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

Kessler Foundation

Status and phase: Completed; Phase 2

Conditions: Spinal Cord Injury

Treatments: Behavioral: Incentive spirometry; Behavioral: Manual and mechanical assisted cough

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00448045

H133N060022

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Manual and mechanical assisted cough

Experimental group

Description:

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.

Treatment:

Behavioral: Manual and mechanical assisted cough

Incentive spirometry

Active Comparator group

Description:

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.

Treatment:

Behavioral: Incentive spirometry