Electrical Activation of The Diaphragm for Ventilatory Assist - Full Text View

Sponsor:	Synapse Biomedical
Collaborators:	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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Multi-Center Pivotal Study of NeuRx RA/4 Ventilatory Assist Device

Resource links provided by NLM:

MedlinePlus related topics: Spinal Cord Injuries

U.S. FDA Resources

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
Experimental: 1 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
Experimental: 2 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.

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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
Englewood, Colorado, United States, 80113-2811
United States, Georgia
Shepherd Center
Atlanta, Georgia, United States, 30309-1465
United States, Ohio
University Hospital Of Cleveland
Cleveland, Ohio, United States, 44106
United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
Canada, British Columbia
Vancouver CoastHealth
Vancouver, British Columbia, Canada, V5Z 1M9

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

No publications provided

Responsible Party:	Raymond Onders, MD, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:	NCT00010374 History of Changes
Other Study ID Numbers:	CLIN 20-0000-0009
Study First Received:	February 2, 2001
Last Updated:	September 15, 2008
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

Additional relevant MeSH terms:

Quadriplegia
Spinal Cord Injuries
Paralysis
Neurologic Manifestations
Nervous System Diseases

Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on February 12, 2012