Ireland
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Enrolling by invitation Observational

Development of an Early Warning Model for Intensive Care Unit-Acquired Weakness in Mechanically Ventilated Children

NCT07150637 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2026-03-01
Last updated
2026-03-19

Condition(s) studied

ICU Acquired Weakness

Investigational drug(s) / intervention(s)

ICU-AW

ICU-AW: The enrolled children receiving mechanical ventilation were grouped based on the occurrence of ICU-acquired weakness (ICU-AW) at the study endpoint.

Study summary

Acquired weakness (AW) is a common complication among patients in the Intensive Care Unit (ICU). It is a systemic muscle weakness and dysfunction associated with critical illness, often related to prolonged bed rest, mechanical ventilation, systemic inflammatory response syndrome (SIRS), and multiple organ dysfunction syndrome (MODS). The primary clinical manifestations include weakness in limb and respiratory muscles, particularly diminished strength in distal muscle groups. As a result, the weaning process from mechanical ventilation becomes more challenging, leading to prolonged ICU stays, increased mortality, and a higher risk of long-term functional disability. The significance of AW lies not only in its substantial impediment to short-term recovery but also in its role as a core component of Post-Intensive Care Syndrome (PICS), profoundly affecting patients' long-term outcomes.

Mechanical ventilation is a vital life-support technology for critically ill children in the Pediatric Intensive Care Unit (PICU). However, complications associated with mechanical ventilation have garnered increasing attention, particularly Acquired Weakness in mechanically ventilated children. With improving survival rates in the PICU, a growing number of pediatric critical illness survivors are at risk of developing AW. Despite rapid advancements in pediatric critical care medicine in China, there is currently a lack of an early warning system for AW in children receiving mechanical ventilation, resulting in significantly delayed clinical interventions. This project aims to identify novel biomarkers for pediatric ICU-AW and develop an early warning model. It holds promise for transitioning from the traditional post-symptomatic diagnostic approach to subclinical prediction of AW in children, which is of great clinical value for reducing disability rates and optimizing critical care rehabilitation strategies.

Eligibility

Sex
ALL
Min age
1 Month
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age between 28 days and 18 years; 2. Patients continuously admitted to the PICU during the study period and subjected to invasive mechanical ventilation. Exclusion Criteria: 1. Mechanical ventilation duration \< 72 hours; 2. Presence of primary central or neuromuscular diseases that significantly affect central or peripheral respiratory failure, including: traumatic brain injury, cerebrovascular disease history (e.g., cerebral hemorrhage, cerebral infarction), intracranial tumors, central nervous system infections, spinal cord injury, Guillain-Barré syndrome, porphyria, paraneoplastic neuropathy, etc.; 3. Conditions requiring immobilization such as limb joint surgery or fractures.

Primary outcome measure(s)

  • The occurrence rate of ICU-AW — Diagnosis of ICU-AW in mechanically ventilated children was determined based on assessments at day 10.
    The occurrence rate of ICU-AW in mechanically ventilated children on day 10. ICU-AW was defined as: MRC score \< 48, or slowed nerve conduction velocity on electromyography; CIP: normal or mildly reduced nerve conduction velocity, reduced CMAP amplitude, reduced mixed SNAP amplitude; CIM: normal or mildly reduced nerve conduction velocity, reduced CMAP amplitude, decreased muscle excitability to direct stimulation, increased CMAP duration, normal SNAP; or confirmed by muscle biopsy.

Trial sites (1)

FacilityCityRegionStatus
Children' hospital of Fudan university Shanghai Shanghai Municipality
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 NCT07150637 on ClinicalTrials.gov ↗ ← All trials in China