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Physiology and Structure of the Small Airways in Patients With Chronic Airflow Obstruction or COVID-19 (PASSPORT)

18. januar 2021 opdateret af: Imperial College London
The purpose of this research project is to study small airways physiological function in patients with chronic obstructive lung disease or COVID-19 and explore the relationship with in-vivo microanatomical small airway structure as measured by OCT. Correlating endobronchial assessment with multiple breath nitrogen washout and impulse oscillometry will allow the characterisation of the relationship between small airway structural findings and these validated investigations. A small volume lung wash, endobronchial brushings and the collection of a limited number of endobronchial cryobiopsy samples will be performed to better understand the endobronchial environment of the small airways through inflammatory studies. Following the completion of any such work, residual samples will be stored in a "bio-bank" to enable the completion of future work. Understanding the relationship with symptom-based quality of life scoring questionnaires and a functional assessment of exercise capacity will help elucidate the clinical impact of in-vivo small airways findings.

Studieoversigt

Status

Ukendt

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Forventet)

42

Kontakter og lokationer

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

Studiekontakt

Studiesteder

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

16 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Subjects over the age of 16 with either chronic airflow obstruction or COVID-19

Beskrivelse

Inclusion Criteria:

  1. Age 16 or over
  2. Scheduled for bronchoscopy as part of clinical care or research protocol
  3. No bleeding diathesis or therapeutic anticoagulation

  4. COPD:

    • FEV1/FVC ratio <70% or

Asthma:

  • Diagnosed by standard clinical methods
  • Post-bronchodilator FEV1 ≥60% predicted or COVID-19 infection or previous COVID-19 infection (confirmed as per local guidelines)

Exclusion Criteria:

  1. Unable to provide informed consent
  2. Exacerbation of obstructive airways disease or respiratory infection requiring systemic antibiotics or corticosteroids in the 6 weeks prior to enrolment unless suffering from COVID-19 infection and bronchoscopy is required for clinical reasons

  3. Contra-indications to performing lung function testing

    • Aortic aneurysm >6cm
    • Unstable cardiovascular disease (unstable angina, myocardial infarction or pulmonary embolism <4 weeks prior)
    • Severe aortic stenosis
    • Pneumothorax
    • Cerebral aneurysm
    • Thoracic or abdominal surgery <4 weeks prior

  4. Contra-indications to passing oesophageal balloons

    • Oesophageal ulceration or varices
    • Sinusitis, recent nasal surgery or epistaxis

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Chronic Airflow obstruction / COVID-19
Patients with either chronic airflow obstruction of COVID-19

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Respiratory resistance at 5Hz - 20Hz (R5-R20) (kPa/l/s) related to airtrapping as determined by quantitative CT (Expiratory phase low attenuation area <856 HU (%LAA <856 HU)
Tidsramme: Baseline, pre-procedure
Impulse Oscillometry
Baseline, pre-procedure

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Respiratory reactance at 5Hz: X5 (kPa/l/s)
Tidsramme: Baseline, pre-procedure
Impulse Oscillometry
Baseline, pre-procedure
Reactance area: Ax (kPa/l/s)
Tidsramme: Baseline, pre-procedure
Impulse Oscillometry
Baseline, pre-procedure
Functional residual capacity by MBNW: FRCgas (L)
Tidsramme: Baseline, pre-procedure
Multiple Breath Nitrogen Washout
Baseline, pre-procedure
Lung clearance index: LCI
Tidsramme: Baseline, pre-procedure
Multiple Breath Nitrogen Washout
Baseline, pre-procedure
Ventilation heterogeneity conducting airways: Scond (L/s)
Tidsramme: Baseline, pre-procedure
Multiple Breath Nitrogen Washout
Baseline, pre-procedure
Ventilation heterogeneity acinar airways: Sacin (L/s)
Tidsramme: Baseline, pre-procedure
Multiple Breath Nitrogen Washout
Baseline, pre-procedure
Forced expiratory volume in 1 second: FEV1 (L)
Tidsramme: Baseline, pre-procedure
Spirometry
Baseline, pre-procedure
Forced vital capacity: FVC (L)
Tidsramme: Baseline, pre-procedure
Spirometry
Baseline, pre-procedure
Total lung capacity: TLC (L)
Tidsramme: Baseline, pre-procedure
Plethysmography
Baseline, pre-procedure
Residual volume: RV (L)
Tidsramme: Baseline, pre-procedure
Plethysmography
Baseline, pre-procedure
Functional residual capacity by plethysmography: FRCpleth (L)
Tidsramme: Baseline, pre-procedure
plethysmography
Baseline, pre-procedure
Airway mean luminal diameter (Dmean)
Tidsramme: Baseline, during the procedure
Optical Coherence Tomography
Baseline, during the procedure
Airway inner lumen area (Ai)
Tidsramme: Baseline, during the procedure
Optical Coherence Tomography
Baseline, during the procedure
Airway wall area (Aw), airway wall percentage (Aw%) as determined by [Aw/(Ai + Aw) × 100%]
Tidsramme: Baseline, during the procedure
Optical Coherence Tomography
Baseline, during the procedure
Air trapping - expiratory phase low attenuation area <856 HU (%LAA <856 HU)
Tidsramme: Baseline, pre-procedure
Quantitative CT
Baseline, pre-procedure
Modified MRC dyspnoea score
Tidsramme: Baseline, pre-procedure
Patient reported outcome measure
Baseline, pre-procedure
St George's Respiratory Questionnaire Score
Tidsramme: Baseline, pre-procedure
Patient reported outcome measure
Baseline, pre-procedure
Asthma-related Quality of Life Questionnaire (AQLQ) (if asthmatic)
Tidsramme: Baseline, pre-procedure
Patient reported outcome measure
Baseline, pre-procedure
Asthma Control Questionnaire (ACQ) (if asthmatic)
Tidsramme: Baseline, pre-procedure
Patient reported outcome measure
Baseline, pre-procedure
6-minute walk distance (m)
Tidsramme: Baseline, pre-procedure
6-minute walk distance (m)
Baseline, pre-procedure

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Exploratory: Inflammatory and pathological studies of airways brush, wash and cryobiopsy samples
Tidsramme: Baseline, during the procedure
Laboratory based scientific studies
Baseline, during the procedure

Samarbejdspartnere og efterforskere

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

Sponsor

Imperial College London

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 (Faktiske)

23. august 2019

Primær færdiggørelse (Forventet)

22. august 2021

Studieafslutning (Forventet)

2. februar 2022

Datoer for studieregistrering

Først indsendt

2. juli 2020

Først indsendt, der opfyldte QC-kriterier

18. januar 2021

Først opslået (Faktiske)

20. januar 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. januar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. januar 2021

Sidst verificeret

1. januar 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 18IC4688

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