中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600117675
最近更新日期： Date of Last Refreshed on：	2026-01-27 16:47:09
注册时间： Date of Registration：	2026-01-27 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	失效模式与效应分析联合体验式护理对全麻手术患者苏醒质量及心理状态影响
Public title：	Effects of Failure Mode and Effects Analysis Combined with Experiential Nursing on Recovery Quality and Psychological Status in Patients Undergoing General Anesthesia Surgery
注册题目简写：
English Acronym：
研究课题的正式科学名称：	失效模式与效应分析联合体验式护理对全麻手术患者苏醒质量及心理状态影响
Scientific title：	Effects of Failure Mode and Effects Analysis Combined with Experiential Nursing on Recovery Quality and Psychological Status in Patients Undergoing General Anesthesia Surgery
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：	许丹丹	研究负责人：	葛经武
Applicant：	Dan-Dan Xu	Study leader：	Jing-Wu Ge
申请注册联系人电话： Applicant telephone：	+86 136 2513 6341	研究负责人电话： Study leader's telephone：	+86 130 1449 8967
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：	13625136341@163.com	研究负责人电子邮件： Study leader's E-mail：	jsgjw2009@163.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：	南京医科大学第一附属医院,江苏省南京市鼓楼区广州路300号	研究负责人通讯地址：	南京医科大学第一附属医院,江苏省南京市鼓楼区广州路300号
Applicant address：	The First Affiliated Hospital of Nanjing Medical University, No. 300 of GuangZhou Road, Gulou District, Nanjing, Jiangsu Province,210000,China	Study leader's address：	The First Affiliated Hospital of Nanjing Medical University, No. 300 of GuangZhou Road, Gulou District, Nanjing, Jiangsu Province,210000,China
申请注册联系人邮政编码： Applicant postcode：		研究负责人邮政编码： Study leader's postcode：
申请人所在单位：	南京医科大学第一附属医院
Applicant's institution：	The First Affiliated Hospital with Nanjing Medical University
研究负责人所在单位：	南京医科大学第一附属医院
Affiliation of the Leader：	The First Affiliated Hospital with Nanjing Medical University

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：	2024-SR-965	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：	南京医科大学第一附属医院伦理委员会
Name of the ethic committee：	The First Affiliated Hospital with Nanjing Medical University
伦理委员会批准日期： Date of approved by ethic committee：	2025-03-03 00:00:00
伦理委员会联系人：	赵俊
Contact Name of the ethic committee：	JUN ZHAO
伦理委员会联系地址：	江苏省南京市鼓楼区广州路300号
Contact Address of the ethic committee：	No. 300 of GuangZhou Road, Gulou District, Nanjing, Jiangsu Province,210000,China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 136 2513 6341	伦理委员会联系人邮箱： Contact email of the ethic committee：

研究实施负责（组长）单位：

南京医科大学第一附属医院

Primary sponsor：

The First Affiliated Hospital with Nanjing Medical University

研究实施负责（组长）单位地址：

江苏省南京市鼓楼区广州路300号

Primary sponsor's address：

No. 300 of GuangZhou Road, Gulou District, Nanjing, Jiangsu Province,210000,China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	南京	市(区县)：	南京
Country：	China	Province：	Jiangsu	City：	Nanjing
单位(医院)：	南京医科大学第一附属医院	具体地址：	江苏省南京市鼓楼区广州路300号
Institution hospital：	The First Affiliated Hospital with Nanjing Medical University	Address：	No. 300 of GuangZhou Road, Gulou District, Nanjing, Jiangsu Province,210000,China

经费或物资来源：

无

Source(s) of funding：

None

研究疾病：

全麻苏醒期患者

Target disease：

Recovery Quality and Psychological Status in Patients Undergoing General Anesthesia

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：

随机平行对照

Study design：

Parallel

研究目的：

探究失效模式与效应分析联合体验式护理对全麻手术患者苏醒质量及心理状态影响，探究心理干预对患者复苏期苏醒质量的影响

Objectives of Study：

To explore the effects of failure mode and effects analysis combined with experiential care on recovery quality and psychological status in patients undergoing general anesthesia surgery.

药物成份或治疗方案详述：

本研究旨在分析失效模式与效应分析联合体验式护理在全麻手术患者中的效果，通过随机、单盲及前瞻性平行对照试验，分析失效模式与效应分析联合体验式护理对麻醉复苏效果的影响。共分为2组，分别为常规护理组和试验组，对患者和数据收集者采用盲法，方案如下。方案：（1）常规护理组：常规护理组实施常规围术期麻醉护理。术前一天由麻醉护士进行常规术前访视，核对患者身份及手术信息，向患者介绍手术及麻醉相关注意事项，解答患者疑问，并给予一般性心理安抚。手术当日患者进入手术间后再次核对信息，协助麻醉医生完成麻醉诱导与维持，护理过程中操作轻柔，注意患者隐私保护及保暖，协助摆放合适体位并固定，确保各类导联线及输液通路通畅。术中密切监测患者生命体征，遵医嘱协助实施镇痛及其他麻醉管理措施。术后患者进入麻醉复苏室，根据手术及麻醉情况采取合适体位，协助清理呼吸道分泌物，做好呼吸道管理，持续监测生命体征及苏醒情况。患者苏醒后生命体征平稳，符合出室标准后，遵医嘱护送患者返回病房。（2）试验组：试验组在常规护理基础上，实施融合失效模式与效应分析（FMEA）与体验式护理的围术期麻醉护理模式。该模式以围术期护理流程为主线，通过风险前瞻管理与患者体验优化相结合的方式开展护理干预。首先构建麻醉护理风险管理小组：成立围术期麻醉护理风险管理小组，由1名麻醉医生及3名麻醉护士组成，均具有5年以上临床工作经验，熟悉围术期麻醉护理流程。小组成员系统查阅相关文献，结合科室临床实践，对全麻围术期护理流程进行梳理，明确可能影响患者苏醒质量的关键护理环节。其次，严格遵循失效模式—失效原因—失效后果—控制措施的分析流程，并引入风险优先数（risk priority number，RPN）对围术期麻醉护理中潜在失效风险进行量化评估。RPN由失效发生概率（occurrence，O）、失效严重度（severity，S）及失效可探测性（detectability，D）三个维度评分相乘得到，即RPN＝O×S×D。其中，O用于评估某一护理失效在围术期发生的可能性；S用于评估该失效一旦发生对患者安全、苏醒质量及预后造成的潜在危害程度；D用于评估在失效造成不良后果前被及时发现和纠正的难易程度。各维度评分均采用1～10分等级法，分值越高表示风险越大。根据RPN值对各护理失效模式进行排序，将RPN值较高的环节列为重点风险控制对象，并优先制定针对性的护理干预与改进措施。

Description for medicine or protocol of treatment in detail：

This study aims to analyze the effects of combining Failure Mode and Effects Analysis (FMEA) with experiential nursing in patients undergoing general anesthesia. Through a randomized, single-blind, and prospective parallel controlled trial, the impact of FMEA combined with experiential nursing on anesthesia recovery outcomes was investigated. Participants were divided into two groups: the conventional care group and the experimental group. Both patients and data collectors were blinded to the group assignments. The protocols are as follows. Protocol: (1) Conventional Care Group: The conventional care group received standard perioperative anesthesia care. One day before surgery, an anesthesia nurse conducted a routine preoperative visit to verify the patient’s identity and surgical information, explain surgical and anesthesia-related precautions, address patient questions, and provide general psychological reassurance. On the day of surgery, patient information was reconfirmed upon entering the operating room, and the nurse assisted the anesthesiologist in completing anesthesia induction and maintenance. During the procedure, care was delivered gently, with attention to privacy protection and warmth maintenance. The nurse assisted in positioning and securing the patient appropriately, ensuring the patency of all leads and infusion lines. Vital signs were closely monitored intraoperatively, and analgesic and other anesthesia management measures were implemented as per medical orders. After surgery, patients were transferred to the post-anesthesia care unit (PACU). Based on the surgical and anesthesia conditions, an appropriate position was adopted, and the nurse assisted in clearing respiratory secretions, managed the airway, and continuously monitored vital signs and recovery progress. Once the patient regained consciousness with stable vital signs and met the discharge criteria, they were escorted back to the ward according to medical orders. (2) Experimental Group: In addition to conventional care, the experimental group received a perioperative anesthesia care model integrating Failure Mode and Effects Analysis (FMEA) and experiential nursing. This model centered on the perioperative nursing process and implemented nursing interventions by combining prospective risk management with patient experience optimization. First, an anesthesia nursing risk management team was established: a perioperative anesthesia nursing risk management team was formed, consisting of one anesthesiologist and three anesthesia nurses, all with over five years of clinical experience and familiarity with perioperative anesthesia care processes. Team members systematically reviewed relevant literature and, based on departmental clinical practice, analyzed the general anesthesia perioperative care process to identify key nursing steps that could affect patient recovery quality. Second, the analytical process of failure mode → failure cause → failure consequence → control measures was strictly followed, and the Risk Priority Number (RPN) was introduced to quantitatively assess potential failure risks in perioperative anesthesia nursing. The RPN was calculated by multiplying the scores of three dimensions: Occurrence (O), Severity (S), and Detectability (D), i.e., RPN = O × S × D. Here, O evaluates the likelihood of a nursing failure occurring during the perioperative period; S assesses the potential harm to patient safety, recovery quality, and prognosis if the failure occurs; and D evaluates the difficulty of detecting and correcting the failure before it leads to adverse consequences. Each dimension was scored on a scale of 1 to 10, with higher scores indicating greater risk. Nursing failure modes were ranked based on their RPN values, and steps with higher RPN values were identified as key risk control targets. Priority was given to developing targeted nursing interventions and improvement measures for these high-risk areas.

纳入标准：

Inclusion criteria

排除标准：

合并感染性疾病、免疫功能缺陷者，行局部麻醉或吸入麻醉者，合并严重系统性疾病者，合并恶液质者，合并药物依赖、酒精滥用者。

Exclusion criteria：

Patients with combined infectious diseases, immune deficiency, local anesthesia or inhalation anesthesia, severe systemic diseases, cachexia, drug dependence and alcohol abuse.

研究实施时间：

Study execute time：

从 From 2026-03-01 00:00:00至 To 2026-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-03-01 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：	对照组	样本量：	60
Group：	control group	Sample size：	60
干预措施：	常规围术期麻醉护理	干预措施代码：
Intervention：	Routine perioperative anesthesia care	Intervention code：

组别：	试验组	样本量：	60
Group：	experimental group	Sample size：	60
干预措施：	在常规围术期麻醉护理的基础上接受失效模式与效应分析联合体验式护理，提前对围术期风险进行预测，制定完善的护理干预措施，并直接进行干预，进一步降低风险的发生率，同时在术前访视过程中通过图片、视频及纸质宣教单告知患者围术期大致流程，使患者有心理预期，提前建立心理防御机制。	干预措施代码：
Intervention：	Building upon standard perioperative anesthesia care, we implement a failure mode and effect analysis (FMEA) combined with experiential nursing to proactively predict perioperative risks. This enables the formulation of comprehensive nursing interventions that directly reduce risk occurrence rates. During preoperative consultations, patients receive visual aids including images, videos, and printed educational materials detailing the surgical process. These measures help establish psychological preparedness and build protective mental mechanisms in advance.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	南京	市(区县)：	南京
Country：	China	Province：	Jiangsu	City：	Nanjing
单位(医院)：	南京医科大学第一附属医院	单位级别：	三甲
Institution hospital：	The First Affiliated Hospital with Nanjing Medical University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	患者在麻醉复苏室的总时间	指标类型：	主要指标
Outcome：	Total time the patient spent in the anesthesia recovery room	Type：	Primary indicator
测量时间点：	入复苏室到出复苏室	测量方法：
Measure time point of outcome：	Total time the patient spent in the anesthesia recovery room	Measure method：

指标中文名：	患者的焦虑自评量表（SAS）	指标类型：	主要指标
Outcome：	Patients' anxiety Self-Rating Scale (SAS)	Type：	Primary indicator
测量时间点：	患者入室时、患者苏醒后、患者出室前	测量方法：
Measure time point of outcome：	When the patient enters the room, when the patient wakes up, and before the patient leaves the room	Measure method：

指标中文名：	采用中文版Hawkins全身麻醉患者满意度问卷对患者进行护理满意度调查	指标类型：	附加指标
Outcome：	The Chinese version of Hawkins general anesthesia patient satisfaction questionnaire was used to investigate the nursing satisfaction of patients	Type：	Additional indicator
测量时间点：	患者入室时、患者苏醒后、患者出室前	测量方法：
Measure time point of outcome：	When the patient enters the room, when the patient wakes up, and before the patient leaves the room	Measure method：

指标中文名：	ASA分级	指标类型：	主要指标
Outcome：	ASA Grade	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	基础疾病	指标类型：	主要指标
Outcome：	Basic diseases	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	拔管时间	指标类型：	主要指标
Outcome：	Extubation time	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	入复苏室30min生命体征	指标类型：	主要指标
Outcome：	Vital signs at 30 minutes post-admission to the recovery room**	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	出室时间	指标类型：	主要指标
Outcome：	Discharge time from the recovery room	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	苏醒后FAVS评分	指标类型：	主要指标
Outcome：	FAVS Score Upon Recovery from Anesthesia	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	SDS评分	指标类型：	主要指标
Outcome：	SDS Score	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	疼痛评分	指标类型：	主要指标
Outcome：	Pain Score	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	躁动情况及满意度	指标类型：	主要指标
Outcome：	Agitation level and satisfaction.	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	无	组织：
Sample Name：	None	Tissue：
人体标本去向	其它	说明
Fate of sample：	0thers	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		岁 years
最大 Max age		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）：

随机数字表法

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

Random Number Table Method

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：	本研究采用单盲法。 1.对患者设盲：所有患者均被告知将接受“优化的围术期麻醉护理”，但不被告知其所属具体组别及另一组别的存在，以避免患者因知晓分组而产生心理暗示效应。 2.对数据收集者/结局评估者设盲：负责记录苏醒时间、生理指标、心理量表评分、满意度问卷等所有观察指标的评估人员，不参与两组患者的围术期护理干预过程，且不知晓患者的具体分组。 3.未设盲人员：实施具体护理干预的麻醉医生及麻醉护士由于需要执行不同的护理方案，无法对其设盲。为防止沾染，研究方案明确规定了不同组别的标准化操作流程，并在不同时段或手术间安排患者，以最大限度减少两组护理措施间的相互影响。 4.数据统计阶段：数据分析由独立的统计人员在盲态下进行，所有数据均以组别代码（如A组、B组）形式提交，直至分析完成后才揭晓组别对应关系。
Blinding：	This study employed a single-blind design. Blinding of Patients: All patients were informed that they would receive "optimized perioperative anesthesia care," but they were not told their specific group assignment or the existence of another group. This was done to avoid any psychological suggestive effects that knowledge of their group allocation might produce. Blinding of Data Collectors/Outcome Assessors: The assessors responsible for recording all outcome measures—including recovery times, physiological parameters, psychological scale scores, and satisfaction questionnaires—did not participate in the perioperative nursing interventions for either group and were unaware of the patients' specific group assignments. Unblinded Personnel: The anesthesiologists and anesthesia nurses who implemented the specific nursing interventions could not be blinded due to the need to execute different care protocols. To prevent contamination, the study protocol clearly defined standardized operating procedures for each group. Patients were scheduled in different time slots or operating rooms to minimize any potential crossover or interaction between the nursing measures of the two groups. Data Analysis Phase: Data analysis was conducted by an independent statistician under blinded conditions. All data were submitted using group codes (e.g., Group A, Group B). The correspondence between the codes and the actual group assignments (experimental vs. conventional care) was revealed only after the analysis was completed.
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	是Yes
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）：	试验结束后6个月内可共享原始数据，初步打算可在相关公共平台共享
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	The original data can be shared within 6 months after the end of the trial, and it is preliminarily planned to be shared on relevant public platforms
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：	完成纸质版问卷后，由课题组成员进行数据录入，录入完毕后与原始记录核对，以确保数据准确性。调查前与研究对象充分沟通问卷调查结果均用于本次研究使用，无其他任何盈利性目的，且对研究之外人员保密。获得研究对象同意后签署知情同意书。调查资料存在保密的移动硬盘中，并保存在有锁的档案柜中，且仅供研究人员或政府管理部门或伦理委员会成员（必要时）按照规定进行查阅。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	After completing the paper questionnaire, the research team will enter the data. Upon completion, the data will be cross-checked with the original records to ensure accuracy. Prior to the survey, participants were fully informed that all questionnaire results would be used exclusively for this study without any commercial purposes and would remain confidential from non-research personnel. Participants signed an informed consent form after giving their consent. The survey materials are stored on secure mobile hard drives in a locked filing cabinet, accessible only to researchers, government regulators, or ethics committee members (when necessary) under strict protocol
数据与安全监察委员会： Data and Safety Monitoring Committee：	暂未确定/Not yet
注册人： Name of Registration：	2026-01-27 16:47:04