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NCT Number: NCT00448045

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

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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Cough Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kessler Institute for Rehabilitation

West Orange, New Jersey, 07052, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Manual and mechanical assisted cough

Behavioral

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

Incentive spirometry

Behavioral

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

Other names: spirometer

Primary outcomes

  1. Reductions in episodes of community acquired pneumonia (CAP) and related severe respiratory complications

    Time frame: 3 years

Secondary outcomes

  1. Reductions in hospitalizations due to a primary diagnosis of a respiratory complications

    Time frame: 3 years

  2. Duration of illness and hospitalization

    Time frame: 3 years

  3. Impact of respiratory complications on quality of life and participation

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Collaborators

  • U.S. Department of Education

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Mar 15, 2007
Registry last updated
Jan 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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