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NCT Number: NCT04989790

Clinical Effectiveness of the "PICU Up!" Multifaceted Early Mobility Intervention for Critically Ill Children

While mortality in U.S. pediatric intensive care units (PICUs) is improving, surviving children frequently develop persistent physical, cognitive, and psychological impairments. Over half of critically ill children experience potentially preventable PICU-acquired morbidities, with mechanically ventilated children being at greatest risk. In critically ill adults, randomized trials have shown that progressive mobility, started early (within 3 days of initiating mechanical ventilation), decreases muscle weakness and the duration of mechanical ventilation. However, similar randomized studies have not been conducted in the PICU. The investigator's prior studies revealed that less than 10 percent of critically ill children at the highest risk of functional decline are evaluated by a physical or occupational therapist within 3 days of PICU admission. Given the interplay of sedation, delirium, sleep, and immobility in the PICU, single-component interventions, such as sedation protocolization, have not consistently shown benefit for decreasing mechanical ventilation duration. Thus, the investigators developed the first pediatric-specific, interprofessional intervention (PICU Up!) to integrate goal-directed sedation, delirium prevention, sleep promotion, and family engagement into daily PICU care in order to facilitate early and progressive mobility. The investigators have demonstrated the safety and feasibility of this pragmatic, multifaceted strategy in both single-site and multicenter pilot studies. Hence, the next phase of the investigators research is to evaluate the clinical effectiveness and delivery of the PICU Up! intervention across a range of PICU patients and health systems. The investigators propose a pragmatic, stepped-wedge, cluster randomized controlled trial that will include 10 academic and community hospitals in the United States, with the following Aims: 1) Evaluate if the PICU Up! intervention, delivered under real-world conditions, decreases mechanical ventilation duration (primary outcome) and improves delirium and functional status compared to usual care in critically ill children; and 2) Conduct a multi-stakeholder, mixed-methods process evaluation to identify key contextual factors associated with delivery of PICU Up!. If proven effective, the PICU Up! intervention has potential to profoundly change medical care in the PICU and substantially impact public health by improving outcomes for the growing number of pediatric survivors of critical illness.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Valley Children's Hospital, Madera, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Invasive mechanical ventilation via oral or nasal endotracheal tube ≥ 48 hours at 7 a.m. on PICU Day 3

Exclusion criteria

  • Active or anticipated withdrawal of life support within 48 hours
  • Open chest or open abdomen
  • Current use of Extracorporeal Membrane Oxygenation (ECMO)

Treatment and study plan

PICU Up!

Other

PICU Up! incorporates the screening process for determining a patient's appropriate activity level into the daily rounding workflow for all PICU patients, with a tiered activity plan based on clinical parameters to individualize goals based on each child's unique needs. While the patient's PICU Up! level is based on objective criteria, the interprofessional team collectively determines the daily activity goal(s) through shared decision-making which is documented in the medical record on morning rounds. The intervention facilitates daily discussion of 1) analgesia; 2) extubation readiness testing; 3) sedation level and goal; 4) delirium screening and management; 5) mobility goal including physical and occupational therapy consultation by PICU Day 3; 6) sleep promotion; and 7) family engagement in mobility.

Primary outcomes

  1. Duration of Mechanical Ventilation

    Time frame: Through Day 21

    In computing duration of mechanical ventilation, the investigators will consider Time 0 as the time of endotracheal intubation or PICU admission for patients intubated at an outside hospital, and continuing until the first time the endotracheal tube was continuously absent for at least 24 hours. Patients will be assigned 21 days for ventilation duration if they remain intubated and mechanically ventilated, are transferred to another facility while ventilated or die prior to day 21 without ever remaining off mechanical ventilation ventilation (via endotracheal tube) for more than 24 continuous hours. If a patient is transitioned to mechanical ventilation via a new tracheostomy those days will be counted as mechanical ventilation days.

Secondary outcomes

  1. Proportion of Days with Delirium

    Time frame: Through Day 21

    Defined as the number of days with delirium divided by the total number of days that the child is at risk for delirium (i.e. the number of days that the patient is in the PICU and free of coma and therefore assessable for delirium).

  2. Change in Functional Status as assessed by the Pediatric Cerebral Performance Category (PCPC) scale

    Time frame: Through Day 21

    The Pediatric Cerebral Performance Category is a global scale based on observer impressions. It's is a six point graded scale of increasing disability from 1 normal function, to 6 death. Scores include 1 for good, 2 for mild disability, 3 for moderate disability, 4 for severe disability, and 5 for vegetative state or coma. Higher scores indicating worse performance or functional morbidity.

  3. Change in Functional Status as assessed by the Pediatric Overall Performance Category (POPC) scale

    Time frame: Through Day 21

    The Pediatric Overall Performance Category (POPC) is a global scale based on observer impressions. It's is a six point graded scale of increasing disability from 1 normal function, to 6 death. Scores include 1 for good, 2 for mild disability, 3 for moderate disability, 4 for severe disability, and 5 for vegetative state or coma. Higher scores indicating worse performance or functional morbidity.

Other outcomes

  1. PICU length of stay

    Time frame: Through Day 21

    PICU length of stay days

  2. Percentage of patients PICU mortality

    Time frame: Through Day 21

    PICU mortality

  3. Number of patients discharged to home

    Time frame: Through Day 21

    Number of patients discharged to home

  4. Number of patients discharged to inpatient floor

    Time frame: Through Day 21

    Number of patients discharged to inpatient floor

  5. Number of patients discharged to inpatient rehabilitation

    Time frame: Through Day 21

    Number of patients discharged to inpatient rehabilitation

  6. Number of patients discharged to other hospital

    Time frame: Through Day 21

    Number of patients discharged to other hospital

  7. Percentage of patients with new pressure injuries

    Time frame: Through Day 21

    Percentage of patients with new pressure injuries

  8. Percentage of patients with physical therapy consultation

    Time frame: Day 3

    Physical therapy consultation by PICU

  9. Percentage of patients with occupational therapy consultation

    Time frame: Day 3

    Occupational therapy consultation by PICU

  10. Mean daily Opioid exposure

    Time frame: Through Day 21

    Opioid exposure: mean daily morphine and equivalents (mg/kg/day) via chart review

  11. Mean daily Benzodiazepine exposure

    Time frame: Through Day 21

    Benzodiazepine exposure: mean daily benzodiazepine equivalents (mg/kg/day) via chart review

Study contacts

Contact information is provided by the study sponsor or research team.

Colleen Mennie, RN

CONTACT

[email protected]

410-955-6412

Sapna R Kudchadkar, MD, PhD

CONTACT

[email protected]

410-955-6412

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Clinical Effectiveness of the "PICU Up!" Multifaceted Early Mobility Intervention for Critically Ill Children: A Pragmatic, Stepped-wedge Trial

Acronym: PICU Up!

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Aug 4, 2021
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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