Clinical trial NCT03673683: Sedation and Weaning in Children Requiring Invasive Mechanical Ventilation
Official title: Sedation AND Weaning in Children: the SANDWICH Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator Weaning
Keywords: Invasive Mechanical Ventilation
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
Collaborators: name: Birmingham Women's and Children's NHS Foundation Trust
name: Royal Brompton & Harefield NHS Foundation Trust
name: University College, London
name: University of Birmingham
name: University of Leeds
name: Northern Ireland Clinical Trials Unit
name: University of the West of England
name: University of Edinburgh
First posted: 2018-09-17
Enrollment: 10498
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped wedge, cluster randomized stepped wedge clinical trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of Invasive Mechanical Ventilation
timeFrame: From admission until 48 hours following extubation
Secondary outcomes:
measure: Successful Extubation
timeFrame: 48 hours following extubation
measure: Number of unplanned extubations
timeFrame: From admission up to 90 days or PICU discharge whichever is earlier
measure: Number of reintubations
timeFrame: From admission up to 90 days or PICU discharge whichever is earlier
measure: Total duration of Invasive mechanical ventilation
timeFrame: From admission up to 90 days or PICU discharge whichever is earlier
measure: Non-invasive mechanical ventilation Incidence
timeFrame: From admission up to 90 days or PICU discharge whichever is earlier
measure: Non-invasive mechanical ventilation Duration
timeFrame: From admission up to 90 days or PICU discharge whichever is earlier
measure: Tracheostomy insertion
timeFrame: From admission up to 90 days or PICU discharge whichever is earlier
measure: Post-extubation stridor
timeFrame: From admission up to 90 days or PICU discharge whichever is earlier
measure: Adverse events
timeFrame: From admission up to 90 days or PICU discharge whichever is earlier
measure: PICU length of stay
timeFrame: From admission up to 90 days or PICU discharge whichever is earlier
measure: Hospital length of stay
timeFrame: From admission up to 90 days or PICU discharge whichever is earlier
measure: ICU Mortality
timeFrame: From admission up to 90 days or PICU discharge whichever is earlier
measure: Hospital Mortality
timeFrame: From admission up to 90 days or PICU discharge whichever is earlier
measure: Cost per respiratory complication avoided
timeFrame: 28 days
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Belfast Health and Social Care Trust
state: Co. Antrim
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's NHS Foundation Trust
state: Merseyside
city: Stoke
country: United Kingdom
facility: University Hospitals of North Midlands NHS Trust
state: Staffordshire
city: Birmingham
country: United Kingdom
facility: Birmingham Women and Children's NHS Foundation Trust
city: Bristol
country: United Kingdom
facility: University Hospital Bristol NHS Foundation Trust
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: Cardiff
country: United Kingdom
facility: Cardiff and Vale University Health Board
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals Trust
city: London
country: United Kingdom
facility: Kings College Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Brompton and Harefield NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: London
country: United Kingdom
facility: Great Ormond Street Hospital NHS Foundation Trust
city: Newcastle
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospital NHS Foundation Trust
city: Sheffield
country: United Kingdom
facility: Sheffield Children's NHS Foundation Trust
city: Southampton
country: United Kingdom
facility: University Hospital Southampton Foundation NHS Trust
Study officials:
affiliation: Queens University Belfast
name: Bronagh Blackwood
role: PRINCIPAL_INVESTIGATOR
References: