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Preventing Pneumonia and Other Respiratory Problems in Persons With Spinal Cord Injury

Phase 2
Completed
Conditions
Spinal Cord Injury
Registration Number
NCT00448045
Lead Sponsor
Kessler Foundation
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 vital to deep breathing and the ability to cough. The purpose of this study is to look at the effectiveness of two different treatments in preventing pneumonia and other respiratory problems in persons with SCI.

This is a randomized controlled trial investigating the effectiveness of two different treatments. Participants will be randomly assigned to one of the two treatment groups. They will not be told the details of the other intervention since this could influence or change their activities during the study.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
120
Inclusion Criteria
  • 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 Criteria
  • 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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Reductions in episodes of community acquired pneumonia (CAP) and related severe respiratory complications3 years
Secondary Outcome Measures
NameTimeMethod
Reductions in hospitalizations due to a primary diagnosis of a respiratory complications3 years
Impact of respiratory complications on quality of life and participation3 years
Duration of illness and hospitalization3 years

Trial Locations

Locations (1)

Kessler Institute for Rehabilitation

🇺🇸

West Orange, New Jersey, United States

Kessler Institute for Rehabilitation
🇺🇸West Orange, New Jersey, United States

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