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Pulmonary Hemodynamics in Patients With Severe Emphysema Pre and Post BLVR

1. januar 2017 opdateret af: Mostafa Elshazly, Cairo University

Pulmonary Hemodynamics in Patients With Severe Emphysema Pre and Post Bronchoscopic Volume Reduction by Histoacryl or Silver Nitrate (Single Center Experince )

This study is designed as a prospective study, with the primary endpoint being changes in pulmonary hemodynamic parameters after ELVR in patients with severe emphysema.

Secondary endpoints will be changes in lung function parameters, exercise capacity, and QoL.

Studieoversigt

Detaljeret beskrivelse

Chronic obstructive pulmonary disease (COPD) continues to be a leading cause of morbidity and is currently the third most common cause of mortality worldwide (1).

In most patients with severe COPD, chronic airflow limitation, lung emphysema with parenchymal destruction and the development of air bullae also occur (2-3) Pulmonary hypertension (PH) is a common consequence of COPD, although the actual overall prevalence of PH in COPD remains unclear (4). Among COPD patients who were to undergo lung-volume-reduction surgery or lung transplantation, mild PH was observed in 50.2%, moderate PH in 9.8%, and severe PH in 3.7%(5). While in most COPD patients who develop PH, pulmonary arterial pressure is only mildly or moderately elevated, (6) PH has an independent prognostic impact on survival. (6,7) The therapeutic options for COPD patients with severe emphysema are limited. Lung volume reduction surgery (LVRS) has been performed as treatment in selected cases, but the referral of patients has been severely influenced by the marked perioperative morbidity and mortality [8]. Less invasive techniques have been developed with the aim of improving patients' pulmonary function, symptoms, and quality of life (QoL) [9]. Among them, the one most commonly used is the endoscopic placement of one way endobronchial valves (EBV) [10-12]. So far patients with severe emphysema and established PH have been excluded from LVRS as well as from endoscopic lung volume reduction (ELVR) therapy.

Whether bronchoscopic lung volume reduction in COPD patients with silver nitrate or histoacryl influences the severity of PH in patients with severe emphysema and PH has yet to be elucidated.

This study is designed as a prospective pilot study, with the primary endpoint being changes in pulmonary hemodynamic parameters after ELVR in patients with severe emphysema.

Secondary endpoints will be changes in lung function parameters, exercise capacity, and QoL.

Materials and Methods This is Prospective descriptive study on 20 COPD Patients with predominant emphysema especially with heterogeneous and upper lobe predominance emphysema admitted in chest department at Kasr al Ainy Hospital. All patients will be on optimal medical treatment for COPD according to Global Initiative for Chronic Obstructive Lung Disease guidelines [13] All patients will be subjected to the following at base line.

  1. full history taking.
  2. full clinical examination.
  3. plain chest x ray.
  4. an electrocardiogram, High resolution computed tomography of the chest.
  5. Pulmonary function tests and ABG.
  6. 6-minute walk test.
  7. 2-D echocardiography at rest
  8. Right heart catheterization (RHC)
  9. Fiberoptic bronchoscopy with application of silver nitrate or histoacryl. The patients will be followed up every month by

1. Dyspnea score (using mMRC score) 2. 6-minute walk test. 3. ECG At 3rd Month 2-D echocardiography at rest will be done At 6th Month 2-D echocardiography at rest And RHC will be done .

Undersøgelsestype

Observationel

Tilmelding (Forventet)

20

Kontakter og lokationer

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Studiekontakt

Studiesteder

      • Cairo, Egypten, 14211
        • Rekruttering
        • Kasr Alaini School of Medicine
        • Ledende efterforsker:
          • Mostafa Elshazly, MD
        • Underforsker:
          • Mohamed Alnady, MD
        • Underforsker:
          • Karim Mahmoud, MD
        • Underforsker:
          • Ahmed Amer, MSc

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

30 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

COPD Patients with predominant emphysema especially with heterogeneous and upper lobe predominance emphysema

Beskrivelse

Inclusion Criteria:

  • COPD patients with predominant emphysema especially with heterogeneous and upper lobe predominance emphysema

Exclusion Criteria:

  1. Airflow limitation with FEV1 < 20%.
  2. Patients not candidate for FOB.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
change in mean Pulmonary artery pressure after ELVR
Tidsramme: 3months, 6monthes
Right heart cathetrization
3months, 6monthes

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dysnea Score
Tidsramme: 3 months,6months
using modified Medical Research Council (mMRC) criteria, with 0 representing dyspnea with strenuous exercise and 4 representing dyspnea with breathlessness when dressing
3 months,6months

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Studieleder: Mohamed A Elnady, MD, Professor of pulmonary Medicine ,Cairo University
  • Studieleder: Karim Mahmoud, MD, Lecturer of cardiology ,Cairo University

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 2016

Primær færdiggørelse (Forventet)

1. maj 2017

Studieafslutning (Forventet)

1. maj 2017

Datoer for studieregistrering

Først indsendt

14. maj 2016

Først indsendt, der opfyldte QC-kriterier

19. maj 2016

Først opslået (Skøn)

20. maj 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. januar 2017

Sidst verificeret

1. januar 2017

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Publication in peer reviewed Journal

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