title: A randomised controlled trial of weaning from mechanical ventilation in paediatric intensive care (PIC). Methodological and practical issues.
abstract: BACKGROUND
  Most children admitted to the Paediatric Intensive Care Unit (PICU) require assistance with breathing via a mechanical ventilator. Weaning from mechanical ventilation is the transition from ventilatory support to spontaneous breathing. Traditionally weaning has been with the authority of the medical staff. However, current opinion suggests that weaning could be performed by nurses using a standardised protocol [Schultz TR, Lin RJ, Watzman HM, Durning SM, Hales R, Woodson A, et al. Weaning children from mechanical ventilation: A prospective randomised trial of protocol-directed versus physician-directed weaning. Respir Care 2001;46(8):772-82]. The potential advantages of nurse-led (protocol-directed) weaning include: A reduction in weaning time and PICU stay with cost savings. Reduced complications. Improved quality of care. Appropriate use of resources.
  
  
  METHODS
  A Randomised Controlled Trial was performed to test the null hypothesis: there is no difference between the clinical effectiveness of nurse-led versus medical-led weaning of infants from mechanical ventilation. Data was collected for 7 infants and analysed.
  
  
  RESULTS
  Results indicated no significant differences between the two study groups. Unfortunately due to recruitment problems few inferences can be drawn from the data.
  
  
  CONCLUSIONS
  The trial was unsuccessful due to Recruitment issues. Physical constraints. Impractical entry criteria. Limited randomisation service. Ethical constraints. Barriers to parental participation. The methods, the difficulties encountered and the implications for future research are addressed.
authors.affiliation: Regional Research Nurse, The General Infirmary at Leeds, Great George Street, Leeds, West Yorkshire LS1 3EX, UK. Kay.Rushforth@leedsth.nhs.uk
authors.forename: Kay
authors.initials: K
authors.lastname: Rushforth
mesh_terms: D000465:Algorithms; D002985:Clinical Protocols; D003422:Critical Care / Q000379:methods* / Q000592:standards; D003663:Decision Trees; D004509:Education, Nursing, Continuing; D004739:England; D005260:Female; D006784:Hospitals, Teaching; D006801:Humans; D007223:Infant; D007318:Inservice Training; D015278:Intensive Care Units, Pediatric; D007902:Length of Stay / Q000706:statistics & numerical data; D008297:Male; D024802:Nurse's Role; D015403:Nursing Evaluation Research; D009741:Nursing Staff, Hospital / Q000193:education / Q000458:organization & administration; D017410:Practice Guidelines as Topic; D017009:Professional Autonomy; D012107:Research Design; D013997:Time Factors; D015300:Ventilator Weaning / Q000379:methods / Q000451:nursing* / Q000592:standards