Ventilator WeaningSANDWICHNCT03673683
Sedation and Weaning in Children Requiring Invasive Mechanical Ventilation
A study testing SANDWICH protocol in people with Ventilator Weaning, run by Queen's University, Belfast at 17 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Ventilator Weaning
- What is being tested?
- SANDWICH protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,498 participants
- Where
- 17 sitesUnited Kingdom
- Study dates
- 5 Feb 2018to 10 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children (> 16 year old) in participating PICUs receiving invasive mechanical ventilation
Who cannot join
- 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
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United Kingdom17 sites
Belfast Health and Social Care Trust
Belfast, Co. Antrim, BT12 6BE
Birmingham Women and Children's NHS Foundation Trust
Birmingham, B4 6NH
University Hospital Bristol NHS Foundation Trust
Bristol, BS2 8AE
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
Cardiff and Vale University Health Board
Cardiff, CF14 4XW
Leeds Teaching Hospitals Trust
Leeds, LS1 3EX
Alder Hey Children's NHS Foundation Trust
Liverpool, Merseyside, L12 2AP
Kings College Hospital NHS Foundation Trust
London, SE5 9RS
St George's University Hospitals NHS Foundation Trust
London, SW17 0QT
Royal Brompton and Harefield NHS Foundation Trust
London, SW3 6NP
Imperial College Healthcare NHS Trust
London, W2 1NY
Great Ormond Street Hospital NHS Foundation Trust
London, WC1 N3JH
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, NE1 4LP
Oxford University Hospital NHS Foundation Trust
Oxford, OX3 9DU
Sheffield Children's NHS Foundation Trust
Sheffield, S10 2TH
University Hospital Southampton Foundation NHS Trust
Southampton, SO16 6YD
University Hospitals of North Midlands NHS Trust
Stoke, Staffordshire, ST4 6QG
About this study
Official title: Sedation AND Weaning in Children: the SANDWICH Trial
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.
Read the 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.
- Conditions
- Ventilator Weaning
- Being tested
- SANDWICH protocol, Usual care
- Keywords
- Invasive Mechanical Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SANDWICH protocolBehavioural
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
Usual careBehavioural
Usual sedation and weaning management that is not protocol based
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Sedation and ventilation weaning that is non-protocol-based and primarily medically-driven. Receives: Behavioral: Usual care |
| SANDWICH protocol | Experimental | A protocol-based intervention for managing sedation and ventilation weaning. Receives: Behavioral: SANDWICH protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Invasive Mechanical Ventilation
Duration of Invasive Mechanical Ventilation measured in hours from initiation of invasive mechanical ventilation until the first successful extubation
Measured: From admission until 48 hours following extubation
Secondary outcomes (14)
Successful Extubation
Incidence of successful extubation
Measured: 48 hours following extubation
Number of unplanned extubations
Number of unplanned extubations
Measured: From admission up to 90 days or PICU discharge whichever is earlier
Number of reintubations
Number of reintubations
Measured: From admission up to 90 days or PICU discharge whichever is earlier
Total duration of Invasive mechanical ventilation
Total duration of Invasive mechanical ventilation
Measured: From admission up to 90 days or PICU discharge whichever is earlier
Non-invasive mechanical ventilation Incidence
Incidence of post-extubation use of non-invasive ventilation
Measured: From admission up to 90 days or PICU discharge whichever is earlier
Non-invasive mechanical ventilation Duration
Duration of post-extubation use of non-invasive ventilation
Measured: From admission up to 90 days or PICU discharge whichever is earlier
Tracheostomy insertion
Incidence of tracheostomy insertion
Measured: From admission up to 90 days or PICU discharge whichever is earlier
Post-extubation stridor
Incidence of post-extubation stridor
Measured: From admission up to 90 days or PICU discharge whichever is earlier
Adverse events
Incidence of adverse events
Measured: From admission up to 90 days or PICU discharge whichever is earlier
PICU length of stay
PICU length of stay from admission to discharge measured in days
Measured: From admission up to 90 days or PICU discharge whichever is earlier
Hospital length of stay
Hospital length of stay from admission to discharge measured in days
Measured: From admission up to 90 days or PICU discharge whichever is earlier
ICU Mortality
Incidence of mortality occurring within the ICU
Measured: From admission up to 90 days or PICU discharge whichever is earlier
Hospital Mortality
Incidence of Mortality occurring within the hospital
Measured: From admission up to 90 days or PICU discharge whichever is earlier
Cost per respiratory complication avoided
Cost per respiratory complication avoided
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start5 Feb 2018
- Primary completion10 Mar 2020
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator WeaningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped wedge, cluster randomized stepped wedge clinical trial
- Masking
- None (open label)
- Enrolment
- 10,498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Bronagh Blackwood, Queen's University, Belfast
- Investigators
- Bronagh Blackwood, Principal investigator, Queens University Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673683
- Sponsor's protocol ID
- B17/13
- Other IDs
- 15/04/01
- Acronym
- SANDWICH
- Status last verified
- Mar 2020
- First submitted
- 2 Jul 2018
- Last updated
- 20 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedation AND Weaning in Children: the SANDWICH Trial
- ClinicalTrials.gov ID
- NCT03673683
- Acronym / sponsor ID
- SANDWICH / B17/13
- Conditions
- Ventilator Weaning
- Keywords
- Invasive Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,498 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- 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
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped wedge, cluster randomized stepped wedge clinical trial
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Usual careSedation and ventilation weaning that is non-protocol-based and primarily medically-driven. |
| SANDWICH protocol | Experimental | Behavioral: SANDWICH protocolA protocol-based intervention for managing sedation and ventilation weaning. |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All children (> 16 year old) in participating PICUs receiving invasive mechanical ventilation
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SANDWICH protocolA 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 | Behavioural | SANDWICH protocol |
| Usual careUsual sedation and weaning management that is not protocol based | Behavioural | Usual Care |
Primary outcome
Duration of Invasive Mechanical Ventilation
Time frame: 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
14 secondary outcomes
Successful Extubation
Time frame: 48 hours following extubation
Number of unplanned extubations
Time frame: From admission up to 90 days or PICU discharge whichever is earlier
Number of reintubations
Time frame: From admission up to 90 days or PICU discharge whichever is earlier
Total duration of Invasive mechanical ventilation
Time frame: From admission up to 90 days or PICU discharge whichever is earlier
Non-invasive mechanical ventilation Incidence
Time frame: From admission up to 90 days or PICU discharge whichever is earlier
Non-invasive mechanical ventilation Duration
Time frame: From admission up to 90 days or PICU discharge whichever is earlier
Tracheostomy insertion
Time frame: From admission up to 90 days or PICU discharge whichever is earlier
Post-extubation stridor
Time frame: From admission up to 90 days or PICU discharge whichever is earlier
Adverse events
Time frame: From admission up to 90 days or PICU discharge whichever is earlier
PICU length of stay
Time frame: From admission up to 90 days or PICU discharge whichever is earlier
Hospital length of stay
Time frame: From admission up to 90 days or PICU discharge whichever is earlier
ICU Mortality
Time frame: From admission up to 90 days or PICU discharge whichever is earlier
Hospital Mortality
Time frame: From admission up to 90 days or PICU discharge whichever is earlier
Cost per respiratory complication avoided
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bronagh Blackwood principal investigator
Queens University Belfast
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SANDWICH protocol in people with Ventilator Weaning, run by Queen's University, Belfast at 17 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Invasive Mechanical Ventilation (time frame: From admission until 48 hours following extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2020.