ChiCTR2600116466 版本V1.2 版本创建时间2026/02/03 09:55:56 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2600116466 

最近更新日期：

Date of Last Refreshed on：

 2026-01-12 18:06:41 

注册时间：

Date of Registration：

 2026-01-09 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

儿科手术患者术前禁食时间管理的实施性研究

Public title：

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

注册题目简写：

English Acronym：

研究课题的正式科学名称：

儿科手术患者术前禁食时间管理的证据转化及应用研究

Scientific title：

Evidence Translation and Application in Preoperative Fasting Time Management for Pediatric Surgical Patients: A Study

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

邹芳琳 

研究负责人：

刘婷 

Applicant：

Zou Fanglin 

Study leader：

Liu Ting 

申请注册联系人电话：

Applicant telephone：

 +86 188 6611 0378

研究负责人电话：

Study leader's
telephone：

+86 188 5310 8811

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 2024211269@mail.sdu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 123110435@qq.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

山东省济南市槐荫区经十路23976号

研究负责人通讯地址：

山东省济南市槐荫区经十路23976号

Applicant address：

No. 23976, Jingshi Road, Huaiyin District, Jinan City, Shandong Province

Study leader's address：

No. 23976, Jingshi Road, Huaiyin District, Jinan City, Shandong Province

申请注册联系人邮政编码：

Applicant postcode：

 250000

研究负责人邮政编码：

Study leader's postcode：

 250000

申请人所在单位：

山东大学附属儿童医院(济南市儿童医院)

Applicant's institution：

Children's Hospital Affiliated to Shandong University (Jinan Children's Hospital)

研究负责人所在单位：

山东大学附属儿童医院(济南市儿童医院)

Affiliation of the Leader：

Children's Hospital Affiliated to Shandong University (Jinan Children's Hospital)

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 SDFE- IRB/P-2025014

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

济南市儿童医院伦理委员会

Name of the ethic committee：

Ethics Committee of Jinan Children's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-12-02 00:00:00

伦理委员会联系人：

郭磊

Contact Name of the ethic committee：

Guo Lei

伦理委员会联系地址：

山东省济南市槐荫区经十路23976号

Contact Address of the ethic committee：

No. 23976, Jingshi Road, Huaiyin District, Jinan City, Shandong Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 531 5961 6082

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 etjrxgl@hotmail.com

研究实施负责（组长）单位：

山东大学附属儿童医院(济南市儿童医院)

Primary sponsor：

Children's Hospital Affiliated to Shandong University (Jinan Children's Hospital)

研究实施负责（组长）单位地址：

山东省济南市槐荫区经十路23976号

Primary sponsor's address：

No. 23976, Jingshi Road, Huaiyin District, Jinan City, Shandong Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

山东省

市(区县)：

济南市

Country：

China

Province：

Shandong

City：

Jinan

单位(医院)：

山东大学附属儿童医院(济南市儿童医院)

具体地址：

槐荫区经十路23976号

Institution
hospital：

Children's Hospital Affiliated to Shandong University (Jinan Children's Hospital)

Address：

No. 23976, Jingshi Road, Huaiyin District

经费或物资来源：

研究者自筹经费

Source(s) of funding：

Researchers self-funded

研究疾病：

不涉及  

Target disease：

N/A

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

整群随机分组 

Study design：

Cluster randomization 

研究目的：

(一)总目标 本研究旨在通过设计并实施一套基于循证证据的多组分策略,评估其对“6-4-3-2”儿童术前禁食禁饮管理方案在我院外科病区中落实的效果,以提升患儿清饮料禁食管理的规范性,改善围术期舒适度与安全结局,并为该方案的可持续推广提供科学依据。 (二)具体目标 基于RE-AIM实施科学框架,本研究设定以下具体目标: (覆盖范围,Reach)? 评估该实施策略在目标患儿人群中的覆盖率,以及目标医护人员的培训完成率。 (有效性,Effectiveness)? 评估实施策略对以下指标的影响: a. 主要结局:患儿术前清饮料禁食管理依从率。 b. 次要结局:各类食物实际禁食时长、患儿低血糖等并发症发生率、患儿主观舒适度(口渴/饥饿评分、哭闹率)、家长满意度、医护人员知识水平与行为依从性。 (采纳情况,Adoption)? 评估目标科室(病区)对“6-4-3-2”方案的采纳率(即参与实施的病区比例)。 (实施情况,Implementation)? 评价各项核心实施策略(如培训、系统改造、审计反馈)的完成度与保真度,并初步分析实施成本。 (维持情况,Maintenance)? 前瞻性评估方案在个体(医护人员)与组织(科室)层面的持续应用潜力。  

Objectives of Study：

(I) Overall Objective This study aims to design and implement a multi-component strategy based on evidence to evaluate its effectiveness in promoting the adoption of the "6-4-3-2" preoperative fasting and drinking management protocol for children in the surgical wards of our hospital. The goal is to enhance the standardization of clear fluid fasting management, improve perioperative comfort and safety outcomes, and provide a scientific basis for the sustainable promotion of this protocol. (II) Specific Objectives Based on the RE-AIM implementation science framework, this study sets the following specific objectives: (Reach) Evaluate the coverage of this implementation strategy among the target pediatric population and the completion rate of training for the targeted healthcare providers. (Effectiveness) Assess the impact of the implementation strategy on the following indicators: a. Primary outcome: Compliance rate of preoperative clear fluid fasting management in children. b. Secondary outcomes: Actual fasting duration for various foods, incidence of complications such as hypoglycemia, subjective comfort of children (thirst/hunger scores, crying rate), parental satisfaction, and healthcare providers' knowledge level and behavioral compliance. (Adoption) Evaluate the adoption rate of the "6-4-3-2" protocol among target departments (wards), i.e., the proportion of wards participating in the implementation. (Implementation) Assess the completion and fidelity of core implementation strategies (e.g., training, system modifications, audit and feedback) and conduct a preliminary analysis of implementation costs. (Maintenance) Prospectively evaluate the potential for sustained application of the protocol at both the individual (healthcare providers) and organizational (department) levels.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

一、方案执行者（医护人员）纳入标准（须同时满足）： 1.具有有效的医师或护士执业资格证书。 2.在目标研究病区连续工作 ≥ 1年。 3.其日常工作内容直接涉及患儿术前禁食的管理、宣教或医嘱开具（如病房护士、麻醉医生、外科医生）。 二、方案目标人群（患儿及其监护人）纳入标准（须同时满足）： 1.患儿：年龄 ≤ 18周岁；拟行择期手术且计划术后返回普通病房；术前需经口禁食禁饮。 2.监护人：为患儿的主要法定监护人，能进行有效沟通，并自愿签署知情同意书。

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.

排除标准：

一、方案执行者（医护人员）排除标准： 1.研究期间处于长期休假（如产假、病假）或外出进修状态，无法参与方案培训与执行的医护人员。 2.拒绝参与本研究的医护人员。 二、方案目标人群（患儿及其监护人）排除标准（满足任一则排除）： 1.患儿相关：行急诊手术、日间手术或门诊手术；行器官移植手术；伴有严重肝、肾功能不全或糖尿病酮症酸中毒等影响代谢的严重基础疾病。 2.监护人相关：监护人存在沟通障碍，无法理解研究内容。

Exclusion criteria：

I. Exclusion Criteria for Program Implementers (Medical Staff): 1. Medical staff who are on long-term leave (e.g., maternity leave, sick leave) or away for further training during the study period and thus unable to participate in program training and implementation. 2. Medical staff who refuse to participate in the study. II. Exclusion Criteria for Target Population (Children and Their Guardians) (Excluded if Any Criteria Are Met): 1. Child-related: Undergoing emergency surgery, day surgery, or outpatient surgery; undergoing organ transplant surgery; suffering from severe underlying metabolic disorders such as severe liver or kidney dysfunction or diabetic ketoacidosis. 2. Guardian-related: Guardians with communication barriers who cannot understand the study content.

研究实施时间：

Study execute time：

从 From 2026-01-12 00:00:00至 To 2027-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-01-12 00:00:00 至 To 2027-12-31 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 1050

Group：

Control group

Sample size：

干预措施：

接受常规术前禁食管理的患儿

干预措施代码：

Intervention：

Children who receive conventional preoperative fasting management

Intervention code：

组别：

干预组

样本量：

 1050

Group：

intervention group

Sample size：

干预措施：

本研究采用阶梯式整群随机试验设计。干预措施为“6-4-3-2”术前禁食管理方案，并按阶梯方式实施： 阶梯实施框架：所有目标病区在研究开始时均处于常规护理阶段。在研究过程中，病区按照预先随机确定的顺序，在不同的、固定的时间点，依次从常规护理阶段转入“6-4-3-2”方案实施阶段。 核心实施措施（在每个病区转入时启动）： 标准化培训：对转入病区的全体医护人员进行“6-4-3-2”方案培训与考核。 流程与工具嵌入：为该病区配备图文版家长指导单，并在其床头呼叫/电子病历系统中嵌入禁食核查提示。 持续质量改进：建立针对该病区的定期禁食依从性审计与多学科反馈机制。 简而言之，干预措施是“一套标准化的禁食管理方案”，其实施方式是“按随机顺序、分阶段地（阶梯式）在各个病区（整群）中启动和执行”。

干预措施代码：

Intervention：

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."

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山东省 

市(区县)：

 济南市 

Country：

China

Province：

Shandong

City：

Jinan

单位(医院)：

 山东大学附属儿童医院(济南市儿童医院) 

单位级别：

 三甲 

Institution
hospital：

Children's Hospital Affiliated to Shandong University (Jinan Children's Hospital)

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

患儿术前清饮料禁食依从率

指标类型：

主要指标

Outcome：

Compliance rate of preoperative clear liquid fasting in pediatric patients

Type：

Primary indicator

测量时间点：

手术当日术前

测量方法：

数据收集：通过《择期手术儿童术前禁饮食情况调查问卷》，记录患儿实际末次清饮料摄入时间。 时长定义与计算： 实际禁食时长：指“实际末次清饮料摄入时间”至 “实际麻醉开始时间” 的间隔。此为本研究记录和报告的客观时长。 计划性禁食偏差：为评估干预措施对计划执行的效果，本研究定义一个关键指标“计划性禁食偏差”，即“实际末次清饮料摄入时间”至 “医嘱拟定手术时间” 的间隔。 依从性判定：本研究主要结局的判定基于 “计划性禁食偏差”。若此偏差在 2.00-2.25小时（含） 范围内，则判为“依从”；否则判为“不依从”。 计算公式：患儿术前清饮料禁食依从率 = (被判定为“依从”的患儿数 / 术前实际摄入了清饮料的患儿总数) × 100%。

Measure time point of outcome：

Preoperative on the day of surgery

Measure method：

Data Collection: The actual last intake time of clear liquids for pediatric patients was recorded using the "Questionnaire on Preoperative Fasting Status for Elective Surgery in Children." Duration Definition and Calculation: - Actual Fasting Duration: Refers to the interval between the "actual last intake time of clear liquids" and the "actual anesthesia start time." This is the objective duration recorded and reported in this study. - Planned Fasting Deviation: To evaluate the effective

指标中文名：

脂肪类固体食物（肉类）术前实际禁食时长

指标类型：

次要指标

Outcome：

Actual fasting duration for solid fatty foods (meat) before surgery

Type：

Secondary indicator

测量时间点：

手术当日术前

测量方法：

通过《择期手术儿童术前禁饮食情况调查问卷》，由家长报告患儿最后一次进食此类食物的具体时间。实际禁食时长为报告的末次进食时间点至手术麻醉开始时间点的间隔。

Measure time point of outcome：

Preoperative on the day of surgery

Measure method：

Through the "Questionnaire on Preoperative Fasting Status in Children Undergoing Elective Surgery," parents report the specific time when their child last consumed such food. The actual fasting duration is the interval between the reported last eating time and the start of anesthesia for surgery.

指标中文名：

非脂肪类固体食物（淀粉类、蛋白类）术前实际禁食时长

指标类型：

次要指标

Outcome：

Non-fat solid foods (starchy, protein-based) actual fasting duration before surgery

Type：

Secondary indicator

测量时间点：

手术当日术前

测量方法：

通过《择期手术儿童术前禁饮食情况调查问卷》，由家长报告患儿最后一次进食此类食物的具体时间。实际禁食时长为报告的末次进食时间点至手术麻醉开始时间点的间隔。

Measure time point of outcome：

Preoperative on the day of surgery

Measure method：

Through the "Questionnaire on Preoperative Fasting in Children Undergoing Elective Surgery," parents report the specific time their child last consumed such food. The actual fasting duration is the interval between the reported last eating time and the start of anesthesia for surgery.

指标中文名：

配方奶（奶粉、牛奶）术前实际禁食时间

指标类型：

次要指标

Outcome：

Formula milk (powdered milk, cow's milk) actual fasting time before surgery

Type：

Secondary indicator

测量时间点：

手术当日术前

测量方法：

通过《择期手术儿童术前禁饮食情况调查问卷》，由家长报告患儿最后一次进食此类食物的具体时间。实际禁食时长为报告的末次进食时间点至手术麻醉开始时间点的间隔。

Measure time point of outcome：

Preoperative on the day of surgery

Measure method：

Through the "Questionnaire on Preoperative Fasting in Children Undergoing Elective Surgery," parents report the specific time when their child last consumed such food. The actual fasting duration is the interval between the reported last eating time and the start of anesthesia for surgery.

指标中文名：

母乳术前实际禁食时间

指标类型：

次要指标

Outcome：

Actual fasting time before breastfeeding surgery

Type：

Secondary indicator

测量时间点：

手术当日术前

测量方法：

通过《择期手术儿童术前禁饮食情况调查问卷》，由家长报告患儿最后一次进食此类食物的具体时间。实际禁食时长为报告的末次进食时间点至手术麻醉开始时间点的间隔。

Measure time point of outcome：

Preoperative on the day of surgery

Measure method：

Through the "Questionnaire on Preoperative Fasting Status in Children Undergoing Elective Surgery," parents reported the specific time when the child last consumed such food. The actual fasting duration was the interval between the reported last eating time and the start of anesthesia for the surgery.

指标中文名：

清液术前实际禁食时间。（清液：水、茶、无果粒的果汁、非碳酸类饮料）

指标类型：

次要指标

Outcome：

Actual fasting time before clear liquid surgery. (Clear liquids: water, tea, juice without pulp, non-carbonated beverages)

Type：

Secondary indicator

测量时间点：

手术当日术前

测量方法：

通过《择期手术儿童术前禁饮食情况调查问卷》，由家长报告患儿最后一次进食此类食物的具体时间。实际禁食时长为报告的末次进食时间点至手术麻醉开始时间点的间隔。

Measure time point of outcome：

Preoperative on the day of surgery

Measure method：

Through the "Questionnaire on Preoperative Fasting Status in Children Undergoing Elective Surgery," parents report the specific time when the child last consumed such food. The actual fasting duration is the interval from the reported last eating time to the start of anesthesia for surgery.

指标中文名：

低血糖发生率（术中血糖<3.9 mmol/L）

指标类型：

次要指标

Outcome：

Incidence of hypoglycemia (intraoperative blood glucose <3.9 mmol/L)

Type：

Secondary indicator

测量时间点：

术中

测量方法：

在征得监护人知情同意后，研究者使用术中切口处产生的、本应作为医疗废弃物丢弃的血液，通过快速血糖仪（微量血糖试纸）监测血糖值，并记录血糖<3.9 mmol/L的发生情况。此操作不会对患儿造成额外创伤或风险，检测结果仅用于本研究分析。

Measure time point of outcome：

During the operation

Measure method：

After obtaining informed consent from the guardians, the researchers used blood from the surgical incision site, which would otherwise be discarded as medical waste, to monitor blood glucose levels with a rapid glucose meter (micro blood glucose test strips) and recorded instances of blood glucose <3.9 mmol/L. This procedure does not cause additional trauma or risk to the child, and the test results are used solely for the analysis of this study.

指标中文名：

术中误吸/返流发生率

指标类型：

副作用指标

Outcome：

Incidence of intraoperative aspiration/regurgitation

Type：

Adverse events

测量时间点：

术后

测量方法：

由麻醉医生和恢复室护士，依据以下客观标准进行诊断和记录： 误吸：在麻醉诱导、维持或苏醒期间，观察到胃内容物（食物、胃液）被吸入声门以下呼吸道，并经喉镜或支气管镜确认，或术后胸片出现新发的吸入性肺炎征象。 反流：在围手术期（从麻醉开始至术后2小时），观察到胃内容物反流至咽部或口腔，无论是否伴有呛咳或血氧下降。术中误吸/返流发生率=术中麻醉时发生误吸/返流的患儿例数/患儿总例数

Measure time point of outcome：

Postoperative

Measure method：

Diagnosis and documentation by anesthesiologists and recovery room nurses based on the following objective criteria: **Aspiration**: Observation of gastric contents (food, gastric fluid) entering the airway below the glottis during anesthesia induction, maintenance, or emergence, confirmed by laryngoscopy or bronchoscopy, or the presence of new signs of aspiration pneumonia on postoperative chest X-ray. **Regurgitation**: Observation of gastric contents flowing back into the pharynx or oral

指标中文名：

低血压发生率

指标类型：

次要指标

Outcome：

Incidence of hypotension

Type：

Secondary indicator

测量时间点：

麻醉诱导前、术中、术后24小时内

测量方法：

收缩压低于同年龄、性别、身高儿童第5百分位数

Measure time point of outcome：

Before anesthesia induction, during surgery, and within 24 hours postoperatively

Measure method：

Systolic blood pressure below the 5th percentile for children of the same age, sex, and height.

指标中文名：

围术期静脉补液率

指标类型：

次要指标

Outcome：

Perioperative intravenous fluid administration rate

Type：

Secondary indicator

测量时间点：

手术当日术后

测量方法：

定义：本指标特指因非医疗必需原因（见下）在围术期（从病房至手术结束）接受的静脉输液。 纳入与排除： 排除（不计入）：为建立麻醉通路、输注麻醉/治疗药物（如抗生素）所必需的最低液体量。 纳入（计入）：医嘱或护理记录中明确为“补充容量”、“预防/纠正脱水”、“因患儿长时间禁食后口渴/哭闹”等非强制性原因而开具的静脉补液。 数据来源：通过回顾麻醉记录单、护理记录单及医嘱系统，交叉核对并记录所有围术期静脉液体的种类、输注量及开具原因。 计算公式：围术期静脉补液率 (%) = (符合上述“纳入”标准的患儿例数 / 同期纳入研究的患儿总例数) × 100%。 补充说明：为深入分析，我们将同时记录补液量（毫升）及补液相关直接物料成本，以更敏感地评估资源消耗变化。

Measure time point of outcome：

Postoperative on the day of surgery

Measure method：

This indicator specifically refers to intravenous fluids administered during the perioperative period (from the ward to the end of surgery) for non-medically necessary reasons (see below). Inclusion and Exclusion: Excluded (not counted): The minimum fluid volume required to establish anesthesia access or administer anesthesia/therapeutic medications (e.g., antibiotics). Included (counted): Intravenous fluids explicitly prescribed in medical orders or nursing records for non-ma

指标中文名：

术后恶心呕吐（PONV）发生率

指标类型：

次要指标

Outcome：

Incidence of postoperative nausea and vomiting (PONV)

Type：

Secondary indicator

测量时间点：

术后24小时内

测量方法：

护士在术后24小时内，通过结构化观察或《择期手术儿童术前禁饮食情况调查问卷》记录患儿是否发生恶心（主诉或表现为烦躁、捂嘴、吞咽动作等）和/或呕吐（观察到胃内容物经口吐出）。计算PONV发生率 = （术后24小时内发生恶心或呕吐的患儿例数 / 同期患儿总例数）× 100%。

Measure time point of outcome：

Within 24 hours after surgery

Measure method：

Within 24 hours post-operation, nurses record whether the child experiences nausea (complaints or manifestations such as restlessness, covering the mouth, swallowing movements, etc.) and/or vomiting (observed oral expulsion of stomach contents) through structured observation or the "Questionnaire on Preoperative Fasting Status in Children Undergoing Elective Surgery." Calculate the incidence of PONV = (Number of children experiencing nausea or vomiting within 24 hours post-operation / Total numb

指标中文名：

家长满意度

指标类型：

次要指标

Outcome：

Parent satisfaction

Type：

Secondary indicator

测量时间点：

术后24小时内

测量方法：

测量方法：采用自行设计的家长满意度问卷。该问卷参考了单晓敏等设计的包含四个维度（知识指导、症状管理、流程安排、情感支持）的工具，并依据本研究目的（评估术前禁食管理）进行了条目精简，形成包含8个条目的简化版本。每个条目采用Likert 5级评分法（1=非常不满意，5=非常满意），总分范围8-40分。分数越高，代表满意度越高。）于患儿出院前进行调查。评估与计算方法：在患儿术后24小时内，由研究者向主要监护人指导填写。计算总分及四个维度的平均分。

Measure time point of outcome：

Within 24 hours after surgery

Measure method：

A self-designed parental satisfaction questionnaire was used. It was adapted from a tool by Shan Xiaomin et al. [citation], which originally included four dimensions (knowledge guidance, symptom management, process arrangement, emotional support), and was streamlined for this study's purpose (evaluating preoperative fasting management) into an 8-item simplified version. Each item uses a 5-point Likert scale (1=very dissatisfied, 5=very satisfied), with a total score ranging from 8 to 40. Higher

指标中文名：

患儿覆盖率

指标类型：

次要指标

Outcome：

Child coverage rate

Type：

Secondary indicator

测量时间点：

研究结束时

测量方法：

在研究的干预期内，统计所有实际接受了“6-4-3-2”标准化禁食方案管理的患儿数量。该数据的分子为：在研究期间，其所在病区已启动干预，且其病历或调查记录显示曾接受过新方案宣教或管理的患儿数。分母为：同期所有符合纳入标准的择期手术患儿总数。计算公式：患儿覆盖率 (%) = (实际接受新方案管理的患儿数 / 同期符合条件患儿总数) × 100%。

Measure time point of outcome：

At the end of the study

Measure method：

During the study intervention period, count the total number of children who actually received the standardized "6-4-3-2" fasting protocol management. The numerator of this data is: the number of children whose ward had initiated the intervention during the study period and whose medical records or survey records indicated they had received education or management under the new protocol. The denominator is: the total number of elective surgery children who met the inclusion criteria during the s

指标中文名：

目标医护人员核心培训完成率

指标类型：

次要指标

Outcome：

Core training completion rate for target medical staff

Type：

Secondary indicator

测量时间点：

各阶梯干预期结束后立即统计。

测量方法：

（实际完成培训人数 / 目标医护人员总数）× 100%。

Measure time point of outcome：

Statistics are compiled immediately after each intervention phase.

Measure method：

(Actual number of trained personnel / Total target medical staff) × 100%.

指标中文名：

医护人员知识水平得分

指标类型：

次要指标

Outcome：

Knowledge level score of medical staff

Type：

Secondary indicator

测量时间点：

基线期（培训前），各阶梯干预期结束后（培训后即刻）。

测量方法：

采用《医护人员小儿术前禁食知识水平测试卷》进行评估（前测与后测）。问卷满分100分。主要比较同一批医护人员在培训前后的知识得分差异，采用配对t检验进行统计分析。同时，计算知识合格率（得分≥80分）的变化。该评估旨在检验标准化培训对提升医护人员知识水平的效果。

Measure time point of outcome：

Baseline (pre-training), immediately after each step of the intervention (post-training).

Measure method：

The assessment was conducted using the "Healthcare Professionals' Knowledge Level Test on Pediatric Preoperative Fasting" (pre-test and post-test). The questionnaire had a maximum score of 100 points. The primary comparison was the difference in knowledge scores among the same group of healthcare professionals before and after the training, analyzed using paired t-tests. Additionally, the change in the knowledge pass rate (score ≥80 points) was calculated. This evaluation aimed to examine the ef

指标中文名：

口渴评分

指标类型：

次要指标

Outcome：

Thirst Score

Type：

Secondary indicator

测量时间点：

入手术室前

测量方法：

评估对象：>3岁患儿。 评估方法：采用儿童友好型可视化李克特量表进行评估。该量表由一系列代表不同口渴程度的卡通表情符号构成，从“非常口渴”到“一点也不口渴”，共分为5个等级。在患儿入手术室前，向患儿展示该量表，并询问：“你现在感觉有多渴？”。由患儿自主选择最能代表其口渴感受的表情符号。 评分与记录：每个表情符号对应一个等级分数（例如1-5分，1分代表“一点也不口渴”，5分代表“非常口渴”），记录其口渴等级评分。 数据分析：报告中位数（P25, P75）口渴评分

Measure time point of outcome：

Before entering the operating room

Measure method：

Assessment Subject: Patients >3 years old. Assessment Method: A child-friendly visual Likert scale is used for evaluation. This scale consists of a series of cartoon emojis representing different levels of thirst, ranging from "very thirsty" to "not thirsty at all," divided into 5 levels. Before the patient enters the operating room, the scale is shown to the patient, and the question is asked: "How thirsty do you feel right now?" The patient independently selects the emoji that best represents

指标中文名：

饥饿评分

指标类型：

次要指标

Outcome：

Hunger Score

Type：

Secondary indicator

测量时间点：

入手术室前

测量方法：

评估对象：>3岁患儿。 评估方法：采用儿童友好型可视化李克特量表进行评估。该量表由一系列代表不同饥饿程度的卡通表情符号构成，从“非常饥饿”到“一点也不饿”，共分为5个等级。在患儿入手术室前，向患儿展示该量表，并询问：“你现在感觉有多饿？”。由患儿自主选择最能代表其饥饿感受的表情符号。 评分与记录：每个表情符号对应一个等级分数（例如1-5分，1分代表“一点也不饿”，5分代表“非常饥饿”），记录其饥饿等级评分。 数据分析：报告中位数（P25, P75）饥饿评分。

Measure time point of outcome：

Before entering the operating room

Measure method：

Assessment Subject: Children >3 years old. Assessment Method: A child-friendly visual Likert scale is used for evaluation. This scale consists of a series of cartoon emoticons representing different levels of hunger, ranging from "very hungry" to "not hungry at all," divided into 5 levels. Before the child enters the operating room, the scale is shown to the child, and the question is asked: "How hungry do you feel right now?" The child independently selects the emoticon that best represents th

指标中文名：

哭闹率

指标类型：

次要指标

Outcome：

Crying rate

Type：

Secondary indicator

测量时间点：

入手术室前

测量方法：

评估对象：≤3岁患儿。 评估方法：评估其在禁食禁饮期间是否出现哭闹。在充分排除疼痛、恐惧等其他原因后，若经家长或护理人员安抚超过5分钟仍无法缓解的持续性哭闹，则记录为1次“相关哭闹事件”。 指标计算：统计该年龄组中出现相关哭闹事件的患儿例数，并计算哭闹率（出现哭闹的患儿数 / 该组患儿总数 × 100%）。 数据分析：报告哭闹率（%）。

Measure time point of outcome：

Before entering the operating room

Measure method：

Evaluation subject: Children ≤3 years old. Evaluation method: Assess whether the child exhibits crying during fasting. After fully excluding other causes such as pain or fear, if persistent crying cannot be alleviated after more than 5 minutes of soothing by parents or caregivers, it is recorded as one "relevant crying episode." Indicator calculation: Count the number of children in this age group who experience relevant crying episodes and calculate the crying rate (number of children with cr

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 0 岁 years
最大 Max age 18 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

本研究为阶梯式整群随机试验。 随机序列产生者与方法：邀请一位独立于本研究团队的生物统计学家，使用Excel随机数字表，为纳入研究的10个外科病区（群）产生随机的介入顺序。 随机化过程： a. 从所有符合条件的目标病区中，随机抽取10个病区作为最终研究群组。 b. 将这10个病区随机分配至5个阶梯，每个阶梯包含2个病区。 c. 再随机确定这5个阶梯的启动顺序。整个序列（即哪个病区在第几个阶梯、哪个阶梯在第几个时间点启动）在干预开始前即被锁定。

Randomization Procedure (please state who generates the random number sequence and by what method)：

This study is a stepped-wedge cluster randomized trial. Random sequence generation and method: An independent biostatistician, not affiliated with the research team, was invited to use an Excel random number table to generate a randomized intervention sequence for the 10 surgical wards (clusters) included in the study. Randomization process: a. From all eligible target wards, 10 wards were randomly selected as the final study clusters. b. These 10 wards were randomly allocated into 5 steps, with 2 wards in each step. c. The initiation sequence of these 5 steps was then randomized. The entire sequence (i.e., which ward was assigned to which step and which step was initiated at which time point) was locked before the intervention began.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

无法设盲者：本干预为行为改变策略（推行“6-4-3-2”禁食方案），因此无法对实施干预的医护人员、患儿及家长设盲。 设盲者：为确保结局评估的客观性，本研究对以下人员实施设盲： 结局评估者：负责收集主要结局指标（患儿清饮料禁食依从性）数据的研究员，对病区所处的干预阶段（对照期或干预期）不知情。 数据分析师：负责最终数据统计的分析人员，对分组情况不知情。

Blinding：

Non-blinded participants: This intervention involves a behavioral change strategy (implementing the "6-4-3-2" fasting protocol), making it impossible to blind the healthcare providers, children, and parents involved in the intervention. Blinded participants: To ensure the objectivity of outcome assessments, the following individuals were blinded in this study: Outcome assessors: Researchers responsible for collecting data on the primary outcome (children's compliance with the clear fluid fasting protocol) were unaware of the intervention phase (control or intervention period) of the ward. Data analysts: Personnel conducting the final statistical analysis were unaware of the group assignments.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

本研究收集的、经过去识别化处理的个体参与者数据（包括数据字典），将在本研究的主要结果论文发表后6个月起，在中国临床试验注册中心（ChiCTR）的数据共享平台上公开。数据访问需向ChiCTR提交合理使用申请，并经本研究主要研究者审批。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

The de-identified individual participant data (including data dictionaries) collected in this study will be made publicly available on the data sharing platform of the Chinese Clinical Trial Registry (ChiCTR) starting 6 months after the publication of the main outcome paper of this study. Access to the data requires submission of a reasonable use application to ChiCTR and approval by the principal investigator of this study.

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

本研究将使用纸质病例报告表收集原始数据，内容包括患儿基本信息、末次进食时间、手术信息、临床结局问卷等。所有纸质CRF数据将由经过统一培训的研究员，采用双人独立录入的方式，录入到基于Microsoft Excel构建的标准化电子数据库中。数据库设有逻辑核查规则，并由主要研究者定期进行数据质量核查。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

This study will use paper case report forms to collect raw data, including basic information about the children, the time of last meal, surgical information, clinical outcome questionnaires, etc. All paper CRF data will be entered into a standardized electronic database built on Microsoft Excel by uniformly trained researchers using a double-entry method. The database has logical verification rules and will undergo regular data quality checks by the principal investigator.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-01-09 17:43:55