Ventilator Weaning
Conditions
Keywords
Invasive Mechanical Ventilation
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSANDWICH protocol
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
BEHAVIORALUsual care
Usual sedation and weaning management that is not protocol based
Sponsors
Birmingham Women's and Children's NHS Foundation Trust
Royal Brompton & Harefield NHS Foundation Trust
University College, London
University of Birmingham
University of Leeds
Northern Ireland Clinical Trials Unit
University of the West of England
University of Edinburgh
Queen's University, Belfast
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Stepped wedge, cluster randomized stepped wedge clinical trial
Eligibility
Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No
Inclusion criteria
* All children (\> 16 year old) in participating PICUs receiving invasive mechanical ventilation
Exclusion criteria
* Children who would not reach the primary endpoint (tracheostomy in situ; not expected to survive; treatment withdrawal) * Children who are pregnant, as documented in their medical notes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Invasive Mechanical Ventilation | From admission until 48 hours following extubation | Duration of Invasive Mechanical Ventilation measured in hours from initiation of invasive mechanical ventilation until the first successful extubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of unplanned extubations | From admission up to 90 days or PICU discharge whichever is earlier | Number of unplanned extubations |
| Number of reintubations | From admission up to 90 days or PICU discharge whichever is earlier | Number of reintubations |
| Total duration of Invasive mechanical ventilation | From admission up to 90 days or PICU discharge whichever is earlier | Total duration of Invasive mechanical ventilation |
| Non-invasive mechanical ventilation Incidence | From admission up to 90 days or PICU discharge whichever is earlier | Incidence of post-extubation use of non-invasive ventilation |
| Non-invasive mechanical ventilation Duration | From admission up to 90 days or PICU discharge whichever is earlier | Duration of post-extubation use of non-invasive ventilation |
| Tracheostomy insertion | From admission up to 90 days or PICU discharge whichever is earlier | Incidence of tracheostomy insertion |
| Successful Extubation | 48 hours following extubation | Incidence of successful extubation |
| Adverse events | From admission up to 90 days or PICU discharge whichever is earlier | Incidence of adverse events |
| PICU length of stay | From admission up to 90 days or PICU discharge whichever is earlier | PICU length of stay from admission to discharge measured in days |
| Hospital length of stay | From admission up to 90 days or PICU discharge whichever is earlier | Hospital length of stay from admission to discharge measured in days |
| ICU Mortality | From admission up to 90 days or PICU discharge whichever is earlier | Incidence of mortality occurring within the ICU |
| Hospital Mortality | From admission up to 90 days or PICU discharge whichever is earlier | Incidence of Mortality occurring within the hospital |
| Cost per respiratory complication avoided | 28 days | Cost per respiratory complication avoided |
| Post-extubation stridor | From admission up to 90 days or PICU discharge whichever is earlier | Incidence of post-extubation stridor |
Countries
United Kingdom
Outcome results
None listed