Evaluation of Pediatric Critical Illness Neuropathy/Myopathy in Pediatric Intensive Care Unit
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|ClinicalTrials.gov Identifier: NCT02763709|
Recruitment Status : Recruiting
First Posted : May 5, 2016
Last Update Posted : May 5, 2016
|Condition or disease|
|Critical Illness Polyneuropathy|
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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
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.
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.
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.
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 :||Observational|
|Estimated Enrollment :||97 participants|
|Official Title:||Evaluation of Pediatric Critical Illness Neuropathy/Myopathy in Pediatric Intensive Care Unit|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||December 2016|
Children admitted in Pediatric ICU for more than 24 hours with Pediatric Risk of Mortality (PRISM) score III > 20
- Incidence of Pediatric critical illness polyneuropathy/myopathy [ Time Frame: 1 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02763709
|Contact: Ananthanarayanan K, MDemail@example.com|
|Chandigarh, India, 160012|
|Contact: Naveen Sankhyan, MD DM firstname.lastname@example.org|
|Contact: Pratibha Singhi, MD email@example.com|
|Principal Investigator:||Naveen Sankhyan, DM||Postgraduate Institute of Medical Education and Research|
|Principal Investigator:||Pratibha Singhi, MD||Postgraduate Institute of Medical Education and Research|