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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through day 21

Awards & highlights

PICU Up! Trial 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).Check my eligibility

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.See study design

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.

PICU Up! Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

PICU Up! Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Duration of Mechanical Ventilation

Secondary outcome measures

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 outcome measures

Mean daily Benzodiazepine exposure

Mean daily Opioid exposure

Number of patients discharged to home

+8 more

PICU Up! 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,266 Previous Clinical Trials

14,836,057 Total Patients Enrolled

13 Trials studying Critical Illness

205,151 Patients Enrolled for Critical Illness

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

1,965 Previous Clinical Trials

2,671,357 Total Patients Enrolled

6 Trials studying Critical Illness

1,084 Patients Enrolled for Critical Illness

Sapna Kudchadkar, MD, PhDPrincipal InvestigatorJohns Hopkins University

Media Library

PICU Up! Clinical Trial Eligibility Overview. Trial Name: NCT04989790 — N/A

Critical Illness Research Study Groups: Baseline/Pre-implementation, Intervention/Post-implementation

Critical Illness Clinical Trial 2023: PICU Up! Highlights & Side Effects. Trial Name: NCT04989790 — N/A

PICU Up! 2023 Treatment Timeline for Medical Study. Trial Name: NCT04989790 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum number of individuals that can participate in this clinical experiment?

"Affirmative. The information on clinicaltrials.gov states that this trial has initiated recruitment and is scouting for 1440 participants from 10 sites since August 8th 2022, with the latest update being posted September 9th 2022."

Answered by AI

How many locations are participating in this experiment?

"10 medical sites are currently involved in this research project, such as Texas Children's Hospital: Baylor College of Medicine in Houston, Valley Children's Hospital in Madera, and Norton Children’s Hospital: University of Louisville. Additionally there are 7 other clinical locations participating."

Answered by AI

Is the trial currently recruiting new participants?

"Confirmed. Clinicaltrials.gov indicates that from the time it was first published on August 8th 2022, this medical trial is still actively recruiting volunteers. About 1440 participants are needed for 10 different centres."

Answered by AI