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

NCT00448045 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2013-01-15

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • U.S. Department of Education

    collaborator FED
  • Kessler Foundation

    lead OTHER

Principal Investigators

  • John Bach, M.D. · University of Medicine and Dentistry - The New Jersey Medical School, Newark, N.J.

  • Steven Kirshblum, M.D. · Kessler Institute for Rehabilitation, West Orange, N.J.

  • Trevor A. Dyson-Hudson, M.D. · Kessler Foundation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00448045 on ClinicalTrials.gov