A UK multi-centre cluster randomised controlled trial to determine if a protocol-based intervention incorporating coordinated care with greater nursing involvement to managing sedation and ventilator weaning can reduce the duration of invasive mechanical ventilation and is cost effective compared with usual care in children in Pediatric Intensive Care Units.
Mechanical ventilation is a common lifesaving therapy, but the longer a child remains on the ventilator, the more risk they have of developing problems. For this reason, getting the child off the ventilator (called weaning) is an important patient outcome. Sedative drugs are necessary so the child can tolerate the breathing tube, but too much can make them sleepy and delay coming off the ventilator. In 2014, visits to 24 Paediatric Intensive Care Units (PICUs) were conducted and it was found that weaning was usually performed by doctors and occasionally senior nurses, but weaning was not always done the same way and, because everyone was not involved, it was often disjointed. This study will determine if a coordinated approach by doctors and nurses to optimise sedation and weaning using guidelines will: (a) reduce how long patients are on a ventilator without causing any increased risk; (b) reduce the time children spend in a PICU and the hospital; (c) be cost effective in the NHS; and (d) be easily adopted by staff delivering care. Children receiving ventilation, except those that will never come off a ventilator, will be weaned using the guidelines. Data collection will start in all PICUs at the same time from the very beginning of the study when they are weaning children according to usual practice. Each month, one unit will be chosen at random and staff will be trained to use the new guidelines. The unit will continue using the new guidelines for the rest of the trial. Outcome data collected before (usual care) and after (intervention) training will be compared. An evaluation of the process of implementing the new intervention will be undertaken. During the process evaluation, study staff will be interviewed about their experiences and views with the new approach.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
10,498
A protocol based intervention incorporating co-ordinated care with greater nursing involvement; patient-relevant sedation plans linked to regular assessment using the COMFORT scale; regular assessment of ventilation parameters with a higher than usual trigger for undertaking an extubation readiness test; a spontaneous breathing trial (SBT) on low levels of respiratory support to test extubation readiness
Usual sedation and weaning management that is not protocol based
Belfast Health and Social Care Trust
Belfast, Co. Antrim, United Kingdom
Alder Hey Children's NHS Foundation Trust
Liverpool, Merseyside, United Kingdom
Duration of Invasive Mechanical Ventilation
Duration of Invasive Mechanical Ventilation measured in hours from initiation of invasive mechanical ventilation until the first successful extubation
Time frame: From admission until 48 hours following extubation
Successful Extubation
Incidence of successful extubation
Time frame: 48 hours following extubation
Number of unplanned extubations
Number of unplanned extubations
Time frame: From admission up to 90 days or PICU discharge whichever is earlier
Number of reintubations
Number of reintubations
Time frame: From admission up to 90 days or PICU discharge whichever is earlier
Total duration of Invasive mechanical ventilation
Total duration of Invasive mechanical ventilation
Time frame: From admission up to 90 days or PICU discharge whichever is earlier
Non-invasive mechanical ventilation Incidence
Incidence of post-extubation use of non-invasive ventilation
Time frame: From admission up to 90 days or PICU discharge whichever is earlier
Non-invasive mechanical ventilation Duration
Duration of post-extubation use of non-invasive ventilation
Time frame: From admission up to 90 days or PICU discharge whichever is earlier
Tracheostomy insertion
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University Hospitals of North Midlands NHS Trust
Stoke, Staffordshire, United Kingdom
Birmingham Women and Children's NHS Foundation Trust
Birmingham, United Kingdom
University Hospital Bristol NHS Foundation Trust
Bristol, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Cardiff and Vale University Health Board
Cardiff, United Kingdom
Leeds Teaching Hospitals Trust
Leeds, United Kingdom
Kings College Hospital NHS Foundation Trust
London, United Kingdom
St George's University Hospitals NHS Foundation Trust
London, United Kingdom
...and 7 more locations
Incidence of tracheostomy insertion
Time frame: From admission up to 90 days or PICU discharge whichever is earlier
Post-extubation stridor
Incidence of post-extubation stridor
Time frame: From admission up to 90 days or PICU discharge whichever is earlier
Adverse events
Incidence of adverse events
Time frame: From admission up to 90 days or PICU discharge whichever is earlier
PICU length of stay
PICU length of stay from admission to discharge measured in days
Time frame: From admission up to 90 days or PICU discharge whichever is earlier
Hospital length of stay
Hospital length of stay from admission to discharge measured in days
Time frame: From admission up to 90 days or PICU discharge whichever is earlier
ICU Mortality
Incidence of mortality occurring within the ICU
Time frame: From admission up to 90 days or PICU discharge whichever is earlier
Hospital Mortality
Incidence of Mortality occurring within the hospital
Time frame: From admission up to 90 days or PICU discharge whichever is earlier
Cost per respiratory complication avoided
Cost per respiratory complication avoided
Time frame: 28 days