Status:
COMPLETED
Preventing Pneumonia and Other Respiratory Problems in Persons With Spinal Cord Injury
Lead Sponsor:
Kessler Foundation
Collaborating Sponsors:
U.S. Department of Education
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
It is known that individuals with spinal cord injury are at increased risk for respiratory tract infections like pneumonia. Part of this risk is due to weakened chest and abdominal muscles that are vi...
Eligibility Criteria
Inclusion
- Chronic spinal cord injury that occurred more than 6 months ago
- An impaired ability to cough (cough peak flow less than 300 L/min)
- Oxygen saturation greater than or equal to 95% when awake and not receiving supplemental oxygen
- End-tidal carbon dioxide level less than 43 mm Hg
- Without a fever or other signs of an acute illness for the previous 2 weeks
- Able to learn the treatment protocol and have someone available at home to assist if needed to help set-up and use the equipment
Exclusion
- Under 18 years of age
- Currently have a tracheotomy tube
- Have a history of an acute illness in the last 2 weeks
- Have lung disease as seen on chest x-ray that results in a baseline oxygen saturation decreasing below 95% during daytime hours and cannot be normalized by usual way of coughing
- Already utilizing an oximetry protocol
- Have a significant medical complication and psychiatric condition that would interfere with the conduct of the study or interpretation of the study results.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00448045
Start Date
June 1 2007
End Date
December 1 2012
Last Update
January 15 2013
Active Locations (1)
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1
Kessler Institute for Rehabilitation
West Orange, New Jersey, United States, 07052