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

January 14, 2013 updated by: Trevor Dyson-Hudson, M.D., Kessler Foundation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • West Orange, New Jersey, United States, 07052
        • Kessler Institute for Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • CoughAssistTM
  • In-exsufflator
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 Names:
  • spirometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reductions in episodes of community acquired pneumonia (CAP) and related severe respiratory complications
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Reductions in hospitalizations due to a primary diagnosis of a respiratory complications
Time Frame: 3 years
3 years
Duration of illness and hospitalization
Time Frame: 3 years
3 years
Impact of respiratory complications on quality of life and participation
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kessler Foundation

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

March 13, 2007

First Submitted That Met QC Criteria

March 13, 2007

First Posted (Estimate)

March 15, 2007

Study Record Updates

Last Update Posted (Estimate)

January 15, 2013

Last Update Submitted That Met QC Criteria

January 14, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H133N060022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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