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

Primary Purpose

Spinal Cord Injury

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Manual and mechanical assisted cough

Incentive spirometry

About this trial

This is an interventional prevention trial for Spinal Cord Injury focused on measuring Spinal cord injuries, Cough, Peak cough flow, Respiratory therapy, Rehabilitation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Kessler Institute for Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Manual and mechanical assisted cough

Incentive spirometry

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Duration of illness and hospitalization

Impact of respiratory complications on quality of life and participation

Full Information

NCT ID

NCT00448045

First Posted

March 13, 2007

Last Updated

January 14, 2013

Sponsor

Kessler Foundation

Collaborators

U.S. Department of Education

1. Study Identification

Unique Protocol Identification Number

NCT00448045

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kessler Foundation

Collaborators

U.S. Department of Education

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injury

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Manual and mechanical assisted cough

Arm Type

Experimental

Arm Description

Arm Title

Incentive spirometry

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Manual and mechanical assisted cough

Other Intervention Name(s)

CoughAssistTM, In-exsufflator

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Incentive spirometry

Other Intervention Name(s)

spirometer

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

3 years

Secondary Outcome Measure Information:

Title

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

Time Frame

3 years

Title

Duration of illness and hospitalization

Time Frame

3 years

Title

Impact of respiratory complications on quality of life and participation

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Bach, M.D.

Organizational Affiliation

University of Medicine and Dentistry - The New Jersey Medical School, Newark, N.J.

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Steven Kirshblum, M.D.

Organizational Affiliation

Kessler Institute for Rehabilitation, West Orange, N.J.

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Trevor A. Dyson-Hudson, M.D.

Organizational Affiliation

Kessler Foundation

Official's Role

Study Director

Facility Information:

Facility Name

Kessler Institute for Rehabilitation

City

West Orange

State/Province

New Jersey

ZIP/Postal Code

07052

Country

United States

12. IPD Sharing Statement

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

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