Sedation and Weaning in Children Requiring Invasive Mechanical Ventilation
- Conditions
- Ventilator Weaning
- Interventions
- Behavioral: Usual careBehavioral: SANDWICH protocol
- Registration Number
- NCT03673683
- Lead Sponsor
- Queen's University, Belfast
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10498
- All children (> 16 year old) in participating PICUs receiving invasive mechanical ventilation
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Usual Care Usual care Sedation and ventilation weaning that is non-protocol-based and primarily medically-driven. SANDWICH protocol SANDWICH protocol A protocol-based intervention for managing sedation and ventilation weaning.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Successful Extubation 48 hours following extubation Incidence of successful extubation
Tracheostomy insertion From admission up to 90 days or PICU discharge whichever is earlier Incidence of tracheostomy insertion
Post-extubation stridor From admission up to 90 days or PICU discharge whichever is earlier Incidence of post-extubation stridor
ICU Mortality From admission up to 90 days or PICU discharge whichever is earlier Incidence of mortality occurring within the ICU
Cost per respiratory complication avoided 28 days Cost per respiratory complication avoided
Number of unplanned extubations From admission up to 90 days or PICU discharge whichever is earlier Number of unplanned extubations
Total duration of Invasive mechanical ventilation From admission up to 90 days or PICU discharge whichever is earlier Total duration of Invasive mechanical ventilation
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
Number of reintubations From admission up to 90 days or PICU discharge whichever is earlier Number of reintubations
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 Mortality From admission up to 90 days or PICU discharge whichever is earlier Incidence of Mortality occurring within the hospital
Trial Locations
- Locations (17)
Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
Birmingham Women and Children's NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
University Hospital Bristol NHS Foundation Trust
🇬🇧Bristol, 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
Royal Brompton and Harefield NHS Foundation Trust
🇬🇧London, United Kingdom
St George's University Hospitals NHS Foundation Trust
🇬🇧London, United Kingdom
Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom
Great Ormond Street Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
🇬🇧Newcastle, United Kingdom
Oxford University Hospital NHS Foundation Trust
🇬🇧Oxford, United Kingdom
Sheffield Children's NHS Foundation Trust
🇬🇧Sheffield, United Kingdom
University Hospital Southampton Foundation NHS Trust
🇬🇧Southampton, United Kingdom
University Hospitals of North Midlands NHS Trust
🇬🇧Stoke, Staffordshire, United Kingdom
Alder Hey Children's NHS Foundation Trust
🇬🇧Liverpool, Merseyside, United Kingdom
Belfast Health and Social Care Trust
🇬🇧Belfast, Co. Antrim, United Kingdom