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

14. januar 2013 oppdatert av: Trevor Dyson-Hudson, M.D., Kessler Foundation

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

120

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • New Jersey
      • West Orange, New Jersey, Forente stater, 07052
        • Kessler Institute for Rehabilitation

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.
Andre navn:
  • CoughAssistTM
  • In-exsufflator
Aktiv komparator: 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.
Atferdsmessig: Incentive spirometry
These individuals will be given a pulse oximeter and an incentive spirometer (AirLife Company) and taught how to use them.
Andre navn:
  • spirometer

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Reductions in episodes of community acquired pneumonia (CAP) and related severe respiratory complications
Tidsramme: 3 years
3 years

Sekundære resultatmål

Resultatmål
Tidsramme
Reductions in hospitalizations due to a primary diagnosis of a respiratory complications
Tidsramme: 3 years
3 years
Duration of illness and hospitalization
Tidsramme: 3 years
3 years
Impact of respiratory complications on quality of life and participation
Tidsramme: 3 years
3 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Kessler Foundation

Samarbeidspartnere

U.S. Department of Education

Etterforskere

  • Hovedetterforsker: John Bach, M.D., University of Medicine and Dentistry - The New Jersey Medical School, Newark, N.J.
  • Hovedetterforsker: Steven Kirshblum, M.D., Kessler Institute for Rehabilitation, West Orange, N.J.
  • Studieleder: Trevor A. Dyson-Hudson, M.D., Kessler Foundation

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2007

Primær fullføring (Faktiske)

1. desember 2012

Studiet fullført (Faktiske)

1. desember 2012

Datoer for studieregistrering

Først innsendt

13. mars 2007

Først innsendt som oppfylte QC-kriteriene

13. mars 2007

Først lagt ut (Anslag)

15. mars 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

15. januar 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. januar 2013

Sist bekreftet

1. januar 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • H133N060022

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