Ventilator Weaning Clinical Trial
— SANDWICHOfficial title:
Sedation AND Weaning in Children: the SANDWICH Trial
Verified date | March 2020 |
Source | Queen's University, Belfast |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10498 |
Est. completion date | March 10, 2020 |
Est. primary completion date | March 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 16 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Belfast Health and Social Care Trust | Belfast | Co. Antrim |
United Kingdom | Birmingham Women and Children's NHS Foundation Trust | Birmingham | |
United Kingdom | University Hospital Bristol NHS Foundation Trust | Bristol | |
United Kingdom | Cambridge University Hospitals NHS Foundation Trust | Cambridge | |
United Kingdom | Cardiff and Vale University Health Board | Cardiff | |
United Kingdom | Leeds Teaching Hospitals Trust | Leeds | |
United Kingdom | Alder Hey Children's NHS Foundation Trust | Liverpool | Merseyside |
United Kingdom | Great Ormond Street Hospital NHS Foundation Trust | London | |
United Kingdom | Imperial College Healthcare NHS Trust | London | |
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 | 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 |
Lead Sponsor | Collaborator |
---|---|
Queen's University, Belfast | Birmingham Women's and Children's NHS Foundation Trust, Northern Ireland Clinical Trials Unit, Royal Brompton & Harefield NHS Foundation Trust, University College, London, University of Birmingham, University of Edinburgh, University of Leeds, University of the West of England |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of Invasive Mechanical Ventilation | Duration of Invasive Mechanical Ventilation measured in hours from initiation of invasive mechanical ventilation until the first successful extubation | From admission until 48 hours following extubation | |
Secondary | Successful Extubation | Incidence of successful extubation | 48 hours following extubation | |
Secondary | Number of unplanned extubations | Number of unplanned extubations | From admission up to 90 days or PICU discharge whichever is earlier | |
Secondary | Number of reintubations | Number of reintubations | From admission up to 90 days or PICU discharge whichever is earlier | |
Secondary | Total duration of Invasive mechanical ventilation | Total duration of Invasive mechanical ventilation | From admission up to 90 days or PICU discharge whichever is earlier | |
Secondary | Non-invasive mechanical ventilation Incidence | Incidence of post-extubation use of non-invasive ventilation | From admission up to 90 days or PICU discharge whichever is earlier | |
Secondary | Non-invasive mechanical ventilation Duration | Duration of post-extubation use of non-invasive ventilation | From admission up to 90 days or PICU discharge whichever is earlier | |
Secondary | Tracheostomy insertion | Incidence of tracheostomy insertion | From admission up to 90 days or PICU discharge whichever is earlier | |
Secondary | Post-extubation stridor | Incidence of post-extubation stridor | From admission up to 90 days or PICU discharge whichever is earlier | |
Secondary | Adverse events | Incidence of adverse events | From admission up to 90 days or PICU discharge whichever is earlier | |
Secondary | PICU length of stay | PICU length of stay from admission to discharge measured in days | From admission up to 90 days or PICU discharge whichever is earlier | |
Secondary | Hospital length of stay | Hospital length of stay from admission to discharge measured in days | From admission up to 90 days or PICU discharge whichever is earlier | |
Secondary | ICU Mortality | Incidence of mortality occurring within the ICU | From admission up to 90 days or PICU discharge whichever is earlier | |
Secondary | Hospital Mortality | Incidence of Mortality occurring within the hospital | From admission up to 90 days or PICU discharge whichever is earlier | |
Secondary | Cost per respiratory complication avoided | Cost per respiratory complication avoided | 28 days |
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