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Electrical Activation of The Diaphragm for Ventilatory Assist

This study is currently recruiting participants.
Verified by Synapse Biomedical, May 2008

Sponsors and Collaborators: Synapse Biomedical
University Hospitals of Cleveland
Shepherd Center in Atlanta
Information provided by: Synapse Biomedical
ClinicalTrials.gov Identifier: NCT00010374
  Purpose

OBJECTIVES:

The objectives of this study are to test the Diaphragm Pacing Stimulation (DPS) System for treating chronic ventilatory insufficiency in persons with respiratory muscle paralysis. The hypothesis being tested in the clinical trial is that laparoscopic stimulation of the diaphragm at the motor point with intramuscular electrodes is safe and effective in providing significant ventilatory support to individuals who are otherwise dependant on a mechanical ventilator. Patients in our initial study group have all suffered from high-level spinal cord injury and were full-time dependant on positive pressure mechanical ventilation prior to inclusion.


Condition Intervention
Spinal Cord Injury
Quadriplegia
Device: intramuscular diaphragm electrodes
Device: Intramuscular diaphragm electrodes

MedlinePlus related topics:   Spinal Cord Injuries   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:   Multi-Center Pivotal Study of NeuRx RA/4 Ventilatory Assist Device

Further study details as provided by Synapse Biomedical:

Primary Outcome Measures:
  • Clinically acceptable tidal volume sustained over a continuous 4 hour period. [ Time Frame: Within one year after implantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse event rate from time of electrode implant compared to published adverse event rates in a similar patient population using ventilator support. [ Time Frame: After completion of the study ] [ Designated as safety issue: Yes ]
  • Reduction of dependence on mechanical ventilation. Improvement in the quality of life for patient and caregiver. [ Time Frame: Within one year of implantation ] [ Designated as safety issue: No ]

Estimated Enrollment:   50
Study Start Date:   February 2000
Estimated Study Completion Date:   October 2008
Estimated Primary Completion Date:   October 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
The objective of this study is to assess the safety and efficacy of the NeuRx RA/4 for diaphragm pacing compared to mechanical ventilator support.
Device: intramuscular diaphragm electrodes
Conditioning of the diaphragm
2: Experimental
To test the safety, efficacy and clinical utility of diaphragm pacing using IM electrodes placed through a laparoscopic approach to achieve artificial ventilation in spinal cord injured patients who have an internal cardiac pacemaker and require full-time ventilator support.
Device: intramuscular diaphragm electrodes
Conditioning of the diaphragm
Device: Intramuscular diaphragm electrodes
to test the safety, efficacy and clinical utility of diaphragm pacing using IM electrodes placed through a laparoscopic approach to achieve artificial ventilation in spinal cord injured patients who have an internal cardiac pacemaker and require full-time ventilator support.

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • High cervical spinal cord injury resulting in tetraplegia
  • Respiratory failure that requires chronic mechanical ventilatory support
  • Failure of vigorous attempts to wean from ventilatory support

Normal bilateral phrenic nerve function required

--Patient Characteristics--

Performance status: Stable condition

Cardiovascular: No active cardiovascular disease

Pulmonary: No active lung disease

Other:

  • No active brain disease
  • No significant scoliosis, chest wall deformity, or obesity
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00010374

Locations
United States, Colorado
Craig Hospital     Recruiting
      Englewood, Colorado, United States, 80113-2811
      Contact: Daniel P. Lammertse, MD     303-789-8220     DLammertse@CraigHospital.org    
      Principal Investigator: Daniel P. Lammertse, MD            
United States, Georgia
Shepherd Center     Recruiting
      Atlanta, Georgia, United States, 30309-1465
      Contact: Michelle E. Nemeth, P.T.     404-350-7688     Michelle_Nemeth@shepherd.org    
      Principal Investigator: Brock Bowman, MD            
United States, Ohio
University Hospital Of Cleveland     Recruiting
      Cleveland, Ohio, United States, 44106
      Contact: Mary Jo Elmo, NP     216-844-8594     maryjo.elmo@uhhs.com    
      Principal Investigator: Raymond P. Onders, MD            
United States, Texas
The Methodist Hospital     Recruiting
      Houston, Texas, United States, 77030
      Contact: Brian J. Dunkin, MD, FACS     713-441-6382     BJDunkin@tmh.tmc.edu    
      Contact: Linda W. Moore, CCRP     713 441 6144     LWMoore@tmh.tmc.edu    
      Principal Investigator: Brian J. Dunkin, MD, FACS            
Canada, British Columbia
Vancouver CoastHealth     Recruiting
      Vancouver, British Columbia, Canada, V5Z 1M9
      Contact: Jeremy Road, MD     604-875-4111 ext 67916     Jeremy.Road@vch.ca    
      Contact: Giselle Gerdak, Clinical Research Coordinator     604-875-5091     Giselle.Gerdak@vch.ca    
      Principal Investigator: Jeremy Road, MD            

Sponsors and Collaborators
Synapse Biomedical
University Hospitals of Cleveland
Shepherd Center in Atlanta

Investigators
Principal Investigator:     Raymond Onders, MD     University Hospitals of Cleveland    
  More Information

Responsible Party:   University Hospitals of Cleveland ( Raymond Onders, MD )
Study ID Numbers:   CLIN 20-0000-0009
First Received:   February 2, 2001
Last Updated:   May 2, 2008
ClinicalTrials.gov Identifier:   NCT00010374
Health Authority:   United States: Food and Drug Administration;   United States: Institutional Review Board

Keywords provided by Synapse Biomedical:
Diaphragm for Ventilatory Assist  
environmental/toxic disorders  
neurologic and psychiatric disorders  
rare disease  
spinal cord injury  

Study placed in the following topic categories:
Paralysis
Signs and Symptoms
Spinal Cord Injuries
Spinal Cord Diseases
Mental Disorders
Wounds and Injuries
Rare Diseases
Disorders of Environmental Origin
Central Nervous System Diseases
Neurologic Manifestations
Trauma, Nervous System
Quadriplegia

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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