Ventilator Weaning Clinical Trial
Official title:
Sedation AND Weaning in Children: the SANDWICH Trial
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.
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