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Impact of Continuous Positive Airway Pressure on Breathing Motion Amplitude

13. oktober 2016 opdateret af: Erik J. Tryggestad, Ph.D., Mayo Clinic

This study involves a breathing motion assessment in healthy subjects before and after continuous positive airway pressure (CPAP) administration using MRI images.

The hypothesis for this study is that CPAP administration will significantly reduce breathing motion. This may help cancer patients who are undergoing proton radiotherapy, so they possibly will not have to hold their breath during the procedure.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Minimally invasive techniques for tumor motion reduction that involve free-breathing patients have significant relevance in the context of radiation therapy, in particular proton radiotherapy. Tumor motion reduction has favorable implications for reduction of radiation doses to adjacent healthy organs, radiation plan robustness (accuracy/quality) and for treatment efficiency (reduction of treatment times). Using non-ionizing MRI with volunteers, the investigators will determine the extent to which continuous positive airway pressure (CPAP) reduces breathing motion (diaphragmatic excursion). The researchers will also investigate the parameter space associated with breathing motion reduction versus the amount of pressure applied, as well as timing of initiation of CPAP in relation to the imaging time point (to address whether an initial transient breathing state exists).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

10

Fase

  • Tidlig fase 1

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic in Rochester

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Healthy adult female and males
  2. Subject meets routine MRI safety criteria

Exclusion Criteria:

  1. Age <18
  2. Known history of chronic obstructive pulmonary disease (COPD), asthma, or other chronic pulmonary illness
  3. Pregnancy
  4. Any safety risk identified via MRI safety screening

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Continuous Positive Airway Pressure
Continuous Positive Airway Pressure (CPAP) will be administered using FDA-approved equipment.
Andet: Continuous Positive Airway Pressure
CPAP requires subjects to wear a plastic pressurized mask/apparatus, which is connected via a filter and hose to a pump capable of supplying variable pressure (typically on the range of 4-20 cm H2O). The investigators plan to use a full-face mask to prevent subjects from reducing pressure by opening their mouths. If this cannot be tolerated or properly fitted, or is not compatible with the CPAP ventilator, subjects would use a nasal mask only and be asked to keep their mouths closed.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Breathing Motion Characteristics at High CPAP Setting
Tidsramme: Data acquisition for this portion of the study will require approximately 30 minutes.
Breathing motion at baseline and at initial (higher but tolerable) CPAP settings will be characterized using fast multi-slice, multi-phase 2D gradient-echo or spin-echo MRI sequences in the sagittal or coronal imaging planes over a large field of view covering the thoracic and upper-abdominal region. Specifically "4D-MRI" (or time-resolved MRI) will be generated from retrospective sorting of multi-slice 2D MRI. For these analyses, anatomic reference points (e.g., bright vessels) in multiple organ systems will be identified on the images, contoured or segmented; subsequently 3D motion patterns will be extracted for all anatomical references/features. Numerical simulations will be performed to determine hypothetical radiation target volume changes (cm^3) at these anatomic locations assuming spherical tumors with a given set of tumor diameters (cm).
Data acquisition for this portion of the study will require approximately 30 minutes.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Breathing Motion Characteristics at Lower CPAP Setting
Tidsramme: Approximately 45 minutes into visit.
Time permitting, the CPAP setting will be reduced to approximately half of the nominal/tolerable/high CPAP setting. Using the same MRI sequences and retrospective sorting technique, 4D-MRI will be generated for this lower CPAP setting. Analogous motion characterization analyses (to outcome measure 1) will be carried out for the lower CPAP setting (relative to baseline 4D-MRI).
Approximately 45 minutes into visit.

Samarbejdspartnere og efterforskere

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

Sponsor

Mayo Clinic

Efterforskere

  • Ledende efterforsker: Erik J Tryggestad, PhD, Mayo Clinic

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. juli 2016

Primær færdiggørelse (Faktiske)

1. september 2016

Studieafslutning (Faktiske)

1. september 2016

Datoer for studieregistrering

Først indsendt

3. juni 2016

Først indsendt, der opfyldte QC-kriterier

28. juli 2016

Først opslået (Skøn)

2. august 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. oktober 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. oktober 2016

Sidst verificeret

1. oktober 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 16-001685

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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