Spinal Cord Injury
Conditions
Keywords
Spinal cord injuries, Cough, Peak cough flow, Respiratory therapy, Rehabilitation
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.
Interventions
BEHAVIORALManual and mechanical assisted cough
Individuals will be given a pulse oximeter and taught both manually assisted and mechanically assisted coughing techniques to maximize their cough. Manually assisted coughing consists of air stacking to deep insufflations. An abdominal thrust is then applied upon glottic opening to augment the cough. These subjects will also have rapid access to a mechanical in-exsufflator (CoughAssistTM) and will be trained on how to access and use this device. Mechanically assisted coughing (MAC) involves the use of the CoughAssistTM to expand the lungs and then quickly reverse the pressure to rapidly empty the lungs with expiratory (cough) flows of 600 L/m. An abdominal (manual) thrust is applied in conjunction with the negative pressure (exsufflation) to further increase cough.
BEHAVIORALIncentive spirometry
These individuals will be given a pulse oximeter and an incentive spirometer (AirLife Company) and taught how to use them.
Sponsors
U.S. Department of Education
Kessler Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reductions in episodes of community acquired pneumonia (CAP) and related severe respiratory complications | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Duration of illness and hospitalization | 3 years |
| Impact of respiratory complications on quality of life and participation | 3 years |
| Reductions in hospitalizations due to a primary diagnosis of a respiratory complications | 3 years |
Countries
United States
Outcome results
None listed