synapse Biomedical
Information provided by (Responsible Party):
Miguel L. Tedde, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01385384
First received: June 23, 2011
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Respiratory Paralysis
Diaphragmatic Paralysis
Spinal Cord Injury
 Device: NeuRx RA/4 diaphragmatic pacemaker

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the NeuRx RA/4 Diaphragmatic Pacemaker in Tetraplegic Patients With Spinal Cord Injuries in Ventilator Support

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Volume comparison of the basal with the tidal volume obtained with the NeuRx RA/4 pacemaker in patients with diaphragmatic paralysis [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    The ability of the NeuRx RA / 4 to obtain clinically acceptable tidal volume during a period of 4 continuous hours will be evaluated by spirometry. Clinically acceptable volume is defined as a volume in excess of 15% above the basal metabolic requirements of the particular patient. For a male patient, the flow volume to meet the basal metabolic requirement is set at 7 ml/kg body weight, while for a female patient, it is defined in 6ml/Kg body weight.


Secondary Outcome Measures:
  • Functional rehabilitation by measure of total usage time, both day and night [ Time Frame: One year ] [ Designated as safety issue: No ]
    Using spreadsheets to patients and caregivers, will collect information related to the use of the device, such as total usage time, the preference to use it both day and night instead of a mechanical ventilator, or to use it partial time to perform any activity or acquire independence that would otherwise be difficult with mechanical ventilation.


Enrollment: 5
Study Start Date: June 2011
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
NeuRx 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01385384

Locations
Brazil
Heart Institute (InCor) Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Sao Paulo, SP, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Sao Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo
Synapse Biomedical
Investigators
Study Director: Fabio B Jatene, MD, PhD Thoracic Surgery Department, Heart Institute (InCor) do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Study Chair: Manuel J Teixeira, MD, PhD Neurosurgery Department, Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Principal Investigator: Miguel L Tedde, MD, PhD Thoracic Surgery Department, Heart Institute (InCor) do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
  More Information

Publications:

Responsible Party: Miguel L. Tedde, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01385384     History of Changes
Other Study ID Numbers: NeuRx-055110
Study First Received: June 23, 2011
Last Updated: March 18, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Respiratory Paralysis
Spinal Cord Injuries
Paralysis
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Neurologic Manifestations
 Nervous System Diseases
Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on June 17, 2013