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- Klinische proef NCT00448045
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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New Jersey
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West Orange, New Jersey, Verenigde Staten, 07052
- Kessler Institute for Rehabilitation
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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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.
Andere namen:
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Actieve vergelijker: 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.
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These individuals will be given a pulse oximeter and an incentive spirometer (AirLife Company) and taught how to use them.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Reductions in episodes of community acquired pneumonia (CAP) and related severe respiratory complications
Tijdsspanne: 3 years
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3 years
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Reductions in hospitalizations due to a primary diagnosis of a respiratory complications
Tijdsspanne: 3 years
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3 years
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Duration of illness and hospitalization
Tijdsspanne: 3 years
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3 years
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Impact of respiratory complications on quality of life and participation
Tijdsspanne: 3 years
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3 years
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: John Bach, M.D., University of Medicine and Dentistry - The New Jersey Medical School, Newark, N.J.
- Hoofdonderzoeker: Steven Kirshblum, M.D., Kessler Institute for Rehabilitation, West Orange, N.J.
- Studie directeur: Trevor A. Dyson-Hudson, M.D., Kessler Foundation
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- H133N060022
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