Paediatric Early Rehabilitation/Mobilisation During InTensive Care

NCT04110938 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2019-10-01

No results posted yet for this study

Summary

In the UK, critical illness or injury affects about 19,000 Children and Young Persons (CYP) every year who are admitted to the paediatric intensive care unit (PICU) to receive life-sustaining treatments. Although survival rates from PICU are at an all-time high (\>96%), low levels of mortality have been offset by an increase in morbidity. The impact of being critically ill and exposed to the PICU is multiple. Weakness, cognitive impairment, organ dysfunction, and psychological problems have been reported to emanate from deconditioning. Subsequently, post-PICU many CYP experience significant and residual physical, cognitive, and psychosocial morbidities that impact on their quality of life. The contemporary focus has turned to the development, testing, and implementation of interventions to minimize the harmful effects of critical care and maximize patient outcomes.

Early rehabilitation and/or mobilisation (ERM) encompasses patient-tailored interventions, delivered individually or in a bundled package, provided by health professionals from multiple disciplines and care-givers within intensive care settings to promote recovery, both physical (e.g. movement, functional activities, ambulation) and non-physical (e.g. speech, play, psychological, cognitive).

Rehabilitation has been shown to improve quality of life and patient outcomes; reduce health inequalities, and make significant savings to the health care system. Benefits have been demonstrated in the use of ERM in adult ICU populations in relation to patient outcomes as well as healthcare utilization. Studies also indicate that the intervention is safe and feasible, reduces delirium and increases ventilator-free days, improves day-to-day functioning and reduces hospital readmissions. However, in the United Kingdom (UK), the understanding of current ERM practices (including content, barriers, facilitators, feasibility, and safety) and their impact on the outcomes of pediatric ICU patients is limited. This has stifled an evidence-based approach to ERM which has resulted in disparity in the adoption and utilization of ERM interventions in PICUs across the UK.

To address this critical gap, the first phase of a four-phase program of the PERMIT study will generate evidence of current PICU ERM practices by conducting a survey and an observational study.

The second phase of the study will involve conducting qualitative workshops to develop a prototype ERM program. Qualitative workshops will also be conducted among key stakeholders (clinicians, parents, CYP) to inform the design of an ERM intervention.

The third phase will investigate this ERM program in a pilot study in UK PICUs and finally, the efficacy of the intervention will be tested using a large scale, definitive randomized controlled trial (RCT).

Conditions

  • ICU
  • Critical Illness

Sponsors & Collaborators

  • University of Nottingham

    collaborator OTHER
  • Newcastle University

    collaborator OTHER
  • Northumbria University

    collaborator OTHER
  • University of Cambridge

    collaborator OTHER
  • University of Leeds

    collaborator OTHER
  • Imperial College London

    collaborator OTHER
  • University of Birmingham

    lead OTHER

Principal Investigators

  • Barnaby Scholefield, Dr · Birmingham Women's and Children's Hospital

Eligibility

Min Age
38 Weeks
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-28
Primary Completion
2019-11-30
Completion
2020-10-31

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04110938 on ClinicalTrials.gov