A feasibility study of no routine gastric residual volume measurement in mechanically ventilated Infants and children: the GASTRIC Study
| ISRCTN | ISRCTN42110505 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42110505 |
| Protocol serial number | HTA 16/94/02 |
| Sponsor | University Hospitals Bristol |
| Funder | Health Technology Assessment Programme |
- Submission date
- 15/02/2018
- Registration date
- 16/02/2018
- Last edited
- 23/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
In intensive care units (ICUs) the amount of fluid in a child or baby’s stomach (gastric residual volume (GRV)) is regularly measured to help decide if a child is ready to have the feed into their stomach. This fluid is measured by sucking it out via a tube already into the child’s stomach. This is a very common practice in ICUs in the UK, but it is unclear if this practice is helpful. Measuring GRV may prevent problems from overfeeding when the bowel cannot cope with milk and is not absorbing feeds. In children, the main problem is vomiting of the stomach contents, and breathing this fluid into the lungs. The main worry in babies under a month old is a very serious infection of the bowel (necrotising enterocolitis). This nursing practice is heavily based on tradition and perceived risk, but benefits have not been proven and it may be harmful as feeds are often stopped, reducing the calories that babies and children receive. Ensuring that babies and children have adequate feed is vital in intensive care, and not doing so slows recovery. It is known that inadequate nutrition is common in babies and children in ICUs and measuring GRV may be contributing to this. It is thought that all children’s and baby’s ICUs (PICU and NICUs) in the UK measure GRV routinely. Before changing practice in the UK, it is necessary to undertake a study to determine the benefits and safety of not measuring GRV. The aim of this study is to find out whether it is possible to conduct a study of not measuring GRV in UK PICU and NICUs.
Who can participate?
Healthcare professionals working in UK PICU and NICUs who are involved in decision-making around feeding (nurses, doctors and dieticians), and parents of children who have been in a UK PICU or NICU
What does the study involve?
Parents’ and healthcare professionals’ views around this practice are collected using questionnaires, focus groups and interview. Parents are asked whether this is important to them and whether they would be happy for their child to take part. There is one questionnaire (at 1 month) of existing practice, then a further questionnaire about the best study design at month 4.
What are the possible benefits and risks of participating?
For staff there may be benefits in terms of engagement and involvement in the development of a future study. There are no risks except the time burden of participation.
Where is the study run from?
Liverpool Clinical Trials Research Unit (UK)
When is the study starting and how long is it expected to run for?
April 2018 to September 2019
Who is funding the study?
NIHR Health Technology Assessment Programme (UK)
Who is the main contact?
Dr Lyvonne Tume
lyvonne.tume@uwe.ac.uk
Contact information
Scientific
Faculty of Health & Applied Sciences
Glenside Campus
Blackberry Hill
Bristol
BS16 1DD
United Kingdom
 ORCID ID |
0000-0002-2547-8209 |
|---|---|
| Phone | +44 (0)1173286828 |
| lyvonne.tume@uwe.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Mixed methods feasibility study |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | A feasibility study of no routine gastric residual volume measurement in mechanically ventilated Infants and children: the GASTRIC Study |
| Study acronym | GASTRIC |
| Study objectives | To determine if it is possible to conduct a trial of not measuring gastric residual volume (GRV) in UK pediatric and neonatal intensive care units. |
| Ethics approval(s) | South West Central (Bristol) committee - approval pending |
| Health condition(s) or problem(s) studied | Critically ill tube fed neonates and children |
| Intervention | This feasibility study will examine clinician and parent views around a trial of not undertaking this routine intervention of GRV measurement and once trial inclusion/exclusion criteria are agreed then feasibility in terms of number of patients meeting these criteria nationally. The questionnaires are currently being developed as no existing tools are suitable. There will be one baseline measurement (at 1 month) of existing practice, then a further questionnaire around optimal research design at month 4. For survey 1 a per-unit response is required (29 PICUs and 192 NICUs) so a 70% unit response rate is anticipated. For survey 2, this will be larger and sent to around 600 PICU staff and 600 NICU staff around the UK. Four focus groups will take place across the UK and around 20-30 parents will be interviewed across the UK. |
| Intervention type | Other |
| Primary outcome measure(s) |
Possibility of conducting a trial of not measuring gastric residual volume (GRV) in UK pediatric and neonatal intensive care units |
| Key secondary outcome measure(s) |
1. Standard care practices around enteral feeding and GRV measurement assessed using an e-survey in all UK PICUs and NICUs |
| Completion date | 01/09/2019 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 1200 |
| Key inclusion criteria | 1. Healthcare professionals working in UK PICU and NICUs who are involved in decision-making around feeding (nurses, doctors and dieticians) 2. Parents of children who have been in a UK PICU or NICU |
| Key exclusion criteria | Non PICU or NICU staff or parents who have not had this experience |
| Date of first enrolment | 01/05/2018 |
| Date of final enrolment | 01/07/2019 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Alder Hey Children's Hospital
Eaton Road
Liverpool
L12 2AP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | Data generated from the study will be kept within the Clinical Trials Unit repository and will not be publically shared except within the research team. The qualitative study data will be analysed at the University of Liverpool. All interviews and focus groups will get informed written consent. Surveys will collect unit level data only (survey 1) and expert opinion (survey 2) and consent will be implied by return of the survey. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2020 | 23/11/2020 | 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 |
Editorial Notes
23/11/2020: Publication reference added.
12/10/2018: The trial website was added.
20/02/2018: Internal review.
