Spinal Cord InjuryPhase 2NCT00448045
Preventing Pneumonia and Other Respiratory Problems in Persons With Spinal Cord Injury
A Phase 2 study testing Manual and mechanical assisted cough and Incentive spirometry in people with Spinal Cord Injury, run by Kessler Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Manual and mechanical assisted cough and Incentive spirometry
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Dec 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Kessler Institute for Rehabilitation
West Orange, New Jersey, 07052
About this study
Official title: 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.
- Conditions
- Spinal Cord Injury
- Being tested
- Manual and mechanical assisted cough, Incentive spirometry
- Keywords
- Spinal cord injuries, Cough, Peak cough flow, Respiratory therapy, Rehabilitation
- Medical subject headings
- Spinal Cord Injuries, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual and mechanical assisted coughBehavioural
Also called CoughAssistTM, In-exsufflator
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.
Incentive spirometryBehavioural
Also called spirometer
These individuals will be given a pulse oximeter and an incentive spirometer (AirLife Company) and taught how to use them.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Incentive spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reductions in episodes of community acquired pneumonia (CAP) and related severe respiratory complications
Measured: 3 years
Secondary outcomes (3)
Reductions in hospitalizations due to a primary diagnosis of a respiratory complications
Measured: 3 years
Duration of illness and hospitalization
Measured: 3 years
Impact of respiratory complications on quality of life and participation
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
- Responsible party
- Principal investigator, Trevor Dyson-Hudson, M.D., Kessler Foundation
- Investigators
- John Bach, M.D., Principal investigator, University of Medicine and Dentistry - The New Jersey Medical School, Newark, N.J.Steven Kirshblum, M.D., Principal investigator, Kessler Institute for Rehabilitation, West Orange, N.J.Trevor A. Dyson-Hudson, M.D., Study director, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448045
- Sponsor's protocol ID
- H133N060022
- Status last verified
- Jan 2013
- First submitted
- 13 Mar 2007
- Last updated
- 15 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Long-Term Respiratory Complications of Spinal Cord Injury: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00448045
- Acronym / sponsor ID
- H133N060022
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal cord injuries, Cough, Peak cough flow, Respiratory therapy, Rehabilitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- Jun 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual and mechanical assisted cough | Experimental | Behavioral: Manual and mechanical assisted coughIndividuals 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. |
| Incentive spirometry | Active comparator | Behavioral: Incentive spirometryThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual and mechanical assisted coughAlso: CoughAssistTM, In-exsufflatorIndividuals 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. | Behavioural | Manual and mechanical assisted cough |
| Incentive spirometryAlso: spirometerThese individuals will be given a pulse oximeter and an incentive spirometer (AirLife Company) and taught how to use them. | Behavioural | Incentive spirometry |
Primary outcome
Reductions in episodes of community acquired pneumonia (CAP) and related severe respiratory complications
Time frame: 3 years
3 secondary outcomes
Reductions in hospitalizations due to a primary diagnosis of a respiratory complications
Time frame: 3 years
Duration of illness and hospitalization
Time frame: 3 years
Impact of respiratory complications on quality of life and participation
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Bach, M.D. principal investigator
University of Medicine and Dentistry - The New Jersey Medical School, Newark, N.J.
Steven Kirshblum, M.D. principal investigator
Kessler Institute for Rehabilitation, West Orange, N.J.
Trevor A. Dyson-Hudson, M.D. study director
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Manual and mechanical assisted cough and Incentive spirometry in people with Spinal Cord Injury, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reductions in episodes of community acquired pneumonia (CAP) and related severe respiratory complications (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2013.