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| Name | Class |
|---|---|
| Synapse Biomedical | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NeuRx | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Functional rehabilitation by measure of total usage time, both day and night | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Institute (InCor) Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo | São Paulo | São Paulo | Brazil | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23184201 | Result | 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. | |
| 23147048 |
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| ID | Term |
|---|---|
| D012133 | Respiratory Paralysis |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010243 | Paralysis |
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| One year |
| Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo |
| São Paulo |
| São Paulo |
| Brazil |
| 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. |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |