Critical Illness Clinical Trial
Official title:
Paediatric Early Rehabilitation/Mobilisation During InTensive Care: An Observational Study
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).
The PERMIT study aims to ascertain current ERM practices within PICU settings and
barriers/facilitators to ERM delivery.
The investigators plan to directly observe current ERM practices within UK PICUs, identify
patients who do and do not receive ERM, describe the variation between PICUs and factors
associated with ERM practices.
Inclusion Criteria:
1. All Children and Young Persons (CYP) (0-<16 years)
2. Admitted to PICU
3. Remain within PICU on day 3 post-admission
The broad inclusion criteria will allow for the observation of all types of patients admitted
for PICU care (acute and elective e.g. post-surgical recovery) and all age ranges.
Exclusion criteria:
1. A local decision by a Principal investigator (PI) or treating clinical team not to
include patient
2. Parent or guardian chooses to opt-out
Prospective data about all children admitted to PICU for 3 days or more will be collected.
Eligible patients will be identified, screened and enrolled in the study. Posters and patient
information leaflets will be provided to parents/legal guardians within participating PICU
explaining their rights to withdraw from the study without affecting the future care of their
child. Data collected as part of the study will be stored for ten years, in line with Good
Clinical Practice (GCP) guidelines. No identifiable data will be collected or shared with the
PERMIT study team at any time.
Following the observation of current ERM delivery and identification of patients who may
benefit from ERM in selected PICUs, the study investigators will use this information to
model how many patients may be available in the UK for a potential future RCT. This will be
achieved by modeling patient demographic information with the Paediatric Intensive Care Audit
Network (PICANet) dataset.
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