Impact of Early Mobilization on Diaphragm Thickness in Critically Ill Children

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

This study is testing if getting critically ill children moving early while they are on a ventilator can help keep their diaphragm stronger compared to just regular care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 6 Months to 12 Years
• Sex: All
• Sponsor: Children's Hospital of Fudan University (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT04534296 on ClinicalTrials.gov

What this trial studies

This study aims to compare the effects of early mobilization versus routine care on diaphragm thickness in critically ill children who are mechanically ventilated. Mechanical ventilation can lead to diaphragm weakness, known as ventilator-induced diaphragm dysfunction (VIDD), which can be assessed using bedside ultrasonography. The researchers hypothesize that early mobilization will reduce the incidence of diaphragm atrophy compared to standard care. By conducting a randomized trial, they will evaluate changes in diaphragm thickness over time in the participating children.

Who should consider this trial

Good fit: Ideal candidates are children aged 6 months to 12 years who have been intubated and mechanically ventilated for less than 24 hours.

Not a fit: Patients with a history of diaphragmatic paralysis, neuromuscular disease, or those expected to be liberated from the ventilator in less than 24 hours may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve diaphragm function and recovery in critically ill children on mechanical ventilation.

How similar studies have performed: While the approach of early mobilization is gaining attention, the specific impact on diaphragm thickness in this population is still being explored and may be novel.

Eligibility criteria

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

Where this trial is running

Shanghai

• Children's Hospital, Fudan University — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Sujuan Wang

Conditions Mechanical Ventilation Complication; Ventilator-induced Diaphragm Dysfunction