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| Name | Class |
|---|---|
| U.S. Department of Education | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual and mechanical assisted cough | Experimental | 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. |
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| Incentive spirometry | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual and mechanical assisted cough | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reductions in episodes of community acquired pneumonia (CAP) and related severe respiratory complications | 3 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Bach, M.D. | University of Medicine and Dentistry - The New Jersey Medical School, Newark, N.J. | Principal Investigator |
| Steven Kirshblum, M.D. | Kessler Institute for Rehabilitation, West Orange, N.J. | Principal Investigator |
| Trevor A. Dyson-Hudson, M.D. | Kessler Foundation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kessler Institute for Rehabilitation | West Orange | New Jersey | 07052 | United States |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D003371 | Cough |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| Incentive spirometry | Behavioral | These individuals will be given a pulse oximeter and an incentive spirometer (AirLife Company) and taught how to use them. |
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| 3 years |
| D014947 | Wounds and Injuries |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |