How Early Mobilization Impacts on Diaphragm Thickness in Critically Ill Children

NCT04534296 · tracked via the Priya Life Science China tracker

Sponsor

Children's Hospital of Fudan University

Phase

Not applicable

Started

2021-04-26

Last updated

2025-02-12

Condition(s) studied

Mechanical Ventilation ComplicationVentilator-induced Diaphragm Dysfunction

Investigational drug(s) / intervention(s)

early mobilizationroutine care

early 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.

routine 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.

Study summary

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

Eligibility

Sex

ALL

Min age

6 Months

Max age

12 Years

Healthy volunteers

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

Primary outcome measure(s)

the percentile of cases with increased diaphragm thickness — from intubation up to 7 days
we define the increase of diaphragm thickness as greater than 0 increase in diaphragm thickness on day5 compared to day1

Trial sites (1)

Facility	City	Region	Status
Children's Hospital, Fudan University	Shanghai	China	Recruiting

More Children's Hospital of Fudan University trials in China

PK/PD of Caspofungin in Children Severe Infection Recruiting

Research on Circulation Management Strategy Based on Oxygen Metabolism Balance After CHD Surgery Enrolling by invitation

Dupilumab Therapy for EGIDs Recruiting

Child-Parent Familial Hypercholesterolemia Screening Recruiting

Blood Purification in Septic Children Starting soon

Other trials for the same condition

Efficacy and Safety of Remimazolam Besylate for Sedation in Post-Non-Cardiac Surgery Patients Requiring Mechanical Ventilation Recruiting

EIT-guided PEEP Titration Versus Standard Ventilation in Bariatric Surgery Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04534296 on ClinicalTrials.gov ↗ ← All trials in China