Diaphragmatic Pacemaker in Tetraplegic Patients With Spinal Cord Injuries

Not Applicable

Completed

• Conditions: Respiratory Paralysis; Diaphragmatic Paralysis; Spinal Cord Injury
• Interventions: Device: NeuRx RA/4 diaphragmatic pacemaker

• Registration Number: NCT01385384
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-23
• Study First Submitted QC: 2011-06-28
• Study First Posted: 2011-06-30
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-18
• Last Update Posted: 2013-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NeuRx	NeuRx RA/4 diaphragmatic pacemaker	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo; 🇧🇷 Sao Paulo, Brazil

Heart Institute (InCor) Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo; 🇧🇷 Sao Paulo, SP, Brazil