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

Completed · Phase 2

Conditions studied: Spinal Cord Injury

In brief

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.

Key facts

Study ID: NCT00448045
Run by: Kessler Foundation
People needed: 120
Starts: 2007-06-01
Expected to finish: 2012-12-01
Last updated by the study team: 2013-01-15

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Kessler Institute for Rehabilitation — West Orange, New Jersey, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.