Preventing Pneumonia and Other Respiratory Problems in Persons With Spinal Cord Injury
This study is ongoing, but not recruiting participants.
Sponsor:
Kessler Foundation
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Trevor Dyson-Hudson, M.D., Kessler Foundation
ClinicalTrials.gov Identifier:
NCT00448045
First received: March 13, 2007
Last updated: May 22, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Spinal Cord Injury |
Behavioral: Manual and mechanical assisted cough Behavioral: Incentive spirometry |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Prevention of Long-Term Respiratory Complications of Spinal Cord Injury: a Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by Kessler Foundation:
Primary Outcome Measures:
- Reductions in episodes of community acquired pneumonia (CAP) and related severe respiratory complications [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Reductions in hospitalizations due to a primary diagnosis of a respiratory complications [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Duration of illness and hospitalization [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Impact of respiratory complications on quality of life and participation [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 160 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Manual 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 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
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.
Other Names:
|
|
Active Comparator: Incentive spirometry
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
These individuals will be given a pulse oximeter and an incentive spirometer (AirLife Company) and taught how to use them.
Other Name: spirometer
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00448045
Locations
| United States, New Jersey | |
| Kessler Institute for Rehabilitation | |
| West Orange, New Jersey, United States, 07052 | |
Sponsors and Collaborators
Kessler Foundation
U.S. Department of Education
Investigators
| Principal Investigator: | 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. |
| Study Director: | Trevor A. Dyson-Hudson, M.D. | Kessler Foundation |
More Information
No publications provided
| Responsible Party: | Trevor Dyson-Hudson, M.D., Interim-Director, Spinal Cord Injury Research, Kessler Foundation |
| ClinicalTrials.gov Identifier: | NCT00448045 History of Changes |
| Other Study ID Numbers: | H133N060022 |
| Study First Received: | March 13, 2007 |
| Last Updated: | May 22, 2012 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Kessler Foundation:
|
Spinal cord injuries Cough Peak cough flow Respiratory therapy Rehabilitation |
Additional relevant MeSH terms:
|
Spinal Cord Injuries Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on October 01, 2012
