How Early Mobilization Impacts on Diaphragm Thickness in Critically Ill Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorChildren's Hospital of Fudan University
About this trial
The objective is to compare the impact of early mobilization and routine care on diaphragm thickness in critically ill children
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
cardiopulmonary arrest;
history of diaphragmatic paralysis or neuromuscular disease;
neuromuscular blockade;
expectation to be liberated from ventilator in < 24 hours
Trial design
Design model
Parallel
Treatments tested in this trial
early mobilization
Other interventionEarly 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.
routine care
Other interventionIn 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.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Early Mobilization Group (EM group)Experimental treatment 1 intervention
Group B: Routine Care Group (RC group)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
from intubation up to 7 daysSecondary outcomes
1
the diaphragm thickness
the diaphragm thickness measured by ultrasonography
Time frame
from intubation up to 7 days2
diaphragmatic thickening fraction (DTF)
the calculation formula of DTF is defined as (Tdi-insp - Tdi-exp)/Tdi-exp x 100
Time frame
from intubation up to 7 days3
mechanical ventilation time
We define the successful weaning as no requirement for reintubation within 48 hours following extubation
Time frame
from intubation to the day when children are successfully weaned (about 10 days )4
PICU length of stay
the days when children stayed in PICU
Time frame
days from admission to discharge from PICU (about 20 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov