Respiratory ParalysisNCT01385384
Diaphragmatic Pacemaker in Tetraplegic Patients With Spinal Cord Injuries
A study testing NeuRx RA/4 diaphragmatic pacemaker in people with Respiratory Paralysis and Diaphragmatic Paralysis, run by University of Sao Paulo at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Paralysis, Diaphragmatic Paralysis, Spinal Cord Injury
- What is being tested?
- NeuRx RA/4 diaphragmatic pacemaker
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesBrazil
- Study dates
- Jun 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- No co-morbidities that can interfere with pacemaker implantation or function
- Pregnancy negative test for women
- Patient or legal representative informed consent
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Heart Institute (InCor) Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo
About this study
Official title: Evaluation of the NeuRx RA/4 Diaphragmatic Pacemaker in Tetraplegic Patients With Spinal Cord Injuries in Ventilator Support
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.
- Being tested
- NeuRx RA/4 diaphragmatic pacemaker
- Medical subject headings
- Respiratory Paralysis, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuRx RA/4 diaphragmatic pacemakerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| NeuRx | Other | Not described Receives: Device: NeuRx RA/4 diaphragmatic pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Secondary outcomes (1)
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory ParalysisStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Synapse Biomedical
- Responsible party
- Principal investigator, Miguel L. Tedde, University of Sao Paulo
- Investigators
- Fabio B Jatene, MD, PhD, Study director, Thoracic Surgery Department, Heart Institute (InCor) do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao PauloManuel J Teixeira, MD, PhD, Study chair, Neurosurgery Department, Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao PauloMiguel L Tedde, MD, PhD, Principal investigator, Thoracic Surgery Department, Heart Institute (InCor) do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385384
- Sponsor's protocol ID
- NeuRx-055110
- Status last verified
- Mar 2013
- First submitted
- 23 Jun 2011
- Last updated
- 19 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23184201Tedde 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.
PubMed 23147048
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the NeuRx RA/4 Diaphragmatic Pacemaker in Tetraplegic Patients With Spinal Cord Injuries in Ventilator Support
- ClinicalTrials.gov ID
- NCT01385384
- Acronym / sponsor ID
- NeuRx-055110
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Synapse Biomedical
- Study start
- Jun 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NeuRx | Other | Device: NeuRx RA/4 diaphragmatic pacemaker |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuRx RA/4 diaphragmatic pacemakerPatients 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. | Device | NeuRx |
Primary outcome
Volume comparison of the basal with the tidal volume obtained with the NeuRx RA/4 pacemaker in patients with diaphragmatic paralysis
Time frame: 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.
1 secondary outcome
Functional rehabilitation by measure of total usage time, both day and night
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2013.
- Results publication: PubMed 23184201Tedde 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.
- Results publication: PubMed 23147048Tedde 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio B Jatene, MD, PhD study director
Thoracic Surgery Department, Heart Institute (InCor) do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Manuel J Teixeira, MD, PhD study chair
Neurosurgery Department, Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Miguel L Tedde, MD, PhD principal investigator
Thoracic Surgery Department, Heart Institute (InCor) do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuRx RA/4 diaphragmatic pacemaker in people with Respiratory Paralysis and Diaphragmatic Paralysis, run by University of Sao Paulo at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume comparison of the basal with the tidal volume obtained with the NeuRx RA/4 pacemaker in patients with diaphragmatic paralysis (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01385384, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2013.