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"PICU Up!" Early Mobility Intervention for Critically Ill Children (PICU Up! Trial)

N/A

Recruiting

Led By Sapna Kudchadkar, MD, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be younger than 65 years old

Must not have

Open chest or open abdomen

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through day 21

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new interprofessional intervention (PICU Up!) to help decrease the duration of mechanical ventilation for critically ill children, with the goal of improving physical and psychological outcomes.

Who is the study for?

This trial is for children in the PICU who have been on a breathing machine through their mouth or nose for at least 48 hours by the morning of their third day in care. It's not for kids if life support might be stopped soon, they have an open chest or abdomen, or are using ECMO (a heart-lung bypass machine).

What is being tested?

The 'PICU Up!' intervention is being tested to see if it can reduce how long critically ill children need mechanical ventilation. It combines managing sedation, preventing delirium, promoting sleep, and involving families to help these kids start moving sooner and more safely.

What are the potential side effects?

Since 'PICU Up!' focuses on early mobility and involves non-drug interventions like physical activity and family involvement, there aren't typical medication side effects. However, there may be risks associated with moving critically ill patients too early or quickly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on a breathing machine for more than 48 hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had an open chest or abdomen surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through day 21

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through day 21

This trial's timeline: 3 weeks for screening, Varies for treatment, and through day 21 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Duration of Mechanical Ventilation

Secondary study objectives

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

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

Proportion of Days with Delirium

Other study objectives

Mean daily Benzodiazepine exposure

Mean daily Opioid exposure

Number of patients discharged to home

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Baseline/Pre-implementationActive Control1 Intervention

Usual PICU care

Group II: Intervention/Post-implementationActive Control1 Intervention

PICU Up! is a multifaceted, inter-professional pathway that is integrated into routine PICU practice to safely optimize early and progressive patient mobility.

0 / 2Eligibility criteria met