An Implementation Study on Preoperative Fasting Time Management for Pediatric Surgical Patients

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: Control group:Children who receive conventional preoperative fasting management;intervention group:This study employed a stepped‐wedge cluster randomized trial design. The intervention was the "6‐4‐3‐2" preoperative fasting management protocol, implemented in a stepwise manner: Stepped implementation framework: All target wards began the study in the routine care phase. During the research process, wards transitioned from the routine care phase to the "6‐4‐3‐2" protocol implementation phase sequentially at predetermined, fixed time points according to a pre‐randomized order. Core implementation measures (initiated upon each ward's transition): Standardized training: All healthcare staff in the transitioning ward received training and assessment on the "6‐4‐3‐2" protocol. Process and tool integration: The ward was equipped with illustrated parent instruction sheets, and fasting verification prompts were embedded in their bedside call/electronic medical record systems. Continuous quality improvement: Regular fasting compliance audits and multidisciplinary feedback mechanisms were established for the ward. In summary, the intervention was "a standardized fasting management protocol," implemented by "initiating and executing it sequentially (stepwise) in various wards (clusters) according to a randomized order."; CONDITION: N/A PRIMARY OUTCOME: Compliance rate of preoperative clear liquid fasting in pediatric patients; SECONDARY OUTCOME: Actual fasting duration for solid fatty foods (meat) before surgery;Non‐fat solid foods (starchy, protein‐based) actual fasting duration before surgery;Formula milk (powdered milk, cow's milk) actual fasting time before surgery;Actual fasting time before breastfeeding surgery;Actual fasting time before clear liquid surgery. (Clear liquids: water, tea, juice without pulp, non‐carbonated beverages);Incidence of hypoglycemia (intraoperative blood glucose <3.9 mmol/L);Incidence of hypotension;Perioperative intravenous fluid administration rate;Incidence of postoperative nausea and vomiting (PONV);Parent satisfaction;Child coverage rate;Core training completion rate for target medical staff;Knowledge level score of medical staff;Thirst Score;Hunger Score;Crying rate; INCLUSION CRITERIA: I. Inclusion Criteria for Program Implementers (Medical Staff) (Must Meet All): 1. Possess a valid physician or nurse practitioner qualification certificate. 2. Have worked continuously in the target study ward for =1 year. 3. Their daily work directly involves the management, education, or prescription of preoperative fasting for children (e.g., ward nurses, anesthesiologists, surgeons). II. Inclusion Criteria for Target Population (Children and Their Guardians) (Must Meet All): 1. Children: Aged =18 years; scheduled for elective surgery with plans to return to a general ward postoperatively; require preoperative oral fasting. 2. Guardians: Must be the child’s primary legal guardian, capable of effective communication, and willing to voluntarily sign the informed consent form.
Epistemonikos ID: 39739be723095668965604480b7da682feeaa070
First added on: Jan 24, 2026