How Early Mobilization Impacts on Diaphragm Thickness in Critically Ill Children

Study Overview
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Brief Summary
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The objective is to compare the impact of early mobilization and routine care on diaphragm thickness in critically ill children

Detailed Description
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Mechanical ventilation is a life-supporting therapy that intrinsically induces diaphragm rest. Consequently, mechanical ventilation induces time-dependent diaphragm weakness in animals and in critically ill patients, and is referred to as ventilator-induced diaphragm dysfunction (VIDD). In most cases with VIDD, the decrease in diaphragm thickness can be detected by bedside Ultrasonography. The onset of diaphragm atrophy in the intensive care unit could be very rapid (fewer than 5 days). Vivier E. defined muscle atrophy as greater than or equal to a 10% decrease in muscle thickness on day 5 compared to day 1. It's found that diaphragm atrophy occured in 17/35 (48%). However, There is always some cases presented an increase in diaphragm thickness. Goligher EC. reported that approximately 20% of mechanically ventilated patients exhibit an increase in diaphragm thickness. In our previous study, there were about 46.7%(14/30) of ventilated children had increased diaphragmatic thickness. It's supposed that the thickening might associated with the diaphragm injury during mechanical ventilation. Early mobilization may enhance the weaning of ventilated children, so the investigators hypothesize that the percentile of cases with increase diaphragmatic thickness will decline by early mobilization. To investigate this hypothesis, investigators are conducting a randomized trial examining the effects of early mobilization versus routine care on changing tendency of diaphragm thickness. Enrolled children requiring mechanical ventilation will be randomized to either early mobilization group or routine care group. Diaphragm thickness will be measured by ultrasound on day1, day3, day5 and day7 after intubation and subsequently diaphragm thickness changing tendency will be calculated in each arm. The operator acquiring ultrasound images will be blinded to the care mode that the subject was randomized to. Subjects in the study will follow standard ICU sedation awakening trials and spontaneous breathing trials. The medical team in charge of the subject will determine when the subject is safe to receive early mobilization according to the standard established along with the rehabilitation team.

Official Title
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A Randomized Control Trial Comparing the Effects of Early Mobilization and Routine Care on Diaphragmatic Thickness

Conditions
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Mechanical Ventilation Complication, Ventilator-induced Diaphragm Dysfunction

Intervention / Treatment
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* Other: early mobilization
* Other: routine care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subjects > 6 months and < 12 years of age； subjects been intubated and mechanically ventilated for < 24 hours at the time of screening; the Glasgow Coma Scale (GCS) on admission of Pediatric Intensive Care Unit (PICU) is greater than 3 Exclusion Criteria: cardiopulmonary arrest; history of diaphragmatic paralysis or neuromuscular disease; neuromuscular blockade; expectation to be liberated from ventilator in < 24 hours history of mechanical ventilation in the last 6 months presence of tracheostomy high cervical spine injury status convulsion thoracic trauma when ultrasonic examination cannot be performed

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Mobilization Group (EM group)<br>Early mobilization will be performed in this arm. Critically ill children will be assessed for appropriate activity within 24 hours of intubation. When the safe criteria is met, early mobilization goals will be set according to the children's clinical conditions, developmental maturity, strength and endurance. The detailed mobilization activities include bed repositioning，passive or active range of motion and stretching exercises, passive or active respiratory muscle strengthening, sitting in bed, transfer from lying to sitting at edge of bed. Progressive mobilization goals will be individualized for each subject daily. | Other: early mobilization<br>* Early mobilization is a kind of rehabilitation strategy. When the safe standards are met, early mobilization will be performed on subjects randomized in EM group for 30 minutes each time, twice a day, from Monday to Friday. The detailed mobilization activities include bed repositioning，passive or active range of motion and stretching exercises, passive or active respiratory muscle strengthening, sitting in bed, transfer from lying to sitting at edge of bed. Progressive mobilization goals will be individualized for each subject daily, corresponding to their clinical conditions, developmental maturity, strength and endurance.<br>|
| Active Comparator: Routine Care Group (RC group)<br>Routine care strategy without early mobilization will be performed in this arm. It includes the clinical status management, spontaneous breathing trials, choice of sedation and analgesia and routine nursing care including repositioning every 2 hours and bed head elevation. | Other: routine care<br>* In this arm, no additional early rehabilitation interventions will be performed except for the routine clinical care, including the ventilation management, spontaneous breathing trials, choice of sedation and analgesia and routine nursing care including repositioning every 2 hours and bed head elevation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percentile of cases with increased diaphragm thickness | we define the increase of diaphragm thickness as greater than 0 increase in diaphragm thickness on day5 compared to day1 | from intubation up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the diaphragm thickness | the diaphragm thickness measured by ultrasonography | from intubation up to 7 days | 
| diaphragmatic thickening fraction (DTF) | the calculation formula of DTF is defined as (Tdi-insp - Tdi-exp)/Tdi-exp x 100 | from intubation up to 7 days | 
| mechanical ventilation time | We define the successful weaning as no requirement for reintubation within 48 hours following extubation | from intubation to the day when children are successfully weaned (about 10 days ) | 
| PICU length of stay | the days when children stayed in PICU | days from admission to discharge from PICU (about 20 days) |