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

14. januar 2013 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

120

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New Jersey
      • West Orange, New Jersey, Forenede Stater, 07052
        • Kessler Institute for Rehabilitation

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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 navne:
  • 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.
Adfærdsmæssigt: Incentive spirometry
These individuals will be given a pulse oximeter and an incentive spirometer (AirLife Company) and taught how to use them.
Andre navne:
  • spirometer

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Kessler Foundation

Samarbejdspartnere

U.S. Department of Education

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2007

Primær færdiggørelse (Faktiske)

1. december 2012

Studieafslutning (Faktiske)

1. december 2012

Datoer for studieregistrering

Først indsendt

13. marts 2007

Først indsendt, der opfyldte QC-kriterier

13. marts 2007

Først opslået (Skøn)

15. marts 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

15. januar 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. januar 2013

Sidst verificeret

1. januar 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • H133N060022

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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