Clinical trial NCT04524065: Effectiveness and Safety of an Early Mobilization Protocol in a Pediatric Intensive Care Unit
Official title: Effectiveness and Safety of an Early Mobilization Protocol in a Pediatric Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Illness
Keywords: PICU
acute rehabilitation
early mobilization
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2020-08-24
Enrollment: 142
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study evaluates the safety and effectiveness of an early rehabilitation program in a pediatric intensive care unit (PICU). Half of the participants will receive intensive and frequent an early mobilization program and others will receive conservative mobilization program.

Detailed description: The 14 early rehabilitation sessions(10=physical therapy, 4=occupational therapy) occurred per week over a 2-week period (excluding weekends) in the early rehabilitation group for 15 minutes each. The control group received 2 sessions(physical therapy) per week over a 2-week period for 10 minutes each.

Eligibility criteria: Inclusion Criteria:

* Children admitted to the PICU due to critical illness
* Children aged 1-18 years

Exclusion Criteria:

* Increased intracranial pressure(ICP)
* History of brain surgery
* Children with fracture
* Admitted to the participating PICU ≤ 3 days
* Children with suspected brain death

Primary outcomes:
measure: Change From Baseline Functional Status Score (FSS) at Post Test(PICU discharge)
timeFrame: Evaluation is conducted at two time points. At baseline (T0), assessment is carried out for within 7 days after admission to the PICU. For T1, assessment occurs within 7 days after PICU discharge or, for patients unable to be discharged, at the 30-da
Secondary outcomes:
measure: The Pediatric Evaluation of Disability Inventory-Computer Adaptive Test(PEDI-CAT)
timeFrame: Evaluation is conducted at two time points. At baseline (T0), assessment is carried out for within 7 days after admission to the PICU. For T1, assessment occurs within 7 days after PICU discharge or, for patients unable to be discharged, at the 30-da
measure: Duration of mechanical ventilation (days)
timeFrame: Perioid between intubation and extubation of mechanical ventilation
measure: PICU length of stay (days)
timeFrame: From PICU admission to discharge
measure: Hospital length of stay (days)
timeFrame: From Baseline to hospital discharge
measure: Number of patients discharged from the hospital to a place other than home
timeFrame: At hospital discharge
measure: Safety index
timeFrame: Evaluation is conducted at two time points. At baseline (T0), assessment is carried out for within 7 days after admission to the PICU. For T1, assessment occurs within 7 days after PICU discharge or, for patients unable to be discharged, at the 30-da
measure: The Pediatric Risk of Mortality III (PRISM III)
timeFrame: At PICU admission
measure: Change From post-test(PICU discharge) Pediatric Quality of Life Inventory version 4.0 (PedsQL 4.0) at follow-up test(2 months)
timeFrame: Evaluation is conducted at two time points. At baseline (T0), assessment is carried out for within 7 days after admission to the PICU. For T1, assessment occurs within 7 days after PICU discharge or, for patients unable to be discharged, at the 30-da
measure: Change From baseline The State-Trait Anxiety Inventory (STAI) at follow-up test(2 months)
timeFrame: Evaluation is conducted at two time points. At baseline (T0), assessment is carried out for within 7 days after admission to the PICU. For T1, assessment occurs within 7 days after PICU discharge or, for patients unable to be discharged, at the 30-da
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Evaluation is conducted at two time points. At baseline (T0), assessment is carried out for within 7 days after admission to the PICU. For T1, assessment occurs within 7 days after PICU discharge or, for patients unable to be discharged, at the 30-da
measure: Muscle strength measures of elbow flexor and knee extensor obtained with a hand-held dynamometer(MicroFET2).
timeFrame: Evaluation is conducted at two time points. At baseline (T0), assessment is carried out for within 7 days after admission to the PICU. For T1, assessment occurs within 7 days after PICU discharge or, for patients unable to be discharged, at the 30-da
measure: Pediatric Sequential Organ Failure Assessment(pSOFA)
timeFrame: Evaluation is conducted at two time points. At baseline (T0), assessment is carried out for within 7 days after admission to the PICU. For T1, assessment occurs within 7 days after PICU discharge or, for patients unable to be discharged, at the 30-da
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jeong-Yi Kwon, PhD
role: PRINCIPAL_INVESTIGATOR
References: