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

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00448045
• Other study ID #: H133N060022
• Status: Completed
• Phase: Phase 2
• First received: March 13, 2007
• Last updated: January 14, 2013
• Start date: June 2007
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

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

Locations

Country	Name	City	State
United States	Kessler Institute for Rehabilitation	West Orange	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Kessler Foundation	U.S. Department of Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reductions in episodes of community acquired pneumonia (CAP) and related severe respiratory complications		3 years	No
Secondary	Reductions in hospitalizations due to a primary diagnosis of a respiratory complications		3 years	No
Secondary	Duration of illness and hospitalization		3 years	No
Secondary	Impact of respiratory complications on quality of life and participation		3 years	No