Clinical trial NCT00448045: Preventing Pneumonia and Other Respiratory Problems in Persons With Spinal Cord Injury
Official title: Prevention of Long-Term Respiratory Complications of Spinal Cord Injury: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spinal Cord Injury
Keywords: Spinal cord injuries
Cough
Peak cough flow
Respiratory therapy
Rehabilitation
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2007-03-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reductions in episodes of community acquired pneumonia (CAP) and related severe respiratory complications
timeFrame: 3 years
Secondary outcomes:
measure: Reductions in hospitalizations due to a primary diagnosis of a respiratory complications
timeFrame: 3 years
measure: Duration of illness and hospitalization
timeFrame: 3 years
measure: Impact of respiratory complications on quality of life and participation
timeFrame: 3 years
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Institute for Rehabilitation
state: New Jersey
Study officials:
affiliation: University of Medicine and Dentistry - The New Jersey Medical School, Newark, N.J.
name: John Bach, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kessler Institute for Rehabilitation, West Orange, N.J.
name: Steven Kirshblum, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kessler Foundation
name: Trevor A. Dyson-Hudson, M.D.
role: STUDY_DIRECTOR
References: