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

NCT07150637 | Enrolling By Invitation

• 1 other identifier: ICU-AW 20250824
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ICU Acquired Weakness

Keywords

ICU acquired weakness

Outcome Measures

Primary Outcomes (1)

• The occurrence rate of ICU-AW

  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.

  Diagnosis of ICU-AW in mechanically ventilated children was determined based on assessments at day 10.

Secondary Outcomes (5)

• Diaphragm Thickness:

  mechanically ventilated children on day 0，day 3, day 7，day 10

• Rectus Femoris Muscle Thickness and Cross-Sectional Area

  mechanically ventilated children on day 0，day 3, day 7，day 10

• duration of MV in days

  when patient weaning from mechanical ventilation

• length of stay in the ICU and in hospital

  when patients leave from ICU and discharge hospital

• hand-grip strength scoring at ICU

  mechanically ventilated children on day 0，day 3, day 7，day 10, leave ICU

Study Arms (2)

ICU-AW

Children receiving mechanical ventilation who developed ICU-AW at the study endpoint.

Diagnostic Test: ICU-AW

without ICU-AW

Children receiving mechanical ventilation who did not developed ICU-AW at the study endpoint.

Interventions

ICU-AW DIAGNOSTIC_TEST

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

ICU-AW

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Age between 28 days and 18 years;
• Patients continuously admitted to the PICU during the study period and subjected to invasive mechanical ventilation.

You may not qualify if:

• Mechanical ventilation duration \< 72 hours;
• 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.;
• Conditions requiring immobilization such as limb joint surgery or fractures.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children' hospital of Fudan university

Shanghai, Shanghai Municipality, 201102, China

Location

Related Publications (5)

• Kalb R. ICU-acquired weakness and recovery from critical illness. N Engl J Med. 2014 Jul 17;371(3):287. doi: 10.1056/NEJMc1406274. No abstract available.

  PMID: 25014704 BACKGROUND

• Johnson RW, Ng KWP, Dietz AR, Hartman ME, Baty JD, Hasan N, Zaidman CM, Shoykhet M. Muscle atrophy in mechanically-ventilated critically ill children. PLoS One. 2018 Dec 19;13(12):e0207720. doi: 10.1371/journal.pone.0207720. eCollection 2018.

  PMID: 30566470 BACKGROUND

• Zhang Z, Cai X, Ming M, Huang L, Liu C, Ren H, Qu D, Gao H, Cheng Y, Zhang F, Yang Z, Xu W, Miao H, Liu P, Liu Y, Lu G, Chen W. Incidence, outcome, and prognostic factors of prolonged mechanical ventilation among children in Chinese mainland: a multi-center survey. Front Pediatr. 2024 May 30;12:1413094. doi: 10.3389/fped.2024.1413094. eCollection 2024.

  PMID: 38873585 BACKGROUND

• Zhang Z, Tao J, Cai X, Huang L, Liu C, Ren H, Qu D, Gao H, Cheng Y, Zhang F, Yang Z, Xu W, Miao H, Liu P, Liu Y, Lu G, Chen W. Clinical characteristics and outcomes of children with prolonged mechanical ventilation in PICUs in mainland China: A national survey. Pediatr Pulmonol. 2023 May;58(5):1401-1410. doi: 10.1002/ppul.26332. Epub 2023 Feb 8.

  PMID: 36705329 BACKGROUND

• Banwell BL, Mildner RJ, Hassall AC, Becker LE, Vajsar J, Shemie SD. Muscle weakness in critically ill children. Neurology. 2003 Dec 23;61(12):1779-82. doi: 10.1212/01.wnl.0000098886.90030.67.

  PMID: 14694046 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 2, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

CN (1)