Evaluation of Diaphragm in Chronic Obstructive Pulmonary Disease Patients by Ultrasound in Relation to Severity
27. september 2021 opdateret af: Enas Sayed Farhat
Evaluation of Diaphragm in Chronic Obstructive Pulmonary Disease Patients Using Ultrasonography in Relation to Disease Severity in Fayoum University Hospital
The study of the diaphragm is an important point in the assessment of COPD patients.
Ultrasonographic evaluation of the diaphragm is considered a simple, non-invasive, available bedside technique. Ultrasonography can be used for evaluation of the site, structure, and motion of the diaphragm, assessment of excursion, and thickness.
The aim of the study is ultrasonographic assessment of the diaphragm in COPD patients and its relation to disease severity
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The study was conducted on eighty patients, forty COPD patients who were diagnosed and classified into four groups according as following: The first group: included 10 patients with a mild stage.
The second group: included 10 patients with a moderate stage.
The third group: included 10 patients with a severe stage.
The fourth group: included 10 patients with a very severe stage.
The study also included forty healthy individuals of the same age and sex as COPD patients.
All participants gave their informed consent for inclusion before sharing in the study.
Every person was submitted to: Full medical history, Clinical examination,Chest x-ray, spirometry and ultrasonographic assessment of diaphragm function (thickness and excursion)
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
80
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Fayoum, Egypten
- Fayoum University hospital
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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
40 år til 60 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Han
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
40 COPD patients and 40 age matched healthy control
Beskrivelse
Inclusion Criteria:
• Stable COPD patients aged more than 40 years who were diagnosed and classified into four groups of severity according to GOLD 2020.
- Age and sex-matched healthy controls
Exclusion Criteria:
• Patient with a known neuromuscular disorder.
- Patient with known anatomical malformation of the diaphragm.
- Post abdominal or thoracic surgery.
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 |
Intervention / Behandling |
|---|---|
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40 COPD patients
all participants were subjected to : history - clinical examination - spirometry - ultrasound evaluation of diaphragmatic function
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ultrasound assessment of diaphragm function
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40 healthy individuals
all participants were subjected to : history - clinical examination - spirometry - ultrasound evaluation of diaphragmatic function
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ultrasound assessment of diaphragm function
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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measure diaphragmatic thickness by ultrasound
Tidsramme: 1 year study
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measure diaphragmatic thickness at total lung capacity and residual volume in millimetres to calculate diaphragm thickness fraction
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1 year study
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measure diaphragm excursion by ultrasound
Tidsramme: 1 year study
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measure diaphragm excursion in centimetres at zone of apposition
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1 year study
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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spirometry assessment
Tidsramme: 1 year study
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value of forced expiratory volume in first second is assessed as a percentage of normal by spirometry to assess disease severity
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1 year study
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questionnaires
Tidsramme: 1 year study
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( modified medical research council and chronic obstructive pulmonary disease assessment test) to detect severity of the disease
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1 year study
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Enas S Farhat, MD, Fayoum University hospital
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)
14. december 2019
Primær færdiggørelse (Faktiske)
14. juni 2020
Studieafslutning (Faktiske)
14. december 2020
Datoer for studieregistrering
Først indsendt
3. september 2021
Først indsendt, der opfyldte QC-kriterier
3. september 2021
Først opslået (Faktiske)
5. september 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. september 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. september 2021
Sidst verificeret
1. september 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- M 448
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
after the submission is finished, the individual participant data will be shared to other researchers
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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