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

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.

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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	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

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