No routine measurement of gastric residual volume in paediatric critical care
| ISRCTN | ISRCTN79668198 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79668198 |
| IRAS number | 322370 |
| Secondary identifying numbers | CPMS 54988, IRAS 322370 |
- Submission date
- 07/02/2023
- Registration date
- 05/04/2023
- Last edited
- 20/05/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Digestive System
Plain English Summary
Background and study aims
Most children in intensive care cannot eat normally by mouth and require feeding into their stomach via a tube (a nasogastric (NG) tube or gastrostomy). It is important to provide enough calories to children through their feeds while they are critically ill, as this can help them to get off the ventilator faster, improves how quickly wounds heal and generally helps them to recover better from their illness. Ensuring children in intensive care have enough calories from feeds is a big challenge. We know from large worldwide studies that most children in intensive care get only around half of the calories they need. This is mainly due to their feeds being stopped. The most common reason is that the amount of fluid in the stomach is felt to be ‘large’. Across the UK, it is a common practice in all Paediatric Intensive Care Units (PICU) for nurses to check how much food is in the stomach. A syringe is attached to the end of the feeding tube and the child’s stomach contents are gently ‘sucked out’. This is to see how much fluid is in the child’s stomach and see how well the child is digesting their feed. This is called the gastric residual volume or GRV, often referred to as an ‘aspirate’. If a child has a ‘large’ GRV, often feeding is stopped. However, the amount of fluid in the child’s stomach is affected by many things, not just how much we feed them, but also how much gastric juice their stomach produces and some of the medicines we use slow down the stomach’s actions. The measurement of this (GRV) through the NG tube or gastrostomy is known to be quite inaccurate. Therefore, a decision may be taken to stop feeds, or not to increase feeds, when there is no need to. We do not know whether it is better to measure GRV routinely or not and this is why we are doing this study. This study aims to determine the clinical and cost-effectiveness of no routine GRV measurement to guide enteral feeding and to determine if it is non-inferior to standard at least 6 hourly GRV measurements in mechanically ventilated children admitted to PICU.
Who can participate?
Children who are mechanically ventilated and tube fed, who are aged at least 37 weeks corrected gestational age and less than 16 years
What does the study involve?
Half of the children in the study will be assigned to the routine GRV group where their stomach contents will be measured at least every 6 hours, the common practice in most paediatric intensive care units in the UK to control for feed intolerance or the stomach getting too full. The other half of the children will not have this done and instead will be monitored for feed intolerance/stomach fullness using clinical signs only.
What are the possible benefits and risks of participating?
While the research team cannot guarantee that taking part in this study will benefit the participants, they may receive more of their required calorie (energy) needs from their feeds, which is important for recovery and reducing the length of illness. Also, by being in this study there will be a more detailed observation of the child’s calorie and feed intake, along with other things such as the time they spend on the breathing machine. If a child is selected to have their GRV measured, they will be receiving standard UK care, so there will be no difference from ‘usual care’. If a child is chosen at random to ‘no GRV measurement’ the risk is that the child’s stomach might get full, and they might vomit and inhale this vomit into their lungs. However, this risk has never been proven. There is also a risk that when GRV is aspirated and returned into the child’s stomach, this may also cause vomiting. This will not take place in the no GRV group. Small studies have not found any additional risks in children who did not have their GRV measured regularly, and in some countries (France) GRV is not routinely measured.
Where is the study run from?
The study is coordinated by Intensive Care National Audit and Research Centre (ICNARC) CTU (UK)
When is the study starting and how long is it expected to run for?
September 2022 to June 2025
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Irene Chang (Trial Manager), irene.chang@icnarc.org
Contact information
Principal Investigator
Edge Hill University
Faculty of Health
Social Care & Medicine
St Helen’s Road
Ormskirk
L39 4QP
United Kingdom
 ORCID ID |
0000-0002-2547-8209 |
|---|---|
| Phone | +44 (0)7710412142 |
| Lyvonne.tume@edgehill.ac.uk |
Scientific
Trial Manager
Intensive Care National Audit & Research Centre (ICNARC)
Napier House
24 High Holborn
London
WC1V 6AZ
United Kingdom
| Phone | +44 (0)204 513 6249 |
|---|---|
| irene.chang@icnarc.org |
Public
-
-
-
United Kingdom
| gastric@icnarc.org |
Study information
| Study design | Randomized interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised controlled trial of no routine gastric residual monitoring to guide enteral feeding in paediatric intensive care units. |
| Study acronym | GASTRIC-PICU |
| Study hypothesis | GASTRIC-PICU study aims to identify if no routine measurement of gastric residual volume (GRV) to guide enteral feeding in paediatric intensive care units is non-inferior to the regular measurement of GRV at least 6 hourly in terms of clinical and health economics outcomes. |
| Ethics approval(s) |
Approved 15/05/2023, London-Bloomsbury REC (3rd Floor Barlow House, 4 Minshull Street, Manchester, M1 3DZ, United Kingdom; +44 (0)207104828; bloomsbury.rec@hra.nhs.uk), ref: 23/LO/0284 |
| Condition | Oral and Gastrointestinal |
| Intervention | GASTRIC-PICU is a multi-centre, randomised, noninferiority, open-label trial with an internal pilot phase (with clear stop/go progression criteria to full trial) and health economic evaluation and patient follow-up at 6 months. A randomised controlled trial (RCT) design was chosen as this is the gold standard design for clinical trials. The GASTRIC-PICU trial aims to determine the clinical and cost-effectiveness of no routine gastric residual volume (GRV) measurement to guide enteral feeding and to determine if it is non-inferior to standard at least 6 hourly gastric residual volume measurements in mechanically ventilated children admitted to PICU. The primary clinical objective is to determine whether no routine GRV measurement is non-inferior to at least 6 hourly GRV measurements to guide enteral feeding in critically ill ventilated children in PICU in terms of a composite outcome of survival and days free from mechanical ventilation (non-inferiority) and superior in terms of achievement of their estimated energy requirement (superiority). The primary health-economic objective is to conduct a full economic evaluation to assess the relative cost-effectiveness of these two practices. Secondary objectives are to compare the non-routine measurement with regular up to 6 hourly measurements in terms of other important patient and family-centred outcomes and costs. We will include 4,700 patients from at least 19 paediatric critical care units. The study will use a deferred consent model due to the emergency nature of the patient population. Eligible patients will be randomised by the PICU and their parents or legal guardians will be approached for consent to continue in the study at the earliest appropriate opportunity. Eligible patients will be randomised to one of two study arms: 1. Intervention arm - no routine GRV measurement to guide enteral feeding. Patients in this study arm will be monitored for signs of feed intolerance using clinical signs only: vomiting and other gastrointestinal or systemic signs but not by using GRV. 2. Control arm - routine (at least 6 hourly) GRV measurements to guide enteral feeding. Patients in this study arm will be monitored for feed intolerance using the GRV measurements as well as vomiting, and other gastrointestinal or systemic signs. All other clinical care for patients in both treatment groups will be determined by the clinical team responsible for the patient's care. Data will be collected daily whilst in PICU to describe the intensity and duration of treatment, alongside routine data collection. Patients will be followed up after 6 months to ascertain their quality of life. One interim analysis will be undertaken to check for evidence of significant harm or benefit. INTERNAL PILOT The internal pilot phase will last for ten months and will assess key progression criteria using a traffic light system. Key progression criteria will include site opening, patient recruitment, and treatment adherence. The same processes as the main RCT will be used throughout the internal pilot phase, with all patients recruited in the ten-month period included in the final analysis. INDEPENDENT COMMITTEES Both a Trial Steering Committee and an independent Data Monitoring & Ethics Committee (DMEC) will be convened and will meet regularly during the trial. The DMEC will monitor recruitment and retention, protocol adherence (including adherence to treatment protocols) and patient safety (including serious adverse events) and will review the interim analysis. TIMELINE Funding has been obtained from the NIHR for a 42-month period: Months 1-6: Study set-up: all approvals & preparation for the start of the trial (site sign-up and local approvals, production of materials for participating sites, conducting site initiation meetings) Months 7-40: Recruitment/follow-up period Months 7-16: Internal pilot stage Month 17: First annual REC report Month 13: First follow-up questionnaires sent Month 18: Second DMEC and TSC meetings to review internal pilot analysis Internal pilot report submitted to NIHR HTA Month 32: Close to recruitment Month 38: Final follow-up questionnaires Months 39-42: Analysis and dissemination Month 40: Database lock for primary analysis (clinical and economic evaluation) Commence primary analysis and write up Month 40: Lock database for longer-term outcomes Month 42: Submit primary outcome paper Collaborators’ meeting Final DMEC and TSC meetings Month 42: Submit longer-term outcomes paper and draft final report to NIHR |
| Intervention type | Other |
| Primary outcome measure | 1. Composite outcome of survival and days free from mechanical ventilation measured using patient medical records at 30 days (non-inferiority) 2. Percentage of the child’s estimated energy requirements achieved by 72 hours after randomisation (superiority) measured using patient medical records and Schofield equation at 72 hours post-randomisation 3. Incremental net monetary benefits at six months (cost-effectiveness analysis) measured using health care services questionnaire and patient medical notes at 6 months post-randomisation |
| Secondary outcome measures | 1. Time to the achievement of target energy requirement measured using patient medical records and Schofield equation at 72 hours post-randomisation 2. Time to the achievement of target protein requirement measured using patient medical records at 72 hours post-randomisation 3. Diagnosis of ventilator-associated pneumonia (VAP) measured using patient medical records at 30 days post-randomisation 4. Diagnosis of necrotising enterocolitis (NEC) in infants – using patient medical records at 30 days post-randomisation 5. Duration of time with no enteral feed in the first 7 days after randomisation measured using patient medical records at 7 days 6. Incidence of vomiting leading to feed stoppage in the first 7 days after randomisation measured using patient medical records at 7 days 7. Documented healthcare-acquired infections measured using patient medical records at 30 days post-randomisation 8. Length of PICU stay and hospital stay measured using patient medical records at 30 days and 6 months post-randomisation 9. Mortality at 30 days and 6 months measured using patient medical records at 30 days and 6 months post-randomisation 10. Resource use and costs measured using Health Care services questionnaires at 6 months 11. Health-related quality of life measured using the pediatric quality of life inventory (PedsQL) and the validity of the child health utility instrument (CHU9D) questionnaire data at 6 months post-randomisation 12. Quality-adjusted life years (QALYs) measured using PedsQL and CHU-9D questionnaire data at 6 months post-randomisation 13. Feeding measured using the feeding component of the Functional Status Score at 6 months post-randomisation |
| Overall study start date | 01/09/2022 |
| Overall study end date | 30/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 37 Weeks |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 4700; UK Sample Size: 4700 |
| Participant inclusion criteria | Current participant inclusion criteria as of 20/05/2024: 1. Aged > = 37 weeks corrected gestational age and < 16 years at the time of randomisation 2. Enrolled within 24 hours of first meeting all the following criteria: 2.1. Receiving invasive mechanical ventilation (with extubation not planned in the next 48 hours) 2.2. Intention to start feeding or started feeding via the gastric route (including gastrostomy) Previous participant inclusion criteria: 1. Aged > = 37 weeks corrected gestational age and < 16 years at the time of randomisation 2. Receiving invasive mechanical ventilation (with extubation not planned in the next 48 hours) 3. Intention to start feeding via the gastric route (including gastrostomy) |
| Participant exclusion criteria | 1. Post-pyloric feeding or jejunostomy 2. End-of-life care plan in place with limitation of resuscitation 3. Children on long-term mechanical ventilation 4. Current or recent gut pathology or surgery (e.g., necrotising enterocolitis (NEC), active GI bleeding, or any intestinal surgery) 5. Known to have been enrolled in the GASTRIC-PICU trial in the last 6 months |
| Recruitment start date | 29/06/2023 |
| Recruitment end date | 01/08/2025 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Marlborough Street
Bristol
BS1 3NU
United Kingdom
Westminster Bridge Road
London
SE1 7EH
United Kingdom
London
WC1N 3JH
United Kingdom
London
SE5 9RS
United Kingdom
Leicester
LE1 5WW
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Headington
Oxford
OX3 9DU
United Kingdom
Southampton
SO16 6YD
United Kingdom
Tooting
London
SW17 0QT
United Kingdom
St Marys Hospital
South Wharf Road
London
W2 1BL
United Kingdom
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
2-4 Waterloo Place
Edinburgh
EH1 3EG
United Kingdom
Nottingham
NG7 2UH
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
A Floor - Belfast City Hospital
Lisburn Road
Belfast
BT9 7AB
United Kingdom
Birmingham
B4 6NH
United Kingdom
Sheffield
S10 2TH
United Kingdom
Stafford
ST16 2LP
United Kingdom
West Derby
Liverpool
L12 2AP
United Kingdom
Belfast
BT12 6BA
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Sponsor information
Hospital/treatment centre
C/o: Paul Mouncey
Napier House
24 High Holborn
London
WC1V 6AZ
England
United Kingdom
| Phone | +44 (0)2072699277 |
|---|---|
| paul.mouncey@icnarc.org | |
| Website | http://www.icnarc.org/ |
"ROR" |
https://ror.org/057b2ek35 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of the GASTRIC-PICU trial will be disseminated actively and extensively. This will cover both progress during the trial period and the results at the end of the study. The outputs for the GASTRIC-PICU trial will include, but will not be limited to, the following areas: 1. Meeting and conference presentations (national and international) of study progress and results 2. Publication of study results, primary results and longer-term outcomes, including economic evaluation; and 3. Incorporation into clinical guidelines. These separate outputs will be targeted at relevant stakeholders in formats suitable for the target audience. This will ensure that the potential benefit of GASTRIC-PICU is maximised. Following publication, the results will also be disseminated using social media for both professionals and a lay summary that will be co-designed with the Patient Advisory Group (PAG). Dissemination will also be via UK, European and International PICU networks at meetings and special dissemination events. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from GASTRIC@icnarc.org |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 20/09/2023 | No | No |
Editorial Notes
20/05/2024: The following changes were made:
1. A study contact was updated.
2. Participant inclusion criteria were changed.
20/09/2023: A link to the HRA research summary was added.
11/07/2023: Ethics approval details added. The recruitment start date was changed from 01/05/2023 to 29/06/2023.
09/05/2023: Trial website added.
21/04/2023: Internal review.
05/04/2023: Internal review.
07/02/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
