Determining Optimal Outcome Measures in a Trial Investigating No Routine Gastric Residual Volume Measurement in Critically Ill Children

Abstract

Background Choosing trial outcome measures is important. When outcomes are not clinically relevant or important to parents/patients, trial evidence is less likely to be implemented into practice. This study aimed to determine optimal outcome measures for a trial of no routine gastric residual volume (GRV) measurement in critically ill children. Methods A mixed‐methods approach was used: a focused literature review, parent and clinician interviews, a modified 2‐round Delphi, and a stakeholder consensus meeting. Results The review generated 13 outcomes. Fourteen pediatric intensive care unit (PICU) parents proposed 3 additional outcomes; these 16 were then rated by 28 clinicians in Delphi round 1. Six further outcomes were proposed, and 22 outcomes were rated in the second round. No items were voted “consensus out.” The 18 “no‐consensus” items were voted in a face‐to‐face meeting by 30 participants. The final 12 outcome measures were time to reach energy targets, ventilator‐associated pneumonia, vomiting, time enteral feeds withheld per 24 hours, necrotizing enterocolitis, length of invasive ventilation, PICU length of stay, mortality, change in weight and markers of feed intolerance (parenteral nutrition administered), feed formula altered, and change to postpyloric feeds all secondary to feed intolerance. Conclusion We have identified 12 outcomes for a trial of no GRV measurement through a multistage process, seeking views of parents and clinicians.

Prospective evaluation of a novel enteral feeding guideline based on individual gastric emptying times: an improvement project in a pediatric intensive care unit

“…If a GRV is >50% of the last bolus feed, it is returned, and if this recurs 2 hours later, the individual's GET is redefined. The literature suggests abandoning GRVs to direct feeding and highlights a need for alternative bedside tools to measure gastric emptying 23,38–41 . We acknowledge that GRVs are inaccurate, as shown by a laboratory simulation 42 ; do not take account of gastric juices or swallowed secretions; do not predict delayed gastric emptying with continuous feeding 43 ; do not affect development of ventilator‐associated pneumonia 44,45 ; and are not recommended by ASPEN 1 to drive EN advancement.…”

Impact of Nutrition Support Team in Achieving Target Calories in Children Admitted in Pediatric Intensive Care Unit

“…A survey in UK PICUs showed that routine measurement of GRV was part of the standard practice, which shows that translation of evidence into practice take time and effort and we wanted to achieve low hanging fruit first (29). There have been some recent works to determine the patients related outcomes of trials studying effects of measuring or not measuring GRV (30,31).…”

Can they stomach it? Parent and practitioner acceptability of a trial comparing gastric residual volume measurement versus no gastric residual volume in UK NNU and PICUs: a feasibility study

“…In line with the Medical Research Council's framework for complex intervention development [23] conducting trial feasibility studies can help mitigate these challenges and establish whether the trial is acceptable to parents and practitioners, and practical to conduct [24,25]. As part of a pre-trial feasibility study [14,26], we explored parent and practitioner perspectives on the acceptability of conducting a clinical trial comparing no routine GRV measurement (the intervention) to routine GRV measurement in UK neonatal intensive care units (NNU) and paediatric intensive care unit (PICU) settings.…”