Spirometry ,diaphragmatic Ultrasound and Skeletal Muscle Mass in Patients with Chronic Obstructive Pulmonary Disease

NCT06634485 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: Ultrasound in COPD
• Study Type: observational
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

• The primary objective is to evaluate the use of diaphragmatic function and skeletal muscle mass by ultrasound as a tool to establish the diagnosis of COPD and assess the severity of the disease.
• The secondary objective is to compare diaphragmatic function, Skeletal muscle mass, and spirometry results in patients with COPD.

Conditions

COPD; Ultrasound Therapy; Complications

Keywords

COPD; Diaphragmatic Ultrasound; Spirometry; Skeletal Muscle Mass

Outcome Measures

Primary Outcomes (1)

• to study the correlation between diaphragmatic excursion and FEV1

  In the COPD group,The aim is to assess the correlation between diaphragmatic excursion and FEV1

  Day 1

Secondary Outcomes (1)

• correlation between diaphragmatic muscle function , skeletal muscle mass and duration of hospital stay

  Day 1

Study Arms (2)

control group

This group include healthy volunteers who aged ≥ 40 years .

Device: ultrasound, spirometry

study group

This include stable COPD Patients who will be diagnosed by GOLD 2024 and last excerbation ≥ 6weeks .

Device: ultrasound, spirometry

Interventions

ultrasound, spirometry DEVICE

Ultrasound assessment of 1. diaphragmatic excursion:-the probe will be angled medially ,cranially , and dorsally so that the ultrasound beam reaches the posterior third of the diaphragm, in B-mode.Then, then M-mode exploration line will be placed perpendicular to the diaphragmatic dome to obtain maximum excursion . 2. (Tdi) will be measured using a high-frequency linear probe (10 MHz) placed on (ZA).The probe will be angled perpendicular to the lateral chest wall and placed between the midaxillary and anterior axillary lines at the eighth or ninth intercostal space. 3. Quadricep\|rectus femoris muscle assessment will be done by placing the transducer perpendicular to the long axis of the thigh. * Spirometry:-will be performed thrice by experienced technicians at our pulmonary function laboratory. Patients will be asked to take a maximal inspiration and then to forcefully expel air for as long and as quickly as possible.

control group; study group

Eligibility Criteria

• Age: 41 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Two groups will be enrolled in the study; the first group will include healthy volunteers who aged ≥ 40 years\& the second group will include stable COPD Patients of the same age group

You may qualify if:

• Group A (control group):
• This group include healthy volunteers who aged ≥ 40 years .
• Group B (study group):
• This include stable COPD Patients who will be diagnosed by GOLD 2024 and last excerbation ≥ 6weeks .

You may not qualify if:

• Group A (control group):
• Patients with disorders that may affect diaphragmatic function as
• Musculoskeletal / neurological disorders
• diaphragmatic eventration \\ hiatus hernia
• morbid obesity
• recent thoracic/abdominal surgeries
• pregnancy; pleurodesis \\fibrothorax.
• Group B (study group):-
• Patients need for non- invasive ventilation.
• Patients with disorders that may affect diaphragmatic function as
• Musculoskeletal / neurological disorders
• diaphragmatic eventration \\ hiatus hernia
• morbid obesity
• recent thoracic/abdominal surgeries
• pregnancy; pleurodesis \\fibrothorax

Sponsors & Collaborators

• Assiut University: lead

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Ultrasonography; Spirometry

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System

Central Study Contacts

Safaa Mohamed Shazly, resident doctor

CONTACT

01228942380; drsafaashazly@gmail.com

Hoda Ahmed Makhlouf, professor

CONTACT

01001529442; hamakhlouf@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: October 10, 2024
• Study Start: October 10, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: October 10, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share