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

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: Spinal Cord Injury
• Intervention / Treatment: Behavioral: Manual and mechanical assisted cough; Behavioral: Incentive spirometry

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• 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

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: Rehabilitation; Cough; Spinal cord injuries; Peak cough flow; Respiratory therapy
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: H133N060022