- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02763709
Evaluation of Pediatric Critical Illness Neuropathy/Myopathy in Pediatric Intensive Care Unit
Study Overview
Status
Conditions
Detailed Description
Materials and Methods
Study Setting: Pediatric Intensive Care Unit, Advanced Pediatric Centre, Postgraduate Institute of Medical Educational Research
Study Period: Jan 2016 to Dec 2016
Study design: Prospective Cohort Study
Study Population: Children of 2 years to 12 years of age
Study flow
All consecutive patients between the age group 2 years to 12 years admitted in Pediatric Intensive Care Unit (ICU) in Advanced pediatric Centre with PRISM score of more than 20 will screened for inclusion in the study.Those found eligible would be included after an informed consent. Baseline clinical and demographic profile will be recorded on a proforma.
Entry Examination
Clinical Evaluation
It would include history and examination. A clinical evaluation will be performed at the time of patient recruitment and then daily till discharge from ICU. It would also include assessment of the Glasgow Coma Scale, the Sequential Organ System Failure score (SOFA) and tendon reflexes. The muscle strength of the main muscle groups will be graded using the Medical Research Council (MRC) scale in cooperative children.
- Upper Extremity: Wrist Extension, Elbow Flexion, Shoulder Abduction
- Lower Extremity: Ankle Dorsiflexion, Knee Extension, Hip Flexion
Scoring & Interpretation:
- Maximum Score: 60 (4 Limbs, Maximum of 15 Points Per Limb) = Normal
- Minimum Score: 0 = Quadriplegia
Severity of multi organ failure will be assessed by mean SOFA scores during ICU stay, highest SOFA scores and sum of 28-day total SOFA scores in every patient.
The total dose and duration of drug therapy like steroids, muscle relaxants, sedatives and inotropes will also be entered. Laboratory parameters like serum creatine kinase, albumin, total protein, serum electrolytes and plasma blood glucose will also quantified.
Electrophysiological Evaluation
Twenty fours after admission, entry examination in the form of complete nerve conduction study from 4 motor nerves (median, ulnar, tibial and common peroneal nerve) and 2 sensory nerves (median and sural nerve) will be performed. These will consist of Compound Motor Action Potential(CMAP) measurement from motor nerves and Sensory Nerve Action Potential (SNAP) assessment from sensory nerves. Before the electrophysiological tests, heat packs will be applied to the skin if its temperature is below 33°C.
Serial Examination
Following the detailed entry evaluation, daily simplified electrophysiological tests in the form of conduction velocity and amplitude of the sural SNAP and common peroneal CMAP in one leg using surface electrode stimulation and recording electrodes will be assessed. To minimize artifacts, the same electrode site will be marked and similar size electrode will be used for each patient on a daily basis. A 25% decrease from baseline SNAP and CMAP measured at ICU admission will be taken as the minimum consistently detectable reduction.If SNAP or CMAP decreases by more than 25% on two consecutive days, a complete electrophysiological test will be performed. Complete electrophysiological testing includes nerve conduction study and electromyography.Electromyography will be recorded using a coaxial needle electrode in the tibialis anterior and first dorsal interossei.If the complete electrophysiological test is consistent with critical illness weakness, complete weekly tests will replace daily tests until ICU discharge.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Ananthanarayanan K, MD
- Phone Number: 09814393609
- Email: cerebratelife@gmail.com
Study Locations
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Chandigarh, India, 160012
- Recruiting
- PGIMER
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Contact:
- Naveen Sankhyan, MD DM
- Email: drnsankhyan@yahoo.co.in
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Contact:
- Pratibha Singhi, MD
- Email: doctorpratibhasinghi@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children admitted in Pediatric Intensive Care Unit for more than 24 hours
- Pediatric Risk of Mortality (PRISM) score III > 20
Exclusion Criteria:
- Previous (Eg: Diabetes Mellitus, Systemic Lupus Erythematosus, Dermatomyositis, Spinal Muscular Atrophy) or current neuromuscular disorder (e.g Guillian Barre Syndrome, snake bite, myositis)
- Use of drugs causing neuromuscular blockade
- Bilateral Lower limb disorders precluding Nerve Conduction Study or ElectroMyoGraphy (Gross edema, fractures, amputation, plaster casts, open wounds, infections)
- Children with abnormal electrophysiological studies at baseline examination will be excluded
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Cases
Children admitted in Pediatric ICU for more than 24 hours with Pediatric Risk of Mortality (PRISM) score III > 20
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of Pediatric critical illness polyneuropathy/myopathy
Time Frame: 1 month
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1 month
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Collaborators and Investigators
Investigators
- Principal Investigator: Naveen Sankhyan, DM, Postgraduate Institute of Medical Education and Research
- Principal Investigator: Pratibha Singhi, MD, Postgraduate Institute of Medical Education and Research
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEDCIMP2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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