|- candidate number||28338|
|- NTR Number||NTR6898|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-dec-2017|
|- Secondary IDs||MEC-2017-1095 Erasmus MC|
|- Public Title||Early mobilization in critically ill children|
|- Scientific Title||Effectiveness of early mobilization in critically ill children|
|- ACRONYM||Early mob|
|- hypothesis||An early mobilization program in critically ill children reduce the consumption of sedatives and opioids and the prevalence of delirium.|
|- Healt Condition(s) or Problem(s) studied||Pediatric delirium, Critically ill children|
|- Inclusion criteria||Children with an expected length of stay in PICU of at least 3 days.
|- Exclusion criteria||patients with: |
- open chest, preexisting chronic neuromuscular disorder, acute spinal cord injuries, anticipated death or withholding life-sustaining therapy.
- no parental consent.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-dec-2017|
|- planned closingdate||1-dec-2018|
|- Target number of participants||60|
|- Interventions||This quality improvement project involved a usual- care baseline phase, followed by a quality improvement phase that implemented an interdisciplinary, and tiered activity plan to promote early mobilization of critically ill children.|
|- Primary outcome||Prevalence of delirium |
|- Secondary outcome||- Difference in consumption of sedatives/opiods before and after the intervention. |
- Prevalence distress, and withdrawal syndrome in intervention group compared with the control group. - The number and type of mobilization activities before and after the intervention.
- Mobilization related adverse events (safety) intervention group and control group.
- The health status, e.g. Activities of Daily Living (ADL) and sleep after PICU discharge.
|- Timepoints||- 4 months pre-test period|
- 8 months post-test
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. E. Ista|
|- CONTACT for SCIENTIFIC QUERIES||Dr. E. Ista|
|- Sponsor/Initiator ||Erasmus Medical Center, Sophia Children's Hospital|
(Source(s) of Monetary or Material Support)
|Evidence Based Care for Nursing Grant, Erasmus MC|
|- Brief summary||Rationale: Providing early mobilization during the Intensive Care Unit (ICU) stay has shown effective in adults. Evidence in critically ill children is lacking.|
Objective: To determine the effect of an early mobilization program in a PICU on the consumption of sedatives and opioids (mg/kg) compared to usual care during the first 28 days. The secondary objective is the determine the prevalence of distress, delirium and withdrawal syndrome after implementation of an early mobilization program.
Study design: An observation before-after implementation study
Study population: Children from 0 to 17 years with the expectation of at least three days admitted to the PICU.
Intervention (if applicable): This quality improvement project involved a usual- care baseline phase, followed by a quality improvement phase that implemented an interdisciplinary, and tiered activity plan to promote early mobilization of critically ill children. Main study parameters/endpoints: 1) Difference in consumption of sedatives/opiods before and after the intervention. 2) Prevalence and duration of delirium, distress, and withdrawal syndrome in intervention group compared with the control group. 3) The number and type of mobilization activities before and after the intervention. 4) Mobilization related adverse events (safety) intervention group and control group. 5) The health status, e.g. Activities of Daily Living (ADL) and sleep after PICU discharge.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This quality improvement project aimed to change daily practice. After implementation of the early mobilization program the child’s status will be assessed daily. During morning rounds (8hr) the bedside nurse and the attending physician will discuss the child’s safety level regarding sedation level and cardiac and respiratory criteria. Distress and delirium will be measured by the caregiving nurses, because this is standard of care. According to research in adults, early mobilization activities have a positive effect on delirium, use of sedatives, and health status after ICU discharge so we expect these effects for the current intervention group as well. This current study needs to be done in this population because the lack of research about early mobilization and clinical effects in this population.
|- Main changes (audit trail)|
|- RECORD||11-dec-2017 - 4-jan-2018|