Title: A Feasibility Study of No Routine Gastric Residual Volume measurement in mechanically ventilated Infants and Children: the GASTRIC Study
Funder: Department of Health and Social Care

Abstract: DESIGN: A mixed method study involving 5 linked work packages, running in two parallel arms, one in NICU and one in PICU (See Study Flowchart) over an 18-month time frame. SETTING: 190 NICUs and 27 PICUs across the UK POPULATION: PICU and NICU clinicians (nurses, doctors, dietitians), trialists and PICU and NICU parents. HEALTH TECHNOLOGY BEING ASSESSED: Gastric residual volume measurement is defined in this study as the practice of routinely aspirating the whole stomach contents into a syringe to ascertain both the volume of fluid in the stomach and the appearance of this fluid (routine practice in the UK). This practice will be explored and a control arm (a consistent approach to this practice) agreed as part of this study. The intervention (NOT measuring GRV) will be defined as delivering enteral feeding without the use of routine GRV assessment, instead using clinical parameters (to be defined and agreed) to gauge feeding tolerance. Concerns around this practice will also be explored and a no GRV intervention agreed as part of this study. INTENDED STUDY OUTPUTS: 1) A clear indication of whether a trial of routine GRV versus no GRV is feasible in UK PICUs and NICUs in terms of: clinical equipoise, willingness to randomise and implement the intervention, patient recruitment and parent willingness to participate 2) To determine the acceptability of a trial of no GRV measurement to parents 3) Clearly defined control and intervention arms of a future trial 4) An agreed optimal trial design, including clear inclusion and exclusion criteria, outcome measures and trial feasibility 5) A clear indication of whether it is possible to combine PICU and NICU settings into one trial TIMETABLE: Study duration 18 months. Proposed start date 01/04/2018. see Study Flowchart and gantt chart for study timetable. TEAM EXPERTISE: Our multidisciplinary research team (including doctors, nurses, dietitians, social scientists and trialists) is has the breadth and depth of knowledge and research expertise to successfully deliver this project. Our team is a collaboration between paediatric and neonatal specialists and will utilize the expertise of French intensive care teams who have already stopped measuring gastric residuals. The neonatal team includes members of a successful HTA funded trial (SIFT) that showed benefits from speeding up the time to full feeding very premature infants (JD) and has expertise (CG) linked to the national neonatal research database which will inform the work. In the paediatric team LT has conducted a national survey of practice around enteral feeding in PICUs in 2012, showing GRV is a major factor affecting decisions to withhold feeds. LT and FV have conducted a pilot comparison observational study of GRV versus no GRV measurement in 2 PICUs. This found that not measuring GRV caused no harm, and the child’s nutritional requirements were more consistently achieved when GRV was not measured (1). KW is an experienced qualitative researcher who will lead the qualitative component of the study. RP is an epidemiologist linked to PICANet. We also have the expertise of PICU and NICU dietitians (LL,RM), PICU and NICU clinical nurses (LT and IA) and PICU and NICU intensive care doctors (NP, JD, CG), the French intensive care clinicians (FV, AB) along with the CTU team (HH, MB), social scientists (KW) and the PPI lead (JP).

Lay abstract: 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.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: GENERIC HEALTH RELEVANCE