GASTRIC Study
A Feasibility Study of No Routine Gastric Residual Volume
measurement in mechanically ventilated Infants and Children
Chief Investigator
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Institution
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Dates
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Funding Stream
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Grant Ref
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Amount
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Dr Lyvonne Tume
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University of the West of England, Bristol
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01/04/2018 - 30/09/2019
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NIHR Health Technology Assessment (HTA)
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16/94/02
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£343,123.82
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Summary
This study aims to identify the benefits of regularly measuring
the amount of fluid in a child or baby's stomach (GRV) 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 intensive
care units in the UK, but it is unclear if this practice is
helpful. One problem we know about is that it can delay the child
getting the full amount of feed they need. Although there is
research evidence from adults in intensive that not measuring it is
safe, and they got more calories, we do not know whether not
measuring GRV in babies and children could cause harm or be
beneficial. Before a full trial can be undertaken, preparatory work
is needed and this proposed study aims to do this. The research is
important because 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. If
measuring GRV is not beneficial, then there will be savings in time
and cost for staff and potential benefits from reaching nutritional
dietary intakes sooner. Ensuring that babies and children have
adequate feed is vital in intensive care, and not doing so slows
recovery. Adequate energy supply to the organs, especially the
brain and heart is needed in severe illness, and recovery requires
enough calories to help heal damaged tissues. We know that
inadequate nutrition is common in babies and children in intensive
care units and measuring GRV may be contributing to this. All
children's and baby's intensive care units in the UK measure GRV
routinely, unlike in other countries like France. Before changing
practice in the UK, it is necessary to undertake a study to
determine the benefits and safety of not measuring GRV.
How will it be done?
We want to carry out research to assess whether we can feasibly
do a trial across the UK. We will review the published literature
and explore parents' and healthcare professionals' (nurses, doctors
and dietitians) views around this practice (by surveys, interviews
and a face to face meeting). We will also explore whether they
would be prepared to participate in a future study and how they
think we should approach such a study. From parents, we also want
to know if this is important to them and whether they would be
happy for their child to take part. We will develop and agree
protocols for both measuring and not measuring GRV. We will use
existing national children's and neonatal intensive care databases
to see if a trial is feasible. In the UK, children (0-17 years) and
newborn babies are admitted to different types of intensive care
units, with different staff and so we will conduct this study in
parallel in both settings. Our research team (includes doctors,
nurses, dietitians, social scientists and researchers from both
PICU and NICU) is ideally placed to undertake this work. We will
utilise the expertise of French intensive care teams who have
already stopped measuring gastric residuals.
Impact (why is research important? / Expected Output of
Research)
There are nine intended outputs and deliverables from this
feasibility study:
- A clear indication of whether a trial of routine GRV versus no
GRV is feasible in 1) UK PICUs and 2) UK NICUs in terms of:
clinical equipoise, willingness to randomise and implement the
intervention, patient recruitment and parent willingness to
participate
- A clear indication of whether this intervention (and a future
trial) is acceptable to parents in both PICU and NICU
- Clearly defined and agreed control (with routine GRV
measurement) feeding guideline for 1) PICU and 2) NICU
- Clearly defined and agreed intervention (no routine GRV
measurement) feeding guideline for 1) PICU and 2) NICU (including a
nurse education pack)
- An agreed optimal trial design, including sample size
estimation with clear inclusion and exclusion criteria, outcome
measures and trial feasibility based on patient eligibility
data
- Parent information leaflet to explain the study and future
trial
- A clear indication of whether it is possible to combine PICU
and NICU settings into one trial
- An open access results paper for the PICU stream (Pediatric
Critical Care Medicine)
- An open access results paper from the NICU stream (Archives of
Diseases in Childhood, Fetal and Neonatal Edition) Through these
outputs, we will ensure that the feasibility impacts upon the PICU
and NICU community, patient and parent groups and a report to the
HTA will determine whether progression to a full trial is
feasible.
Patient and public involvement
We have consulted with parents from both neonatal intensive care
(through personal contacts and via the charity BLISS), and
paediatric intensive care (through the PICANET parents group and
also personal contacts). We have also consulted with an ex-PICU
patient (now 18 years). All parents agreed that this topic was
important to them and that our proposed feasibility study would
genuinely elicit parent's views. Our proposed study will use an
experienced PPI lead (Jenny Preston) to coordinate a parental study
group and ensure their ongoing involvement in all stages of this
study. This parent study group which will comprise a minimum of 2
NICU and 2 PICU parents and will meet 2 times a year to provide
detailed feedback into this feasibility study in terms of
identifying relevant questions to ask parents and families,
feedback on parental information required, their views on the
results and involvement in the Delphi and consensus phase of the
study. Because of the combination of two separate medical
specialities in this commissioned call, and the number of
co-applicants, we have decided to use this approach above rather
than enlist another 4 parent co-applicants onto the grant.
Links to further information
https://www.journalslibrary.nihr.ac.uk/programmes/hta/169402#/
http://www.grvstudy.com/
