Diaphragmatic Pacemaker in Tetraplegic Patients With Spinal Cord Injuries

Sponsor

University of Sao Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT01385384

Collaborator

Synapse Biomedical (Industry)

Enrollment

Locations

Arm

Duration (Months)

2.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Paralysis Diaphragmatic Paralysis Spinal Cord Injury	Device: NeuRx RA/4 diaphragmatic pacemaker	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.

Arm

Intervention/Treatment

Other: 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.

Outcome Measures

Primary Outcome Measures

Volume comparison of the basal with the tidal volume obtained with the NeuRx RA/4 pacemaker in patients with diaphragmatic paralysis [One year]
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 [One year]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Heart Institute (InCor) Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo	Sao Paulo	SP	Brazil
2	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