Diaphragm Thickness by Ultrasonography in Neurological Disorders

NCT ID: NCT05324176

Last Updated: 2022-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-13
• Study Completion Date: 2022-05-13

Brief Summary

participants will be allocated into three groups, acute neuropathy (Guillain Barre Syndrome) group, neuromuscular junction disorder(myasthenia gravis ) group, and control group(people with neurological disorders not affecting the respiratory system.Ultrasonography is done on the diaphragm. The index test (ultrasound imaging of the diaphragm) is used. A high-resolution portable ultrasound machine is used, with a 7- to 13-MHz linear array transducer. Patients will be examined in the supine position. diaphragmatic thickness will is measured on both sides during a deep breath in inspiration and during expiration. objectives: primary outcome: to compare diaphragm thickness between the three examined groups. Secondary outcome: correlation between clinical scores and reference US values of diaphragm

Detailed Description

after IRB (institutional research board ) approval, of the faculty of medicine, Mansoura University, Egypt, written informed consent from all participants will be taken. participants will be allocated into three groups, acute neuropathy (Guillain Barre Syndrome) group, neuromuscular junction disorder(myasthenia gravis ) group, and control group(people with neurological disorders not affecting the respiratory system. inclusion group: age more than 18, both sexes. exclusion criteria: cardiopulmonary disease, chest trauma, diaphragmatic injury, body mass index more than 30. Any participant who shows respiratory dysfunction on doing arterial blood gases and pulmonary function tests will not be enrolled in the study. methods: Ultrasonography is done on the diaphragm. The index test (ultrasound imaging of the diaphragm) is used. A high-resolution portable ultrasound machine is used, with a 7- to 13-MHz linear array transducer. Patients will be examined in the supine position. diaphragmatic thickness will is measured on both sides during a deep breath in inspiration and during expiration. objectives: primary outcome: to compare diaphragm thickness between the three examined groups. Secondary outcome: correlation between clinical scores and reference US values of diaphragm

Conditions

Guillain-Barre Syndrome; Myasthenia Gravis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Gillian-Barre

Patients will be examined in the supine position. diaphragmatic thickness will is measured on both sides during a deep breath in inspiration and during expiration.

Group Type: ACTIVE_COMPARATOR

diaphragmatic ultrasound

Intervention Type: RADIATION

diaphragmatic thickness will be measured on both sides during a deep breath in inspiration and during expiration.

Myasthenia Gravis

Patients will be examined in the supine position. diaphragmatic thickness will is measured on both sides during a deep breath in inspiration and during expiration.

Group Type: ACTIVE_COMPARATOR

diaphragmatic ultrasound

Intervention Type: RADIATION

diaphragmatic thickness will be measured on both sides during a deep breath in inspiration and during expiration.

control

Patients hospitalized with neurological disorders without affection of the respiratory system.

Group Type: ACTIVE_COMPARATOR

diaphragmatic ultrasound

Intervention Type: RADIATION

diaphragmatic thickness will be measured on both sides during a deep breath in inspiration and during expiration.

Interventions

diaphragmatic ultrasound

diaphragmatic thickness will be measured on both sides during a deep breath in inspiration and during expiration.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• all adult patients admitted to the neurology department

Exclusion Criteria

• cardiopulmonary diseases
• chest trauma
• diaphragmatic diseases
• Body Mass Index (BMI) > 30

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aya M Zhran

Role: PRINCIPAL_INVESTIGATOR

Mansoura University Faculty of Medicine

Locations

Mansoura University Hospitals

Al Mansurah, Not in US Or Canada, Egypt

Countries

Egypt

Other Identifiers

MD.19.06.186.R1.R2

Identifier Type: -

Identifier Source: org_study_id