Major UK trial dramatically improves outcomes for critically ill children on mechanical ventilation: A major UK clinical trial led by Queen’s University Belfast has shown how a novel approach to reduce ventilation use mechanics can dramatically improve outcomes for critically ill infants and children.
The study, funded by the Health Technology Program of the National Institute for Health Research (NIHR), found that greater involvement of nurses, minimization of sedation use, and increased daily tests to assess the child’s readiness to exit the ventilator significantly reduced mechanical ventilation time. . It is the largest trial of its kind and has already led to practice changes for two-thirds of UK pediatric intensive care units to benefit infants and children.
Clinical trial leader Bronagh Blackwood, professor of intensive care at the Wellcome-Wolfson Institute for Experimental Medicine at Queen’s University Belfast, said: “To minimize the risks associated with mechanical ventilation, the earlier children are weaned from the ventilator, the better their results.
“We have shown that nurse-led care, with daily screening to test readiness to exit the ventilator and reduced sedation, is safe and dramatically improves their chances of exiting the ventilator sooner than before.”
Each year in the UK around 20,000 infants and children are treated in a pediatric intensive care unit and of these around 12,000 receive mechanical ventilation. Mechanical ventilation is a life-saving therapy, but it may involve a related risk from the breathing tube in the mouth and throat, the sedative drugs needed to reduce anxiety, and being confined to bed.
Sedation AND weaning in children (SANDWICH) is the world’s largest trial recruiting infants and children to pediatric intensive care units (ICUs). The study looked at more than 10,000 admissions to 18 intensive care units, representing two-thirds of pediatric intensive care units in the UK.
The results were published in the Journal of American Medical Association.
Compared to current standard care, the study reported that in children who needed to be on a ventilator for more than 24 hours, the intervention reduced the time spent on a mechanical ventilator by an average of six hours. In addition, in all children, whether they were supposed to be on a ventilator for more or less than 24 hours, the procedure reduced ventilation time by an average of seven hours. Overall, the odds of children having their breathing tubes removed successfully were greater.
Professor Mark Peters, Critical Care Consultant at GOSH and Professor of Pediatric Critical Care at UCL Great Ormond Street Institute of Child Health, a major research partner, said: “This is the largest randomized controlled trial ever undertaken in pediatric intensive care with over 10,000 critically ill children participating – nearly 2,000 children in GOSH alone.
“To improve the care of the sickest children in our hospitals, pediatric intensive care teams from across the UK have come together to put bedside nursing at the heart of decision-making and introduce a more structured to reduce sedatives and ventilation.
“This trial redefines what is doable in pediatric intensive care research.”
The trial involved training over 2,000 doctors and nurses in the new SANDWICH intervention. This has resulted in a change in practice for two-thirds of UK pediatric intensive care units to benefit infants and children. The success of this quality improvement intervention in the evolution of medical and nursing practice is of great significance to other pediatric intensive care units around the world.
Partners include: Alder Hey Hospital; Birmingham Children’s Hospital; Great Ormond Street Hospital; Royal Brompton Hospital; the University of Birmingham; University College of London; University of Edinburgh; University of Leeds; University of Salford and the Northern Ireland Clinical Trials Unit.