NCT05175313

Brief Summary

Evaluation of respiratory function is considered a crucial component in the assessment of patients with a wide range of respiratory diseases. Spirometry is considered a common method of measuring pulmonary function. Recently, Transthoracic ultrasound yields important diagnostic information within minutes. Respiratory muscle ultrasound is used to evaluate the anatomy and function of the respiratory system.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 3, 2022

Completed
12 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

5 months

First QC Date

December 14, 2021

Last Update Submit

April 10, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • investigate the correlation between transthoracic ultrasonography findings and their relation to spirometric indices in patients with different respiratory diseases.

    we will study the degree of change in lung ultrasound, diaphragm, and respiratory muscles ultrasound, inferior vena cava ultrasound in obstructive and restrictive respiratory diseases .also, we find their correlation with spirometric indices in these diseases.

    6months

Study Arms (3)

normal people

people who don't complain of respiratory diseases will be examined by chest ultrasound and pulmonary function test.

Radiation: transthoracic ultrasonographyDevice: spirometry

obstructive respiratory diseases

the patients who are diagnosed with either COPD or asthma.

Radiation: transthoracic ultrasonographyDevice: spirometry

restrictive respiratory diseases

patient with either ILD

Radiation: transthoracic ultrasonographyDevice: spirometry

Interventions

1. lung ultrasonography 2. Diaphragm and respiratory muscle ultrasound 3. inferior vena cava ultrasound

normal peopleobstructive respiratory diseasesrestrictive respiratory diseases

pulmonary function test : FVC, FEV1, FEV1/FVC will be measured.

normal peopleobstructive respiratory diseasesrestrictive respiratory diseases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

COPD: include patients with chronic bronchitis and emphysema. asthma: patients with paroxysmal attacks of chest tightness .wheezes and cough. ILD(interstitial lung diseases )

You may qualify if:

  • age \>18 years 2-patients diagnosed with COPD or asthma. 3-patients diagnosed with ILD or any other restrictive lung diseases. 4-normal people.

You may not qualify if:

  • age \<18 years old.
  • critically ill patients in intensive care units.
  • patients with neurological diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university hospital

Sohag, Egypt

RECRUITING

Related Publications (5)

  • Santana PV, Cardenas LZ, Albuquerque ALP, Carvalho CRR, Caruso P. Diaphragmatic ultrasound: a review of its methodological aspects and clinical uses. J Bras Pneumol. 2020 Nov 20;46(6):e20200064. doi: 10.36416/1806-3756/e20200064. eCollection 2020.

    PMID: 33237154BACKGROUND
  • Smargiassi A, Inchingolo R, Tagliaboschi L, Di Marco Berardino A, Valente S, Corbo GM. Ultrasonographic assessment of the diaphragm in chronic obstructive pulmonary disease patients: relationships with pulmonary function and the influence of body composition - a pilot study. Respiration. 2014;87(5):364-71. doi: 10.1159/000358564. Epub 2014 Apr 11.

    PMID: 24732295BACKGROUND
  • O'Hara DN, Pavlov A, Taub E, Ahmad S. Ultrasonographic modeling of diaphragm function: A novel approach to respiratory assessment. PLoS One. 2020 Mar 12;15(3):e0229972. doi: 10.1371/journal.pone.0229972. eCollection 2020.

    PMID: 32163474BACKGROUND
  • Santana PV, Cardenas LZ, de Albuquerque ALP, de Carvalho CRR, Caruso P. Diaphragmatic ultrasound findings correlate with dyspnea, exercise tolerance, health-related quality of life and lung function in patients with fibrotic interstitial lung disease. BMC Pulm Med. 2019 Oct 21;19(1):183. doi: 10.1186/s12890-019-0936-1.

    PMID: 31638951BACKGROUND
  • Zanforlin A, Giannuzzi R, Nardini S, Testa A, Soldati G, Copetti R, Marchetti G, Valente S, Inchingolo R, Smargiassi A. The role of chest ultrasonography in the management of respiratory diseases: document I. Multidiscip Respir Med. 2013 Aug 9;8(1):54. doi: 10.1186/2049-6958-8-54.

    PMID: 23937880BACKGROUND

MeSH Terms

Conditions

Respiratory Tract Diseases

Interventions

Spirometry

Intervention Hierarchy (Ancestors)

Respiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

esraa F Abdelaal, assistant lecturer

CONTACT

Kamal A Atta, professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

December 14, 2021

First Posted

January 3, 2022

Study Start

January 1, 2023

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

April 12, 2023

Record last verified: 2023-04

Locations