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

NCT00448045 | Completed Phase 2 DMC

• 1 other identifier: H133N060022
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Spinal cord injuries; Cough; Peak cough flow; Respiratory therapy; Rehabilitation

Outcome Measures

Primary Outcomes (1)

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

  3 years

Secondary Outcomes (3)

• Reductions in hospitalizations due to a primary diagnosis of a respiratory complications

  3 years

• Duration of illness and hospitalization

  3 years

• Impact of respiratory complications on quality of life and participation

  3 years

Study Arms (2)

Manual and mechanical assisted cough

EXPERIMENTAL

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

Incentive spirometry

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: CoughAssistTM, In-exsufflator

Manual and mechanical assisted cough

Incentive spirometry BEHAVIORAL

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

Also known as: spirometer

Incentive spirometry

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kessler Foundation: lead
• U.S. Department of Education: collaborator

Study Sites (1)

Kessler Institute for Rehabilitation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Cough

Condition Hierarchy (Ancestors)

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

Study Officials

• 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.

  PRINCIPAL INVESTIGATOR

• Trevor A. Dyson-Hudson, M.D.

  Kessler Foundation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interim-Director, Spinal Cord Injury Research

Study Record Dates

• First Submitted: March 13, 2007
• First Posted: March 15, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 15, 2013

Record last verified: 2013-01

Locations

US (1)