- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03673683
Sedation and Weaning in Children Requiring Invasive Mechanical Ventilation (SANDWICH)
Sedation AND Weaning in Children: the SANDWICH Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Birmingham, United Kingdom, B4 6NH
- Birmingham Women and Children's NHS Foundation Trust
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Bristol, United Kingdom, BS2 8AE
- University Hospital Bristol NHS Foundation Trust
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Cambridge, United Kingdom, CB2 0QQ
- Cambridge University Hospitals NHS Foundation Trust
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Cardiff, United Kingdom, CF14 4XW
- Cardiff and Vale University Health Board
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Leeds, United Kingdom, LS1 3EX
- Leeds Teaching Hospitals Trust
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London, United Kingdom, SW3 6NP
- Royal Brompton and Harefield NHS Foundation Trust
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London, United Kingdom, SE5 9RS
- Kings College Hospital NHS Foundation Trust
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London, United Kingdom, W2 1NY
- Imperial College Healthcare NHS Trust
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London, United Kingdom, SW17 0QT
- St George's University Hospitals NHS Foundation Trust
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London, United Kingdom, WC1 N3JH
- Great Ormond Street Hospital NHS Foundation Trust
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Newcastle, United Kingdom, NE1 4LP
- The Newcastle upon Tyne Hospitals NHS Foundation Trust
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Oxford, United Kingdom, OX3 9DU
- Oxford University Hospital NHS Foundation Trust
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Sheffield, United Kingdom, S10 2TH
- Sheffield Children's NHS Foundation Trust
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Southampton, United Kingdom, SO16 6YD
- University Hospital Southampton Foundation NHS Trust
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Co. Antrim
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Belfast, Co. Antrim, United Kingdom, BT12 6BE
- Belfast Health and Social Care Trust
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Merseyside
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Liverpool, Merseyside, United Kingdom, L12 2AP
- Alder Hey Children's NHS Foundation Trust
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Staffordshire
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Stoke, Staffordshire, United Kingdom, ST4 6QG
- University Hospitals of North Midlands NHS Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Usual Care
Sedation and ventilation weaning that is non-protocol-based and primarily medically-driven.
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Usual sedation and weaning management that is not protocol based
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Experimental: SANDWICH protocol
A protocol-based intervention for managing sedation and ventilation weaning.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of Invasive Mechanical Ventilation
Time Frame: From admission until 48 hours following extubation
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Duration of Invasive Mechanical Ventilation measured in hours from initiation of invasive mechanical ventilation until the first successful extubation
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From admission until 48 hours following extubation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Successful Extubation
Time Frame: 48 hours following extubation
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Incidence of successful extubation
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48 hours following extubation
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Number of unplanned extubations
Time Frame: From admission up to 90 days or PICU discharge whichever is earlier
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Number of unplanned extubations
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From admission up to 90 days or PICU discharge whichever is earlier
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Number of reintubations
Time Frame: From admission up to 90 days or PICU discharge whichever is earlier
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Number of reintubations
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From admission up to 90 days or PICU discharge whichever is earlier
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Total duration of Invasive mechanical ventilation
Time Frame: From admission up to 90 days or PICU discharge whichever is earlier
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Total duration of Invasive mechanical ventilation
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From admission up to 90 days or PICU discharge whichever is earlier
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Non-invasive mechanical ventilation Incidence
Time Frame: From admission up to 90 days or PICU discharge whichever is earlier
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Incidence of post-extubation use of non-invasive ventilation
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From admission up to 90 days or PICU discharge whichever is earlier
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Non-invasive mechanical ventilation Duration
Time Frame: From admission up to 90 days or PICU discharge whichever is earlier
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Duration of post-extubation use of non-invasive ventilation
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From admission up to 90 days or PICU discharge whichever is earlier
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Tracheostomy insertion
Time Frame: From admission up to 90 days or PICU discharge whichever is earlier
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Incidence of tracheostomy insertion
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From admission up to 90 days or PICU discharge whichever is earlier
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Post-extubation stridor
Time Frame: From admission up to 90 days or PICU discharge whichever is earlier
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Incidence of post-extubation stridor
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From admission up to 90 days or PICU discharge whichever is earlier
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Adverse events
Time Frame: From admission up to 90 days or PICU discharge whichever is earlier
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Incidence of adverse events
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From admission up to 90 days or PICU discharge whichever is earlier
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PICU length of stay
Time Frame: From admission up to 90 days or PICU discharge whichever is earlier
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PICU length of stay from admission to discharge measured in days
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From admission up to 90 days or PICU discharge whichever is earlier
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Hospital length of stay
Time Frame: From admission up to 90 days or PICU discharge whichever is earlier
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Hospital length of stay from admission to discharge measured in days
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From admission up to 90 days or PICU discharge whichever is earlier
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ICU Mortality
Time Frame: From admission up to 90 days or PICU discharge whichever is earlier
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Incidence of mortality occurring within the ICU
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From admission up to 90 days or PICU discharge whichever is earlier
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Hospital Mortality
Time Frame: From admission up to 90 days or PICU discharge whichever is earlier
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Incidence of Mortality occurring within the hospital
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From admission up to 90 days or PICU discharge whichever is earlier
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Cost per respiratory complication avoided
Time Frame: 28 days
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Cost per respiratory complication avoided
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28 days
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bronagh Blackwood, Queens University Belfast
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- B17/13
- 15/04/01 (Other Identifier: NIHR HTA)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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