NCT05324176

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

April 13, 2022

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2022

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2022

Completed
Last Updated

May 16, 2022

Status Verified

May 1, 2022

Enrollment Period

26 days

First QC Date

April 4, 2022

Last Update Submit

May 13, 2022

Conditions

Keywords

diaphragm thickness

Outcome Measures

Primary Outcomes (1)

  • diaphragm thickness

    will be reported in (mm)

    within 24 hours from hospital admission

Secondary Outcomes (1)

  • Hughes clinical score

    within 24 hours from hospital admission

Study Arms (3)

Gillian-Barre

ACTIVE COMPARATOR

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

Myasthenia Gravis

ACTIVE COMPARATOR

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

control

ACTIVE COMPARATOR

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

Radiation: diaphragmatic ultrasound

Interventions

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

Gillian-BarreMyasthenia Graviscontrol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all adult patients admitted to the neurology department

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Hospitals

Al Mansurah, Not in US Or Canada, 35516, Egypt

Location

MeSH Terms

Conditions

Guillain-Barre SyndromeMyasthenia Gravis

Condition Hierarchy (Ancestors)

PolyradiculoneuropathyAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsParaneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesNeurodegenerative DiseasesNeuromuscular Junction Diseases

Study Officials

  • Aya M Zhran

    Mansoura University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2022

First Posted

April 12, 2022

Study Start

April 13, 2022

Primary Completion

May 9, 2022

Study Completion

May 13, 2022

Last Updated

May 16, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

Anonymous patients' data will be available with the PI or corresponding Author on reasonable request according to local IRB regulations

Time Frame
will be reported
Access Criteria
will be reported

Locations