Early Prediction of Respiratory and Autonomic Complications of GBS Using Neuromuscular Ultrasound

NCT04166357 | Unknown

• 1 other identifier: Mansoura University Hospital 5
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Neuromuscular US will be a good and non invasive predictor for respiratory and autonomic dysfunctions in GBS through evaluation of diaphragmatic thickness, phrenic and vagus nerve cross sectional area.

Conditions

Guillain Barre Syndrome

Keywords

Guillain Barre Syndrome, neuromuscular ultrasound

Outcome Measures

Primary Outcomes (1)

• Neuromuscular ultrasound

  Sensitivity and specificity of US in predicting respiratory and autonomic complications in Guillain Barre Syndrome

  24-48 hours

Secondary Outcomes (2)

• Respiratory and autonomic complications

  1 month

• Correlation between clinical scores and reference US values

  48-72 hours

Study Arms (1)

Respiratory and autonomic complications of GBS

Early detection of respiratory failure is among the main challenges raised by the management of GBS. Careful monitoring by an experienced team of nurses and physicians is crucial. The classic signs of respiratory failure occur late, and the early manifestations consist only of tachypnea, tachycardia, air hunger, broken sentences, and a need to pause between sentences; later, use of the accessory respiratory muscles, paradoxical breathing, and orthopnea indicate severe diaphragmatic weakness. Autonomic dysfunction occurred in the affected patients, including cardiac arrhythmia, hypertension or hypotension, ileus, and urinary retention.

Diagnostic Test: neuromuscular ultrasound

Interventions

neuromuscular ultrasound DIAGNOSTIC_TEST

Neuromuscular ultrasound refers to a field in medicine in which ultrasound is used to diagnosis and guide treatment for people with neuromuscular diseases. Neuromuscular ultrasound is often combined with electrodiagnosis, and particularly nerve conduction studies and EMG, to improve the accuracy of diagnosis and add anatomic information to the functional information obtained with electrodiagnosis. It has been demonstrated that neuromuscular ultrasound adds value to the diagnosis of nerve disease in over 80% of cases.

Respiratory and autonomic complications of GBS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

100 Patients that will fulfill the published diagnostic criteria of GBS.

You may qualify if:

• Patients that will fulfill the published diagnostic criteria of GBS.
• Age: 18-65
• Both sexes

You may not qualify if:

• History of cardiopulmonary dysfunction
• BMI\>30 Kg/m2
• Renal or hepatic failure
• Sepsis
• Autonomic or respiratory dysfunction from the start
• Patients with hypo- or hyperkalemic paralysis, porphyria, viral myositis, botulism, diphtheritic neuropathy, and history of potential toxic exposure were excluded.
• Abnormal pulmonary function test from the start.

Sponsors & Collaborators

• Mansoura University Hospital: lead

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Egypt

RECRUITING

MeSH Terms

Conditions

Guillain-Barre Syndrome

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Esmael M Ahmed, MD

  Assistant Prof of Neurology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esmael M Ahmed, MD

CONTACT

00201000372787; deltaneuro@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof of Neurology

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 18, 2019
• Study Start: July 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: November 1, 2020
• Last Updated: November 18, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)