A nurse-led standardized bedside gastric ultrasound monitoring protocol for abdominal distension management in critically ill patients receiving enteral nutrition: a pragmatic, exploratory randomized controlled trial

ObjectiveTo evaluate the feasibility and exploratory clinical effects of a standardized, nurse-led bedside gastric ultrasound-guided monitoring protocol for abdominal distension management in critically ill patients receiving enteral nutrition.MethodsIn this single-center, pragmatic, exploratory randomized controlled trial, critically ill adults receiving enteral nutrition in the intensive care unit of Henan Provincial People's Hospital were assigned 1:1 to ultrasound-guided gastric residual volume (GRV) monitoring or syringe-aspiration monitoring. The primary outcome was abdominal circumference on day 7. Secondary outcomes included intra-abdominal pressure (IAP), exploratory biomarkers, gastric retention, feeding intolerance, and implementation measures.ResultsOf 112 patients assessed, 100 were randomized and 91 completed the 7-day protocol, giving an overall retention rate of 91%. In the intervention group, the median number of ultrasound assessments was 14 per patient (IQR, 10–19), and protocol adherence was 82/89 (92.1%). Day-7 abdominal circumference was lower in the intervention group after baseline adjustment (adjusted mean difference, −2.35 cm; 95% CI, −3.28 to −1.43; P < 0.001). Baseline-adjusted IAP was also lower (−1.68 mmHg; 95% CI, −2.51 to −0.86; P < 0.001). Feeding intolerance did not differ significantly between groups (31.9% vs. 47.7%; RR, 0.67; 95% CI, 0.40–1.12; Fisher exact P = 0.139). Albumin was higher after baseline adjustment, whereas prealbumin did not differ significantly.ConclusionThe nurse-led protocol was feasible in this single-center population of non-intubated, relatively hemodynamically stable ICU patients and provided preliminary estimates for abdominal distension-related outcomes. The albumin result was exploratory and should not be taken as evidence of improved nutritional delivery. Secondary analyses were not adjusted for multiplicity and require cautious interpretation. The lack of prospective registration is a major limitation, and the findings do not apply to mechanically ventilated or hemodynamically unstable patients.Trial registrationThe randomized design, outcomes, and analysis plan were specified in the ethics-approved protocol before enrollment. However, the separate requirement for registration in a public trial registry was overlooked, and the study was not prospectively registered [Ethics Committee of Henan Provincial People's Hospital, approval No. 2023(Ethics)127].