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

Study Overview
=================
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.

Official Title
-----------------
Prevention of Long-Term Respiratory Complications of Spinal Cord Injury: a Randomized Controlled Trial

Conditions
-----------------
Spinal Cord Injury

Intervention / Treatment
-----------------
* Behavioral: Manual and mechanical assisted cough
* Behavioral: Incentive spirometry


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manual and mechanical assisted cough<br>Individuals will be given a pulse oximeter and taught both manually assisted and mechanically assisted coughing techniques to maximize their cough peak flow. Manually assisted coughing consists of air stacking to deep insufflations. An abdominal thrust is then applied upon glottic opening to augment the cough peak flow. 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. | Behavioral: Manual and mechanical assisted cough<br>* 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.<br>* Other names: In-exsufflator;|
| Active Comparator: Incentive spirometry<br>The active control group will consist of individuals assigned to the oximetry with incentive spirometry group. These individuals will be given a pulse oximeter and an incentive spirometer (AirLife Company) and taught how to use them. | Behavioral: Incentive spirometry<br>* These individuals will be given a pulse oximeter and an incentive spirometer (AirLife Company) and taught how to use them.<br>* Other names: spirometer;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reductions in episodes of community acquired pneumonia (CAP) and related severe respiratory complications |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reductions in hospitalizations due to a primary diagnosis of a respiratory complications |  | 3 years | 
| Duration of illness and hospitalization |  | 3 years | 
| Impact of respiratory complications on quality of life and participation |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal cord injuries, Cough, Peak cough flow, Respiratory therapy, Rehabilitation