Assessment of Right Ventricular Function Among Children With Chronic Lung Disease

NCT06134947 | Unknown

• 1 other identifier: Right Ventricular Function in
• Study Type: observational
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Pediatric Chronic lung disease (CLD) is an abroad term that encompasses a heterogeneous group of different clinicopathological disorders that advance slowly over months or years. They can broadly be divided into two groups: those with a known cause and those without. Cystic fibrosis, broncho-pulmonary dysplasia or lung of prematurity, asthma, chronic gastro esophageal reflux/aspiration pneumonitis, and constrictive obliterative bronchiolitis, chronic infection, and hypersensitivity pneumonitis are all included in the first group. The second group is subdivided into primary pulmonary diseases (idiopathic interstitial pneumonia, persistent tachypnea of infancy associated with neuroendocrine cell hyperplasia, pulmonary lymphatic and vascular disorders, etc.) and systemic diseases with a pulmonary manifestation (e.g., Langerhans cell histio- cytosis, vasculities, and granulomatosis) Asthma is a chronic inflammatory disease of the airways which is related to airway obstruction, hyper responsiveness and characterized recurrent wheezing, coughing and breathlessness Asthma, recurrent hypoxemia, and hypercarbia, together with various mediators and cytokines released due to chronic inflammation, lead to pulmonary vasoconstriction Exaggerated respiratory efforts in asthmatic patients may increase intrathoracic pressure, which may increase right-ventricular (RV) afterload. Consequently, pulmonary hypertension may develop, which could then lead to RV hypertrophy and/or dilatation There are lacks of information's about right ventricular (RV) function in children with chronic lung diseases so in this study the RV systolic function will be evaluated. Systolic right ventricular (RV) function is an important predictor in the course of heart disease such as in pulmonary hypertension .The European Society of Cardiology and the American Society of Echocardiography recommend the use of tissue Doppler imaging for the evaluation of both diastolic and systolic functions .

Conditions

Right Ventricular Function

Keywords

chronic lung disease

Outcome Measures

Primary Outcomes (1)

• Right ventricular function evaluation among children with chronic Lung disease

  Right ventricular function evaluation among children with chronic Lung disease through tricuspid annular peak systolic excursion (TAPSE) and tricuspid annular peak systolic velocity (TAPSV) by tissue Doppler

  1 year

Study Arms (2)

Group A

group A=75 patients as case group (children with Chronic Respiratory Disease)

Other: Echocardiographic examination

Group B

group B=75 children as control group (children with no Chronic Respiratory Disease).

Other: Echocardiographic examination

Interventions

Echocardiographic examination OTHER

Standard 2D echocardiographic evaluation of right ventricle systolic function will be performed as follows: * Tricuspid annular peak systolic excursion (TAPSE) will be measured by placing M- mode cursor through tricuspid annulus and measuring the amount of longitudinal motion of the annulus at the peak systole in the longitudinal apical 4chamber view, TAPSE \<-2 Z Score is considered abnormal . * Tricuspid annular peak systolic velocity (TAPSV) by tissue Doppler \<-2 Z Score is considered abnormal. Through Tissue Doppler Imaging values of right ventricle will be obtained from the apical four -chamber view using a sample volume placed at the lateral corner of the tricuspid annulus. Peak systolic annular velocity (Ś).

Also known as: Echo Doppler study for right ventricular function

Group A; Group B

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Sample Size Calculation: The sample size will be determined using epi-infoVersion 7 based on the following prerequisites: * Confidence level = 95% * Expected frequency of Chronic Respiratory Disease = 4.9%. * Confidence limit =5% * Population size = 10000. * Sample size (n) =75 patients as case group A total of seventy - five participants will be selected to be included at the study (group A=75 patients as case group (children with Chronic Respiratory Disease) , group B=75 children as control group (children with no Chronic Respiratory Disease). Including: 31 patients with bronchial asthma. 22 patients with interstitial pulmonary fibrosis. 22 patients with cystic fibrosis.

You may qualify if:

• Children have aged from 7 years to 18 years.
• Patients diagnosed with chronic lung disease at pediatric pulmonology unit by chest radiograph, computerized topography (CT) chest finding, sweat chloride test and pulmonary function tests.
• A total of seventy - five participants will be selected to be included at the study (group A=75 patients as case group (children with Chronic Respiratory Disease) , group B=75 children as control group (children with no Chronic Respiratory Disease).
• Including:
• patients with bronchial asthma. 22 patients with interstitial pulmonary fibrosis. 22 patients with cystic fibrosis.

You may not qualify if:

• Congenital heart disease and Acquired heart diseases.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (9)

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  PMID: 19270053 BACKGROUND

• Patel N, Massolo AC, Kipfmueller F. Congenital diaphragmatic hernia-associated cardiac dysfunction. Semin Perinatol. 2020 Feb;44(1):151168. doi: 10.1053/j.semperi.2019.07.007. Epub 2019 Jul 30.

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  PMID: 8689654 BACKGROUND

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  PMID: 21448272 BACKGROUND

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• Koestenberger M, Ravekes W, Everett AD, Stueger HP, Heinzl B, Gamillscheg A, Cvirn G, Boysen A, Fandl A, Nagel B. Right ventricular function in infants, children and adolescents: reference values of the tricuspid annular plane systolic excursion (TAPSE) in 640 healthy patients and calculation of z score values. J Am Soc Echocardiogr. 2009 Jun;22(6):715-9. doi: 10.1016/j.echo.2009.03.026. Epub 2009 May 7.

  PMID: 19423286 BACKGROUND

MeSH Terms

Interventions

Ventricular Function, Right

Intervention Hierarchy (Ancestors)

Ventricular Function; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Mohamed Abdel-Hamed, as

CONTACT

+201027088385; dr1khalaf@gmail.com

Ghada Mahmoud, prof

CONTACT

+201111985154

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr

Study Record Dates

• First Submitted: November 5, 2023
• First Posted: November 18, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11