Condition category
Surgery
Date applied
11/12/2017
Date assigned
08/03/2018
Last edited
22/10/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
A mechanical ventilator is a machine that helps people breathe when they are not able to breathe enough on their own. A new protocol has been developed for getting children off the ventilator (known as weaning). It is a series of steps that the care team need to follow and involves using a tool called the COMFORT scale to assess whether the sedation a child is receiving is suitable for them. It also includes using information from the ventilator to assess when it is time to check if the patient can come off the ventilator (extubation). In order to check whether the patient can come off the ventilator the protocol includes steps to check how well a child is able to breathe for themselves (while they are still on the ventilator). If this shows the patient is ready to come off the ventilator, the child is extubated using the PICU’s usual practice (by trained clinical staff who are normally responsible for this). The aim of this study is to find out whether the new protocol can reduce the duration of mechanical ventilation and is cost effective compared with usual care.

Who can participate?
Children aged under 16 who are on ventilators in up to 18 Paediatric Intensive Care Units (PICUs) across the UK

What does the study involve?
At the start of the study, all PICUs continue to follow their current usual care practices for trying to get children off the ventilator (known as weaning). This is referred to as the 'control period'. Every month a PICU is randomly allocated to introduce the new protocol to try to get children off the ventilator as soon as it is safe to do so. Both doctors and nurses are involved in the steps to assess whether a child is ready to come off the ventilator. To help introduce this new approach to weaning and sedation, staff in PICUs are trained on what they have to do. An experienced nurse goes to all of the PICUs and trains a core team of staff (including the person who is normally responsible for arranging training for everyone). These staff subsequently arrange training for the other medical and nursing staff in their unit. The PICUs are also given training manuals and there is a training course that nurses and doctors can complete on the internet. All participating PICUs routinely collect data into a database known as PICANet which is used to find out the best ways to treat and care for children. This study uses data collected by PICANet. In addition, other data is taken from patient’s charts and medical notes and entered into a secure database by a member of the team who works for the PICU.

What are the possible benefits and risks of participating?
The protocol may lead to a benefit of a reduction in time on mechanical ventilation. During the spontaneous breathing test the patient may experience signs of respiratory distress. They will be monitored closely throughout by the clinical team and if there are signs of respiratory distress, patients will be returned to invasive mechanical ventilation.

Where is the study run from?
1. Alder Hey Children's Hospital (UK)
2. Royal Belfast Hospital for Sick Children (UK)
3. Birmingham Children’s Hospital (UK)
4. Bristol Royal Children's Hospital (UK)
5. Royal Brompton Hospital (UK)
6. Addenbrooke's Hospital (UK)
7. Noah's Ark Children's Hospital for Wales (UK)
8. Great Ormond Street Hospital (UK)
9. Variety Children's Hospital (UK)
10. Leeds General Infirmary (UK)
11. Royal Victoria Infirmary (UK)
12. John Radcliffe Hospital (UK)
13. Southampton General Hospital (UK)
14. St George’s Hospital (UK)
15. St Mary’s Hospital (UK)
16. Royal Stoke University Hospital (UK)
17. Sheffield Children's Hospital (UK)

When is the study starting and how long is it expected to run for?
April 2017 to May 2020

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Prof. Bronagh Blackwood

Trial website

www.nictu.hscni.net/sandwich-trial

Contact information

Type

Scientific

Primary contact

Prof Bronagh Blackwood

ORCID ID

http://orcid.org/0000-0002-4583-5381

Contact details

Wellcome-Wolfson Institute for Experimental Medicine
Wellcome-Wolfson Building
Queen’s University Belfast
97 Lisburn Road
Belfast
BT9 7BL
United Kingdom

Type

Public

Additional contact

Ms Roisin Boyle

ORCID ID

Contact details

Northern Ireland Clinical Trials Unit
1st Floor Elliot Dynes
The Royal Group of Hospitals
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
+44 (0)28 90 635794
SANDWICH@nictu.hscni.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

36228

Study information

Scientific title

Sedation AND Weaning In CHildren: the SANDWICH trial

Acronym

SANDWICH

Study hypothesis

Cluster-randomised stepped wedge (SW) clinical and cost-effectiveness trial with an internal pilot and a process evaluation (PE), to determine if a protocol-based intervention, incorporating co-ordinated care with greater nursing involvement, to manage sedation and ventilator weaning can reduce the duration of invasive mechanical ventilation and is cost effective compared with usual care in children in Paediatric Intensive Care Units.

Ethics approval

East Midlands - Nottingham 1 Research Ethics Committee, 12/09/2017, ref: 17/EM/0301

Study design

Randomised; Interventional; Design type: Process of Care, Complex Intervention

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Specialty: Children, Primary sub-specialty: Anaesthesia Intensive Care and Cardiology; UKCRC code/ Disease: Generic Health Relevance/ No specific disease

Intervention

This study will be conducted in up to 18 Paediatric Intensive Care Units (PICUs) across the UK. Each PICU will be considered a 'cluster' in this trial. All clusters will open and start the trial at the same time. At the beginning of the study, all clusters will continue to follow their current usual care practices for trying to get children off the ventilator (known as weaning). This is referred to as the 'control period'.

Every month a PICU will be randomized to the 'intervention'. The intervention involves the introduction of a new structured approach by a child's care team to try to get them off the ventilator as soon as it is safe to do so. Both doctors and nurses will be involved in the steps to assess whether a child is ready to come off the ventilator.

The Chief Investigator (CI) for the study gathered together a group of doctors and nurses from PICUs across the UK to get their advice on ways to improve how weaning and sedation is managed. Using the feedback from this meeting, the CI and other investigators involved in the study (consultants and nurses who work in PICUs) developed a 'protocol' for weaning. The protocol is a description of the steps that the care team need to follow. It involves using a tool called the
COMFORT scale to assess if the sedation a child is receiving is suitable for them. It also includes using information from the ventilator to assess when it is time to check if the patient can come off the ventilator (extubation). In order to check if the patient can come off the ventilator the protocol includes steps to check how well a child is able to breath for themselves (while they are still on the ventilator). If this shows the patient is ready to come off the ventilator, the child will be extubated using the PICUs usual practice (by trained clinical staff who are normally responsible for this).

To help introduce this new approach to weaning and sedation, staff in PICUs will be trained on what they have to do. An experienced nurse, who is part of the CI's team, will go to all of the PICUs and train a core team of staff (including the person who is normally responsible for arranging training for everyone). These staff will subsequently arrange training for the other medical and nursing staff in their unit. The PICUs will also be given training manuals and there will be a training course that nurses and doctors can complete on the internet.

At any one time in any unit, the same approach to weaning (usual-care or the new approach) will be followed for all mechanically ventilated children. For this reason, and because it is a low risk trial, a non-confirmed deemed consent (opt-out) approach will be taken. Leaflets will be provided to parents of children, informing them that the PICU is involved in a study and that staff will be collecting anonymised patient level information during that time. Staff will not ask parent/guardians to confirm that they consent for their child’s information to be used in the trial. The leaflets provided to parents will include details of who can be contacted to get more information or to ask that any information collected about their child is not included in the data analysis. Posters will also be displayed in prominent areas to raise awareness that the PICU is conducting a trial.

All participating PICUs routinely collect data into a database known as PICANet which is used to find out the best ways to treat and care for children. The SANDWICH trial will use data collected by PICANet. In addition, other data needed for the trial will be taken from patient’s charts and medical notes and entered into a secure database by a member of the team who works for the PICU. No identifiable information will be collected or used during the trial.

Data will be collected, and included in data analysis, for all children admitted to participating PICUs except those who are expected to be on the ventilator for an indefinite length of time, and those whose parents/guardians opt-out of data collection. The number of children not included in the data analysis, and the reason why, will be recorded.

When PICUs are randomised to the intervention they will be given 2 months to prepare e.g. time to organise when staff will be available to complete their training. During the next 2 months staff will receive training on the intervention, after which, all staff at the PICU should follow the new approach to weaning; they will continue using the new approach for the rest of the trial.

The trial will also include a Process Evaluation (PE). PICU staff, who are involved in either implementing the training or delivering the intervention, will be approached by members of their local research team (Principal Investigator [PI], research nurse or champion), and invited to participate in the PE.

Participants will be chosen to ensure participation from a range of staff grades and professions. They will be provided with a written information leaflet which outlines the purpose of the research, what it involves, the benefits and whom they can contact if they require additional information. Staff will be given at least 24 hour to consider whether they wish to participate or not. The PE Researcher will subsequently contact those staff willing to participate in the PE to organise
individual and/or focus group interviews. Fully informed written consent will be obtained.

Initial PE visits will be scheduled in the months just prior to PICU training on the intervention. These interviews will establish the context and usual practice at each unit. During the final months of the study, the PE will explore with staff the factors that helped or hindered how well the quality improvement plan was delivered, implemented and embedded in units.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Duration of Invasive Mechanical Ventilation measured in hours through review of patient Intensive care charts from initiation of invasive ventilation until successful extubation (success defined as still breathing spontaneously 48 hours following extubation); Timepoint(s): 48 hours

Secondary outcome measures

1. Incidence of successful extubation is measured through review of patient intensive care charts at 48 hours following extubation
2. Number of unplanned extubations is measured through review of patient intensive care charts up to 90 days or PICU discharge
3. Number of reintubations is measured through review of patient intensive care charts up to 90 days or PICU discharge
4. Total duration of Invasive Mechanical Ventilation in hours through review of patient intensive care charts up to 90 days or discharge
5. Incidence and duration in minutes of post extubation use of non-invasive ventilation is measured through review of patient intensive care charts up to 90 days or PICU discharge
6. Incidence of tracheostomy insertion is measured through review of patient intensive care charts at 90 days or PICU discharge
7. Incidence of post-extubation Stridor is measured through review of patient intensive care charts at 90 days or PICU discharge
8. Incidence of any adverse events is measured through review of patient notes at 90 days or PICU discharge
9. PICU length of stay is measured in days through review of patient notes at PICU discharge
10. Hospital length of stay discharge is measured in days through review of patients notes at hospital discharge
11. Incidence of mortality in ICU is measured through review of the PICAnet data set at PICU discharge
12. Incidence of mortality in hospital is measured through review of patients notes at hospital discharge
13. Cost per complication avoided is measured through review of patients notes and the PICAnet dataset at 28 days

Overall trial start date

01/04/2017

Overall trial end date

15/05/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

All invasively mechanically ventilated children < 16 years old

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 14310; UK Sample Size: 14310

Participant exclusion criteria

Children who would not reach the primary endpoint

Recruitment start date

05/02/2018

Recruitment end date

14/10/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Alder Hey Children's Hospital
Liverpool
L12 2AP
United Kingdom

Trial participating centre

Royal Belfast Hospital for Sick Children
Belfast
BT12 6BE
United Kingdom

Trial participating centre

Birmingham Children’s Hospital
Steelhouse Lane
Birmingham
B4 6NH
United Kingdom

Trial participating centre

Bristol Royal Children's Hospital
Upper Maudlin Street
Bristol
BS2 8BJ
United Kingdom

Trial participating centre

Royal Brompton Hospital
Sydney Street
London
SW3 6NP
United Kingdom

Trial participating centre

Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Trial participating centre

Noah's Ark Children's Hospital for Wales
Cardiff
CF14 4XW
United Kingdom

Trial participating centre

Great Ormond Street Hospital
Great Ormond Street
London
WC1 N3JH
United Kingdom

Trial participating centre

Variety Children's Hospital
King's College Hospital
SE5 9RS
United Kingdom

Trial participating centre

Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom

Trial participating centre

Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Trial participating centre

John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom

Trial participating centre

Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Trial participating centre

St George’s Hospital
Blackshaw Road Tooting
London
SW17 0QT
United Kingdom

Trial participating centre

St Mary’s Hospital
Praed Street
London
W2 1NY
United Kingdom

Trial participating centre

Royal Stoke University Hospital
Newcastle Road
Staffordshire
ST4 6QG
United Kingdom

Trial participating centre

Sheffield Children's Hospital
Western Bank
Sheffield
S10 2TH
United Kingdom

Sponsor information

Organisation

Queen's University of Belfast

Sponsor details

63 University Road
Belfast
BT7 1NN
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

1. Dissemination to the UK paediatric intensive care community:
1.1. We will provide an ongoing update during the trial on a dedicated trial website and at the Paediatric Intensive Care Society (PICS) Study Group meetings.
1.2. As the success of the trial depends largely on the collaboration of doctors, nurses and researchers from across study sites, we will first report the results of the trial to trial collaborators.
1.3. We will report the study in accordance with the CONSORT statement extension for stepped wedge cluster trials and the TIDieR checklist and guide.
2. Wider dissemination to the paediatric intensive care community:
2.1. We will publish the trial protocol and statistical analysis plan to ensure transparency in our methodology.
2.2. Findings will be presented at national and international meetings with abstracts on-line. Presentations will ensure that the results and their implications quickly reach the PICU community and this will be facilitated by our investigator team that includes clinicians and researchers in senior positions.
2.3. In accordance with open access policies proposed by the NIHR we will publish the clinical findings of the trial as well as a paper describing the cost-effectiveness in the NHS setting in high quality peer-reviewed open access (via PubMed) journals. This will secure a searchable compendium of these publications and make the results readily accessible to the public, health care professionals and scientists.
2.4. A final report will also be published in the NIHR HTA journal.
2.5. We plan to actively promote study findings to journal editors and critical care opinion leaders to ensure the findings are widely disseminated (e.g. through editorials and conference presentations) and included in future guidelines.
3. Dissemination to the NHS:
3.1. We will inform NHS managers and commissioners if the study supports a change of practice.
4. Dissemination to the public:
4.1. With help from our lay representatives, we will write a lay person’s summary and distribute it to national parent support and liaison groups, notably the PICS Families group and Baby ICUsteps.
4.2. We will send a report of the study findings to the INVOLVE registry. This is an open-access database which registers research health care projects involving members of the public as partners in the research process.
4.3. Following peer reviewed publication relevant key findings will be posted on institutional websites available to the general public.
4.4. In addition, the most significant results will be communicated through press releases to ensure dissemination to the broader public and research participants.

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Intention to publish date

14/10/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

22/10/2018: A public contact has been added.