Weaning children from the breathing machine in the children’s intensive care unit
| ISRCTN | ISRCTN16998143 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16998143 |
| ClinicalTrials.gov (NCT) | NCT03673683 |
| Protocol serial number | 36228 |
| Sponsor | Queen's University of Belfast |
| Funder | National Institute for Health Research |
- Submission date
- 11/12/2017
- Registration date
- 08/03/2018
- Last edited
- 27/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
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
Contact information
Scientific
Wellcome-Wolfson Institute for Experimental Medicine
Wellcome-Wolfson Building
Queen’s University Belfast
97 Lisburn Road
Belfast
BT9 7BL
United Kingdom
 ORCID ID |
0000-0002-4583-5381 |
|---|
Public
Northern Ireland Clinical Trials Unit
1st Floor Elliot Dynes
The Royal Group of Hospitals
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
| Phone | +44 (0)28 90 635794 |
|---|---|
| SANDWICH@nictu.hscni.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Process of Care, Complex Intervention |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| Scientific title | Sedation AND Weaning In CHildren: the SANDWICH trial |
| Study acronym | SANDWICH |
| Study objectives | 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(s) | East Midlands - Nottingham 1 Research Ethics Committee, 12/09/2017, ref: 17/EM/0301 |
| Health condition(s) or problem(s) studied | Acute respiratory failure |
| 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 |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
1. Incidence of successful extubation is measured through review of patient intensive care charts at 48 hours following extubation |
| Completion date | 15/05/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 9520 |
| Total final enrolment | 10498 |
| Key inclusion criteria | All invasively mechanically ventilated children < 16 years old |
| Key exclusion criteria | 1. Children who would not reach the primary endpoint Added 15/05/2019: 2. Children who are pregnant, as documented in their medical notes |
| Date of first enrolment | 05/02/2018 |
| Date of final enrolment | 14/10/2019 |
Locations
Countries of recruitment
- United Kingdom
- England
- Northern Ireland
- Wales
Study participating centres
L12 2AP
United Kingdom
BT12 6BE
United Kingdom
Birmingham
B4 6NH
United Kingdom
Bristol
BS2 8BJ
United Kingdom
London
SW3 6NP
United Kingdom
Cambridge
CB2 0QQ
United Kingdom
CF14 4XW
United Kingdom
London
WC1 N3JH
United Kingdom
SE5 9RS
United Kingdom
LS1 3EX
United Kingdom
Newcastle upon Tyne
NE1 4LP
United Kingdom
Oxford
OX3 9DU
United Kingdom
Southampton
SO16 6YD
United Kingdom
Tooting
London
SW17 0QT
United Kingdom
London
W2 1NY
United Kingdom
Staffordshire
ST4 6QG
United Kingdom
Sheffield
S10 2TH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 25/06/2021 | 25/06/2021 | Yes | No | |
| Results article | results | 03/08/2021 | 04/08/2021 | Yes | No |
| Results article | Process evaluation | 27/11/2023 | 28/11/2023 | Yes | No |
| Protocol article | protocol | 10/11/2019 | 08/12/2020 | Yes | No |
| HRA research summary | 26/07/2023 | No | No | ||
| Other publications | Secondary analysis | 23/01/2025 | 27/01/2025 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN16998143_Other unpublished result_25Jun2021.pdf
- Uploaded 25/06/2021
Editorial Notes
27/01/2025: Publication reference added.
28/11/2023: Publication reference added.
04/08/2021: Publication reference added.
25/06/2021: An unpublished results document has been uploaded as an additional file.
14/04/2021: The intention to publish date was changed from 14/10/2020 to 31/07/2021.
10/02/2021: The total final enrolment was changed from 10441 to 10498.
08/12/2020: Publication reference added.
27/11/2019: Total final enrolment number added.
15/05/2019: The following changes were made to the trial record:
1. The target number of participants was changed from 14310 to 9520.
2. The exclusion criteria were updated.
08/04/2019: The ClinicalTrials.gov number has been added.
13/11/2018: The following changes have been made:
1. The condition has been changed from "Specialty: Children, Primary sub-specialty: Anaesthesia Intensive Care and Cardiology; UKCRC code/ Disease: Generic Health Relevance/ No specific disease" to "Acute respiratory failure".
2. The condition category has been changed from Surgery to Respiratory.
22/10/2018: A public contact has been added.
