Diaphragmatic Pacemaker in Tetraplegic Patients With Spinal Cord Injuries

NCT01385384 | Completed DMC

• 1 other identifier: NeuRx-055110
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Volume comparison of the basal with the tidal volume obtained with the NeuRx RA/4 pacemaker in patients with diaphragmatic paralysis

  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.

  One year

Secondary Outcomes (1)

• Functional rehabilitation by measure of total usage time, both day and night

  One year

Study Arms (1)

NeuRx

OTHER

Device: NeuRx RA/4 diaphragmatic pacemaker

Interventions

NeuRx RA/4 diaphragmatic pacemaker 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.

NeuRx

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Synapse Biomedical: collaborator

Study Sites (2)

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

São Paulo, São Paulo, Brazil

Location

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

São Paulo, São Paulo, Brazil

Location

Related Publications (2)

• 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.

  PMID: 23184201 RESULT

• 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.

  PMID: 23147048 RESULT

MeSH Terms

Conditions

Respiratory Paralysis; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• 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 DIRECTOR

• Manuel J Teixeira, MD, PhD

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

  STUDY CHAIR

• Miguel L Tedde, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: June 30, 2011
• Study Start: June 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 19, 2013

Record last verified: 2013-03

Locations

BR (2)