Diaphragm Thickness by Ultrasonography in Neurological Disorders

Myasthenia Gravis Clinical Trial

Official title:

Assessment of Diaphragm Thickness by Ultrasonography in Guillain Barre Syndrome and Myasthenia Gravis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05324176
• Other study ID #: MD.19.06.186.R1.R2
• Status: Completed
• Phase: N/A
• Start date: April 13, 2022
• Est. completion date: May 13, 2022

Study information

• Verified date: May 2022
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 13, 2022
• Est. primary completion date: May 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all adult patients admitted to the neurology department

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Guillain-Barre Syndrome
• Myasthenia Gravis
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Egypt	Mansoura University Hospitals	Mansoura	Not In US Or Canada

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diaphragm thickness	will be reported in (mm)	within 24 hours from hospital admission
Secondary	Hughes clinical score	score of disability 1-5, "Hughes RA, Newsom-Davis JM, Perkin GD, Pierce JM.Controlled trial prednisolone in acute polyneuropathy.Lancet. 1978;2:750-3"	within 24 hours from hospital admission