RecruitingNot ApplicableNCT04534296

How Early Mobilization Impacts on Diaphragm Thickness in Critically Ill Children

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


Sponsor

Children's Hospital of Fudan University

Enrollment

160 participants

Start Date

Apr 26, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 6 MonthsMax Age: 12 Years

Inclusion Criteria3

  • 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 Criteria9

  • 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

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Interventions

OTHERearly mobilization

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.

OTHERroutine care

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.


Locations(1)

Children's Hospital, Fudan University

Shanghai, China

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NCT04534296


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