Diaphragm Thickness by Ultrasonography in Neurological Disorders

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

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

Study Overview

• Status: Completed
• Conditions: Myasthenia Gravis; Guillain-Barre Syndrome
• Intervention / Treatment: Radiation: diaphragmatic ultrasound

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Not In US Or Canada
    • Mansoura, Not In US Or Canada, Egypt, 35516
      • Mansoura University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• all adult patients admitted to the neurology department

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Radiation: diaphragmatic ultrasound; diaphragmatic thickness will be measured on both sides during a deep breath in inspiration and during expiration.
ACTIVE_COMPARATOR: 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.	Radiation: diaphragmatic ultrasound; diaphragmatic thickness will be measured on both sides during a deep breath in inspiration and during expiration.
ACTIVE_COMPARATOR: control; Patients hospitalized with neurological disorders without affection of the respiratory system.	Radiation: diaphragmatic ultrasound; diaphragmatic thickness will be measured on both sides during a deep breath in inspiration and during expiration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diaphragm thickness	will be reported in (mm)	within 24 hours from hospital admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Aya M Zhran, Mansoura University Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 13, 2022
• Primary Completion (ACTUAL): May 9, 2022
• Study Completion (ACTUAL): May 13, 2022

Study Registration Dates

• First Submitted: April 4, 2022
• First Submitted That Met QC Criteria: April 4, 2022
• First Posted (ACTUAL): April 12, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 16, 2022
• Last Update Submitted That Met QC Criteria: May 13, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: diaphragm thickness
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Neoplasms; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neoplasms by Site; Disease; Neuromuscular Diseases; Neurodegenerative Diseases; Peripheral Nervous System Diseases; Nervous System Neoplasms; Paraneoplastic Syndromes, Nervous System; Paraneoplastic Syndromes; Neuromuscular Junction Diseases; Polyradiculoneuropathy; Polyneuropathies; Syndrome; Myasthenia Gravis; Guillain-Barre Syndrome
• Other Study ID Numbers: MD.19.06.186.R1.R2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymous patients' data will be available with the PI or corresponding Author on reasonable request according to local IRB regulations
• IPD Sharing Time Frame: will be reported
• IPD Sharing Access Criteria: will be reported

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No