Clinical trial NCT01385384: Diaphragmatic Pacemaker in Tetraplegic Patients With Spinal Cord Injuries
Official title: Evaluation of the NeuRx RA/4 Diaphragmatic Pacemaker in Tetraplegic Patients With Spinal Cord Injuries in Ventilator Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Paralysis
Diaphragmatic Paralysis
Spinal Cord Injury
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Synapse Biomedical
First posted: 2011-06-30
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Volume comparison of the basal with the tidal volume obtained with the NeuRx RA/4 pacemaker in patients with diaphragmatic paralysis
timeFrame: One year
Secondary outcomes:
measure: Functional rehabilitation by measure of total usage time, both day and night
timeFrame: One year
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Heart Institute (InCor) Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Study officials:
affiliation: Thoracic Surgery Department, Heart Institute (InCor) do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
name: Fabio B Jatene, MD, PhD
role: STUDY_DIRECTOR
affiliation: Neurosurgery Department, Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
name: Manuel J Teixeira, MD, PhD
role: STUDY_CHAIR
affiliation: Thoracic Surgery Department, Heart Institute (InCor) do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
name: Miguel L Tedde, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.