Guillain Barre SyndromeNCT04166357
Early Prediction of Respiratory and Autonomic Complications of GBS Using Neuromuscular Ultrasound
An observational study of Guillain Barre Syndrome, run by Mansoura University Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Guillain Barre Syndrome
- What is being tested?
- neuromuscular ultrasound
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2019to 1 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 Patients that will fulfill the published diagnostic criteria of GBS.
Who may be able to join
- Patients that will fulfill the published diagnostic criteria of GBS.
- Age: 18-65
- Both sexes
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University Hospital
Al Mansurah
Esmael M Ahmed, MD, 00201000382898, deltaneuro@yahoo.com
About this study
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.
Read the detailed description
Patients presented in the ER with clinical manifestations and examination suggesting GBS are admitted to neurology department. Confirmation of the diagnosis of GBS is done by fulfilling the clinical diagnostic criteria, CSF examination is done searching for cytoalbuminous dissociation ,serum electrolytes, toxicological screening ,virology to exclude mimics of GBS.
Patients will undergo electrophysiological study (motor NCS of both median ulnar ,tibial ,and peroneal nerves ). Distal motor latency (dmL), nerve conduction velocity (CV) and compound muscle action potential (CMAP)amplitude measurements were undertaken as well as measurements of the mean F-M-latencies of both median ,ulnar and tibial nerves (F-wave latency-dmL). Similarly, sensory nerve conduction study is applied on both median and ulnar nerves ,(dml is assessed. According to the electophysiological study results, patients will be grouped into:
- AIDP: If two or more nerves showed demyelinating features (distal latency prolongation, slow nerve conduction velocity, conduction block, or prolonged F wave latency) on motor nerve conduction study.
- AMAN: Normal sensory conduction studies and unrecordable or reduced compound muscle action potential on motor nerve conduction study. There should not be more than one demyelinating feature in any nerve.
- AMSAN: If both motor and sensory nerve conduction studies revealed features of axonal neuropathy such as reduced or absent CMAP and SNAP, marginal slowing or normal conduction velocity and absence of conduction block.
- Inexcitable: Absent CMAP in all motor nerves (or present in only one nerve with CMAP <10%of lower limit of normal).
- Equivocal: GBS patients not fulfilling the above neurophysiologic criteria.
Then patients will be assessed clinically using the Medical Research Council (MRC) grading for power and Hughes functional grading scale scores.
Muscle groups (right and left) assessed in the measurement of the MRC sums core are:
- Abduction of the arm
- Flexion of the forearm
- Extension of the wrist
- Flexion of the leg
- Extension of the knee
- Dorsal flexion of the foot 0 = No visible contraction
- = Visible contraction without movement of the limb
- = Movement of the limb but not against gravity
- = Movement against gravity over (almost) the full range
- = Movement against gravity and resistance
- = Normal The MRC-sums core ranges from 0 (paralytic) to 60 (normal strength). (Kleyweg RP et al.,1988)
Guillain-Barré syndrome disability scale 0 A healthy state
- Minor symptoms and capable of running
- Able to walk 10 m or more without assistance but unable to run
- Able to walk 10 m across an open space with help
- Bedridden or chair bound
- Requiring assisted ventilation for at least part of the day
- Dead
Basal and every day arterial blood gases unless new respiratory event occurs. Basal pulmonary function test is done. Clinical assessment for autonomic dysfunction: In addition to reported or clinically evaluated symptoms (sweating problems, orthostatic dysregulation, sexual dysfunction). ECG is done day after day and blood pressure measurements five times daily for at least the first seven days of acute hospitalization.
Ultrasonography is done on diaphragm, phrenic nerve and vagus nerve. As regard diaphragmatic ultrasound:
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. The diaphragm was identified as a 3-layered structure lying deep to the intercostals muscles and subcutaneous tissue. 3 images captured at end-expiration and 3 images captured after the patient is asked to inhale as deeply as possible. The transducer is positioned in a sagittal oblique plane, spanning 2 ribs, at approximately the anterior axillary line, overlying one of the most caudal intercostal spaces. Measurements of diaphragm thickness are made using electronic calipers, and the 3 images for each position are then averaged to give a thickness at resting end-expiration (TMIN) and at maximal inspiration (TMAX), from which a diaphragm thickening ratio is derived: TMAX/TMIN. Normal diaphragm thickness is defined as ≥0.14 cm and the normal diaphragm thickening ratio is defined as ≥1.2.
As regard phrenic nerve US:
Under the guidance of a high resolution ultrasound with the patient's head towards the left, the ultrasound probe (frequency, 7-13MHz) was placed on the right side of the neck. The axial scanning of the neck along the surface of the anterior scalene muscle, showed that the phrenic nerve rounded the anterior scalene muscle from the outside to the inside, and coursed through the trench between the common carotid artery and anterior scalene muscle.
As regard vagus us:
All participants were examined with HRUS by a(7-12) MHz transducer. Each VN was visualized in the axial plane at the level of the thyroid gland, and three images were recorded at each side. To assess the VN-CSA its contour within the hyperechoic epineural rim was outlined.. The median of the three VN-CSA measurements was used for statistical analyses.
Patients then undergo plasmapharesis 50 mL/kg, on 5 separate occasions over 1-2 weeks.
Patients after that are evaluated again (4 weeks from the onset of the condition)ie at the end of the acute stage of Guillan Barre syndrome by MRC and Hughes clinical scores and clinical evaluation of autonomic and respiratory dysfunctions will be also assessed . Ultrasound will be done on diaphragm, phrenic nerve and vagus nerve again.
- Conditions
- Guillain Barre Syndrome
- Being tested
- neuromuscular ultrasound
- Keywords
- Guillain Barre Syndrome, neuromuscular ultrasound
- Medical subject headings
- Guillain-Barre Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuromuscular ultrasoundDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: neuromuscular ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuromuscular ultrasound
Sensitivity and specificity of US in predicting respiratory and autonomic complications in Guillain Barre Syndrome
Measured: 24-48 hours
Secondary outcomes (2)
Respiratory and autonomic complications
Incidence of cases developing respiratory and autonomic complications through the course of the disease.
Measured: 1 month
Correlation between clinical scores and reference US values
Correlation between clinical scores and reference US values of diaphragm, phrenic and vagus nerves in prediction of respiratory and autonomic complications of Guillain Barre Syndrome
Measured: 48-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start1 Jul 2019
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guillain Barre SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Esmael, Mansoura University Hospital
- Investigators
- Esmael M Ahmed, MD, Principal investigator, Assistant Prof of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166357
- Sponsor's protocol ID
- Mansoura University Hospital 5
- Status last verified
- Nov 2019
- First submitted
- 12 Nov 2019
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Prediction of Respiratory and Autonomic Complications of GBS Using Neuromuscular Ultrasound
- ClinicalTrials.gov ID
- NCT04166357
- Acronym / sponsor ID
- Mansoura University Hospital 5
- Conditions
- Guillain Barre Syndrome
- Keywords
- Guillain Barre Syndrome, neuromuscular ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mansoura University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients presented in the ER with clinical manifestations and examination suggesting GBS are admitted to neurology department. Confirmation of the diagnosis of GBS is done by fulfilling the clinical diagnostic criteria, CSF examination is done searching for cytoalbuminous dissociation ,serum electrolytes, toxicological screening ,virology to exclude mimics of GBS.
Patients will undergo electrophysiological study (motor NCS of both median ulnar ,tibial ,and peroneal nerves ). Distal motor latency (dmL), nerve conduction velocity (CV) and compound muscle action potential (CMAP)amplitude measurements were undertaken as well as measurements of the mean F-M-latencies of both median ,ulnar and tibial nerves (F-wave latency-dmL). Similarly, sensory nerve conduction study is applied on both median and ulnar nerves ,(dml is assessed. According to the electophysiological study results, patients will be grouped into:
- AIDP: If two or more nerves showed demyelinating features (distal latency prolongation, slow nerve conduction velocity, conduction block, or prolonged F wave latency) on motor nerve conduction study.
- AMAN: Normal sensory conduction studies and unrecordable or reduced compound muscle action potential on motor nerve conduction study. There should not be more than one demyelinating feature in any nerve.
- AMSAN: If both motor and sensory nerve conduction studies revealed features of axonal neuropathy such as reduced or absent CMAP and SNAP, marginal slowing or normal conduction velocity and absence of conduction block.
- Inexcitable: Absent CMAP in all motor nerves (or present in only one nerve with CMAP <10%of lower limit of normal).
- Equivocal: GBS patients not fulfilling the above neurophysiologic criteria.
Then patients will be assessed clinically using the Medical Research Council (MRC) grading for power and Hughes functional grading scale scores.
Muscle groups (right and left) assessed in the measurement of the MRC sums core are:
- Abduction of the arm
- Flexion of the forearm
- Extension of the wrist
- Flexion of the leg
- Extension of the knee
- Dorsal flexion of the foot 0 = No visible contraction
- = Visible contraction without movement of the limb
- = Movement of the limb but not against gravity
- = Movement against gravity over (almost) the full range
- = Movement against gravity and resistance
- = Normal The MRC-sums core ranges from 0 (paralytic) to 60 (normal strength). (Kleyweg RP et al.,1988)
Guillain-Barré syndrome disability scale 0 A healthy state
- Minor symptoms and capable of running
- Able to walk 10 m or more without assistance but unable to run
- Able to walk 10 m across an open space with help
- Bedridden or chair bound
- Requiring assisted ventilation for at least part of the day
- Dead
Basal and every day arterial blood gases unless new respiratory event occurs. Basal pulmonary function test is done. Clinical assessment for autonomic dysfunction: In addition to reported or clinically evaluated symptoms (sweating problems, orthostatic dysregulation, sexual dysfunction). ECG is done day after day and blood pressure measurements five times daily for at least the first seven days of acute hospitalization.
Ultrasonography is done on diaphragm, phrenic nerve and vagus nerve. As regard diaphragmatic ultrasound:
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. The diaphragm was identified as a 3-layered structure lying deep to the intercostals muscles and subcutaneous tissue. 3 images captured at end-expiration and 3 images captured after the patient is asked to inhale as deeply as possible. The transducer is positioned in a sagittal oblique plane, spanning 2 ribs, at approximately the anterior axillary line, overlying one of the most caudal intercostal spaces. Measurements of diaphragm thickness are made using electronic calipers, and the 3 images for each position are then averaged to give a thickness at resting end-expiration (TMIN) and at maximal inspiration (TMAX), from which a diaphragm thickening ratio is derived: TMAX/TMIN. Normal diaphragm thickness is defined as ≥0.14 cm and the normal diaphragm thickening ratio is defined as ≥1.2.
As regard phrenic nerve US:
Under the guidance of a high resolution ultrasound with the patient's head towards the left, the ultrasound probe (frequency, 7-13MHz) was placed on the right side of the neck. The axial scanning of the neck along the surface of the anterior scalene muscle, showed that the phrenic nerve rounded the anterior scalene muscle from the outside to the inside, and coursed through the trench between the common carotid artery and anterior scalene muscle.
As regard vagus us:
All participants were examined with HRUS by a(7-12) MHz transducer. Each VN was visualized in the axial plane at the level of the thyroid gland, and three images were recorded at each side. To assess the VN-CSA its contour within the hyperechoic epineural rim was outlined.. The median of the three VN-CSA measurements was used for statistical analyses.
Patients then undergo plasmapharesis 50 mL/kg, on 5 separate occasions over 1-2 weeks.
Patients after that are evaluated again (4 weeks from the onset of the condition)ie at the end of the acute stage of Guillan Barre syndrome by MRC and Hughes clinical scores and clinical evaluation of autonomic and respiratory dysfunctions will be also assessed . Ultrasound will be done on diaphragm, phrenic nerve and vagus nerve again.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respiratory and autonomic complications of GBS | – | Diagnostic Test: neuromuscular ultrasoundEarly 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 Patients that will fulfill the published diagnostic criteria of GBS.
Key inclusion criteria (3 listed)
- Patients that will fulfill the published diagnostic criteria of GBS.
- Age: 18-65
- Both sexes
Key exclusion criteria (7 listed)
- History of cardiopulmonary dysfunction
- BMI>30 Kg/m2
- Renal or hepatic failure
- Sepsis
- Autonomic or respiratory dysfunction from the start
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neuromuscular ultrasoundNeuromuscular 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. | Diagnostic test | Respiratory and autonomic complications of GBS |
Primary outcome
Neuromuscular ultrasound
Time frame: 24-48 hours
Sensitivity and specificity of US in predicting respiratory and autonomic complications in Guillain Barre Syndrome
2 secondary outcomes
Respiratory and autonomic complications
Time frame: 1 month
Correlation between clinical scores and reference US values
Time frame: 48-72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Individual participant dataSharing planned: No
Related trials for Guillain Barre Syndrome
Recruiting
High-Tech Rehabilitation Pathway for Acute Adult Neuromuscular Diseases - Fit4MedRob-Acute MND Project
Critical Illness Myopathy, Guillain Barré Syndrome
Not yet recruitingPhase 2
A Study of Empasiprubart as Add-On Therapy to IVIg in Adult Participants With Guillain-Barré Syndrome
Guillain-Barré Syndrome (GBS)
RecruitingPhase 3
An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (FORWARD Study)
Guillain-Barre Syndrome
Not yet recruitingObservational study
Peripheral Nerve Ultrasound in Children With Guillain-Barré Syndrome
Guillain-Barre Syndrome
RecruitingObservational study
Early vs. Late Tracheostomy in Patients With Guillain -Barre Syndrome
Guillain Barre Syndrome, Mechanical Ventilation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esmael M Ahmed, MD principal investigator
Assistant Prof of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Guillain Barre Syndrome, run by Mansoura University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esmael M Ahmed, MD (00201000372787, deltaneuro@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuromuscular ultrasound (time frame: 24-48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.