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Diaphragm Thickness by Ultrasonography in Neurological Disorders

Primary Purpose

Guillain-Barre Syndrome, Myasthenia Gravis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
diaphragmatic ultrasound
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Guillain-Barre Syndrome focused on measuring diaphragm thickness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • all adult patients admitted to the neurology department

Exclusion Criteria:

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

Sites / Locations

  • Mansoura University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Gillian-Barre

Myasthenia Gravis

control

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

diaphragm thickness
will be reported in (mm)

Secondary Outcome Measures

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"

Full Information

First Posted
April 4, 2022
Last Updated
May 13, 2022
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05324176
Brief Title
Diaphragm Thickness by Ultrasonography in Neurological Disorders
Official Title
Assessment of Diaphragm Thickness by Ultrasonography in Guillain Barre Syndrome and Myasthenia Gravis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 13, 2022 (Actual)
Primary Completion Date
May 9, 2022 (Actual)
Study Completion Date
May 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Guillain-Barre Syndrome, Myasthenia Gravis
Keywords
diaphragm thickness

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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 in the 3 groups: (1) Gillian-Barre syndrome; (2) Myasthenia Gravis; (3) control
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gillian-Barre
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Myasthenia Gravis
Arm Type
Active Comparator
Arm Description
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.
Arm Title
control
Arm Type
Active Comparator
Arm Description
Patients hospitalized with neurological disorders without affection of the respiratory system.
Intervention Type
Radiation
Intervention Name(s)
diaphragmatic ultrasound
Intervention Description
diaphragmatic thickness will be measured on both sides during a deep breath in inspiration and during expiration.
Primary Outcome Measure Information:
Title
diaphragm thickness
Description
will be reported in (mm)
Time Frame
within 24 hours from hospital admission
Secondary Outcome Measure Information:
Title
Hughes clinical score
Description
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"
Time Frame
within 24 hours from hospital admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aya M Zhran
Organizational Affiliation
Mansoura University Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura University Hospitals
City
Mansoura
State/Province
Not In US Or Canada
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Diaphragm Thickness by Ultrasonography in Neurological Disorders

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