NCT00448045

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Kessler Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
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.
BEHAVIORAL	Incentive spirometry	These individuals will be given a pulse oximeter and an incentive spirometer (AirLife Company) and taught how to use them.

Timeline

• Start date: 2007-06-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2007-03-15
• Last updated: 2013-01-15

Locations

1 site across 1 country: United States