ChiCTR2300076798 版本V1.1 版本创建时间2024/04/21 20:14:29 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：

 ChiCTR2300076798 

最近更新日期：

Date of Last Refreshed on：

 2023-10-18 16:51:59 

注册时间：

Date of Registration：

 2023-10-18 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于丰富环境理论的患者ICU后综合征预防方案临床应用研究

Public title：

Clinical application of post-ICU syndrome prevention program in patients based on enriched environment theory

注册题目简写：

预防方案临床应用研究

English Acronym：

Study on clinical application of prevention program

研究课题的正式科学名称：

基于丰富环境理论的患者ICU后综合征早期预防方案的构建及初步应用

Scientific title：

Construction and preliminary application of early post-ICU syndrome prevention program in patients based on enriched environment theory

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：

倪萍 

研究负责人：

胡少华 

Applicant：

Ni Ping 

Study leader：

Hu Shaohua 

申请注册联系人电话：

Applicant telephone：

 +86 199 6530 5530

研究负责人电话：

Study leader's
telephone：

+86 139 0969 6207

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：

 ahmunp@163.com

研究负责人电子邮件：

Study leader's E-mail：

 paper2390@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：

安徽省合肥市蜀山区梅山路81号安徽医科大学

研究负责人通讯地址：

安徽省合肥市蜀山区梅山路81号安徽医科大学

Applicant address：

No.81 Meishan Road, Shushan District, Hefei City, Anhui Province, Anhui Medical University

Study leader's address：

No.81 Meishan Road, Shushan District, Hefei City, Anhui Province, Anhui Medical University

申请注册联系人邮政编码：

Applicant postcode：

 230032

研究负责人邮政编码：

Study leader's postcode：

 230032

申请人所在单位：

安徽医科大学护理学院

Applicant's institution：

School of Nursing, Anhui Medical University

研究负责人所在单位：

安徽医科大学护理学院

Affiliation of the Leader：

School of Nursing, Anhui 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：

 84220051

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：

安徽医科大学生物医学伦理委员会

Name of the ethic committee：

Biomedical Ethics Committee, Anhui Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-01-01 00:00:00

伦理委员会联系人：

王华

Contact Name of the ethic committee：

Wang Hua

伦理委员会联系地址：

安徽省合肥市蜀山区梅山路81号安徽医科大学

Contact Address of the ethic committee：

No.81 Meishan Road, Shushan District, Hefei City, Anhui Province, Anhui Medical University

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 551 6516 1057

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：

安徽医科大学护理学院

Primary sponsor：

School of Nursing, Anhui Medical University

研究实施负责（组长）单位地址：

安徽省合肥市蜀山区梅山路81号安徽医科大学

Primary sponsor's address：

No.81 Meishan Road, Shushan District, Hefei City, Anhui Province, Anhui Medical University

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

安徽省

市(区县)：

Country：

China

Province：

Anhui Province

City：

单位(医院)：

安徽医科大学

具体地址：

安徽省合肥市蜀山区梅山路81号安徽医科大学

Institution
hospital：

Anhui Medical University

Address：

No.81 Meishan Road, Shushan District, Hefei City, Anhui Province, Anhui Medical University

经费或物资来源：

安徽省临床重点专科建设项目（皖卫传[2019]91号）

Source(s) of funding：

Clinical Key Specialty Construction Project of Anhui Province (Wanwei Transmission [2019] No. 91)

研究疾病：

重症监护室后综合征  

Target disease：

post-intensive care syndrome

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：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究拟基于丰富环境理论制定ICU患者早期干预方案并初步应用，探讨丰富环境对预防ICU后综合征的效果，旨在帮助医护人员了解丰富环境对预防患者ICU后综合征的效果，为后续指导ICU患者的早期康复锻炼提供实践依据。  

Objectives of Study：

Based on the theory of enriched environment, this study intends to develop early intervention programs for ICU patients and preliminarily apply them and explore the effect of enriched environment on the prevention of post-ICU syndrome, aiming to help medical staff understand the effect of enriched environment on the prevention of post-ICU syndrome, and provide practical basis for the follow-up guidance of early rehabilitation exercises for ICU patients.

药物成份或治疗方案详述：

无 

Description for medicine or protocol of treatment in detail：

Non 

纳入标准：

①入住ICU且意识清楚的患者； ②年龄≥18 岁； ③患者入住ICU前2周的Barthel指数评分≥75分； ④首次入住ICU； ⑤自愿参加并签署知情同意书。

Inclusion criteria

① Patients admitted to ICU with clear consciousness. ② Age ≥18 years old. ③ The Barthel index score of the patient was ≥75 points 2 weeks before ICU admission. ④ First admission to ICU. ⑤ Participate voluntarily and sign informed consent.

排除标准：

①ICU 住院时间＜7 天； ②既往存在肢体、认知、精神、视力、听力功能障碍者； ③不能配合干预及量表测试者； ④可能影响研究结果的疾病，如重度脑外伤、急性神经系统受损事件（如脑血管意外、蛛网膜下腔出血等）； ⑤研究中途退出者。

Exclusion criteria：

①Length of ICU stay < 7 days. ② Previous physical, cognitive, mental, visual, hearing impairment. ③ Can not cooperate with the intervention and scale test. ④ Diseases that may affect the results of the study, such as severe brain trauma, acute nervous system damage events (such as cerebrovascular accidents, subarachnoid hemorrhage, etc.). (5) People who quit during the study.

研究实施时间：

Study execute time：

从 From 2023-10-19 00:00:00至 To 2024-08-15 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-10-19 00:00:00 至 To 2024-08-15 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 40

Group：

Intervention group

Sample size：

干预措施：

一、前期准备 组建团队 A组建由ICU专科护士主导的，ICU医生、呼吸治疗师、康复治疗师、营养师及心理咨询师共同参与的多学科团队，明确成员角色及职责。 B团队成员统一进行严格培训并考核，定期开展老年患者ICU后综合征预防主题会议，组织成员学习并掌握干预的流程及安全标准，为老年患者制定个性化干预方案，讨论干预过程中的问题。 患者评估 A评估患者的文化程度、生活习惯、宗教信仰、家庭状况、认知功能、精神状态、自理能力及语言沟通能力。 B患者入ICU24内，使用Richmond躁动-镇静评分(RASS)或标准化5问题问卷(S5Q)评估其意识状态和配合程度，并根据患者的病情及需求选取非药物干预措施。 镇痛镇静 A疼痛、镇静评估至少每4h进行一次，对于能自主表达的患者使用疼痛数字评分法（NRS），对于不能表达但具有躯体运动功能、行为可以观察的患者使用重症监护疼痛观察工具（CPOT），镇静深度使用Richmond躁动-镇静评分评估。 B遵循优先镇痛、最小化浅镇静原则，控制NRS<4分或CPOT<3分；对于不存在深镇静指标的患者实施浅镇静（RASS-2～1），对于深镇静（RASS<-2）且无唤醒禁忌证的患者实施每日自发觉醒试验（SAT）。 营养支持 A根据患者病情、营养状况、吞咽功能及有无误吸风险，制定个性化营养支持计划，选择合适的营养支持方式。 B对于可经口进食的患者，给予膳食摄入，若患者需要使用义齿，确保义齿功能完好；对于不能经口进食且血流动力学稳定的患者，则给予患者早期（48h内）肠内营养；对于不能经口进食且有肠内营养禁忌证的患者，需在3～7d内启动肠外营养。 二、感觉刺激 视觉刺激 A改善视觉障碍：a评估患者有无视觉障碍；b必要时提供老花镜、放大镜，置于床头并保持清洁；c对于严重视障患者提供对诊疗、护理操作和周围环境的描述；d昏迷或深镇静期间用凡士林纱布覆盖眼部。 B减少不良视觉刺激：a日间(7:00-22:00)拉开窗帘，夜间(22:00-7:00)关闭患者所在病房的顶灯；b其他患者抢救或死亡时使用床帘或屏风遮挡。 C提供眼罩：a评估患者对眼罩的接受性；b夜间(22:00-7:00)或午间休息时（12:00-14:00）使用，治疗、护理或需要时取下。 D丰富视觉刺激：在院感防控的原则下a鼓励患者携带熟悉的物品，如家人的照片、信件或喜欢的书籍等；b根据患者的喜好，提供文字（如报纸、书籍）、视频（如手机视频、电视节目）等；c提供的物品和资料能给予患者积极、正面的引导。 听觉刺激 A改善听觉障碍：a评估患者有无听觉障碍；b必要时提供助听器，置于床头并保持清洁，使用前检查确保功能完好；c与患者沟通时语速缓慢、音量稍大；d对于严重听障患者灵活运用非语言沟通技巧，如使用卡片、手势；e保持耳道清洁。 B减少噪音刺激：a安装分贝监测仪，控制病房噪音水平昼间＜45dB，晚间＜40dB；b护士每班调整监护仪报警范围，合理设置呼吸机等设备的参数及报警范围，及时处理报警，夜间适当降低音量；c医护人员交谈时适当降低音量；d夜间尽可能集中诊疗及护理操作。 C提供耳塞：a评估患者对耳塞接受性；b夜间(22:00- 7:00)或日间需要时使用，治疗、护理或需要时取下。 D丰富听觉刺激：a评估患者对音频的接受性，并通过咨询患者或家属确定患者偏好；b提前下载患者喜爱的音乐和（或）广播节目，并提供MP3播放器和耳机；c每天2次，30min/次（10:00-10:30）（15：00-15:30）。 触觉刺激 A减少身体约束：a动态评估约束的必要性，及时评估并解除导致患者躁动的因素（如排泄、饮食等生理需求及焦虑、恐惧等心理需求）；b对于需要约束的患者，做好解释沟通工作，选择合适的约束工具和/或替代约束工具，最小化身体约束。 B维持正常体温：动态监测患者体温，根据患者的体温及需求提供帽子、棉被、暖风机、冰袋等。 C丰富触觉刺激：在院感防控的原则下a鼓励患者根据喜好携带舒适柔软的靠枕、翻身垫、梳子等；b每日晨（7：40-7:50）辅助患者温水浸泡手足；c每日晨（7：40-8:00）采用适当的压力为患者进行腹部、足底反射区及手部按摩，鼓励配合的患者使用双手或梳子进行头皮按摩。 嗅觉与味觉刺激 A减少刺激性气味：a保持口腔清洁，为患者选择合适的口腔护理液；b定期开窗通风，为有需要的患者提供口罩。 B丰富嗅觉与味觉刺激：a评估患者有无经口进食及芳香疗法禁忌；b鼓励家属根据患者的喜好提供三餐，经常变换食物种类，使用柠檬、醋等丰富食物口味；c根据患者的喜好和需求，提供薰衣草、柑橘、薄荷精油等，每晚睡前取浓度2滴2%的精油滴于纱布，置于患者鼻子下方10cm处，20min/次。 三、运动刺激 评估与准备 A运动刺激评估：每日晨（9:00）评估患者是否符合运动刺激的安全标准，评估患者的疾病进展，心血管、呼吸、神经系统，意识状态（RASS），配合程度（S5Q）、肌力情况及Barthel指数等。 B安全标准：①心血管系统：心率60~130次/min；收缩压90~180mmHg，或平均动脉压60~100mmHg；②呼吸系统：呼吸频率10~40次/min；SpO2＞=88%；FiO2<=0.6，呼气末正压(PEEP)<=10cmH2O；③神经系统：无神经肌肉疾病，无颅内压升高；④无以下情况：新发或有症状的心律失常；考虑心肌缺血；意识的改变，如躁动、不配合；不稳定的脊髓损伤或病变；不稳定性骨折；活动性出血；需加大血管活性药物剂量；人机不同步，需压力控制通气或使用神经肌肉阻滞剂；体温>38.5°C或<36°C。 C减少运动阻碍：a早期活动指导，减轻患者顾虑；b及时清理呼吸道，充足氧气供应；c管道妥善固定，病情允许时尽早拔除；d备齐辅助运动设备、抢救物品及药品。 D丰富运动设备：根据患者的喜好选择运动设备，如三球式呼吸训练器，功率自行车，弹力带，弹力球，气球等。 运动方案 A根据患者的疾病进展、意识状态、配合程度、肌力情况、耐受度及喜好提供运动刺激，鼓励家属参与，每天两次，30min/次（10:30-11:00）（16:30-17:00）。 B被动运动：RASS＜-2/S5Q＜3分时，每2小时改变体位，保持肢体功能位，实施被动关节活动。 C主动结合被动运动：RASS＞=-2/S5Q＞=3分，肌力＜=3级时，鼓励患者进行主动肢体活动；辅助患者练习床上坐位；辅助患者使用被动功率自行车训练。 D主动结合抗阻运动：aRASS＞=-2/S5Q＞=3分，上肢肌力＞3级时，辅助患者练习床边坐位；指导患者进行四肢抗阻训练、呼吸训练及日常生活活动能力（ADL）锻炼。b下肢肌力＞3级时，在上级运动的基础上，协助患者床椅转移、床边站立及离床行走训练；指导患者使用主动功率自行车训练。 四、认知刺激 认知训练 A重新定向：a钟表和日历置于患者床头视线范围内；b护士每班强化患者对人物、时间、地点的认知，告知患者医院名称、住院时间、地点等简短信息。 B提供认知训练游戏：如拼图、象棋、钟表绘画、手指操等，20min/d(9:30-9:50)。 教育与信息支持 A多元化信息支持：a根据患者的文化程度、生活习惯及偏好选择合适的信息支持方式，如面对面口头说明、手册、音频及视频等；b资料内容通俗易懂，材料印刷清晰、使用大号字体，音频吐字清晰、语速缓慢。 B个性化信息支持：a提供ICU相关信息（ICU医护团队的一般信息，日常诊疗和护理操作，相关设备，家属探视信息）；b根据患者的疾病、病程、治疗护理中的主要疑问、目前最主要的健康问题及情感需求等，为患者提供个性化信息支持。 C引导想象和放松疗法：a引导患者将注意力集中在有利的结果上；b指导患者进行深呼吸和肌肉放松训练。 五、社会交往 医患沟通 A鼓励患者与医护人员交流：a鼓励患者表达意愿，耐心倾听，选择患者感兴趣的话题展开讨论；b对于存在沟通障碍的患者，灵活运用非语言沟通技巧，提供纸、笔、写字板、卡片等非语言沟通工具；c对于语言不通的患者可联系家属协助沟通。 B给予患者支持与鼓励：a使用患者习惯的称呼给予患者安全感；b眼神交流、肢体抚摸等方式给予患者心理支持；c与患者握手以示与患者共同努力；d竖起大拇指以示肯定患者的配合和病情好转。 家庭参与 A多元化探视：a尊重患者意愿，选择患者亲近的家属（老伴、子女等）探视；b采用面对面、语音、视频等多种探视方式，线下每次限一到两名家属探视，其余家属通过线上探视（16:00-17:00）；c非探视时间内帮助患者口头转达或通过语音、视频等方式与家属沟通。 B参与心理护理：告知家属ICU特殊环境中老年患者的情感需求及相应的情感安抚技巧，鼓励患者积极配合治疗和护理。 C参与运动刺激：在护士的指导下，家属鼓励并辅助患者的日常生活活动及早期活动。 D参与认知刺激：在护士的指导下，家属a为患者录制鼓励的话语；b带来家人和朋友的信件、照片或视频等；c选择患者感兴趣的话题讨论，内容可涉及家庭事件与回忆、社会新闻等。

干预措施代码：

Intervention：

1.Preparation Build a team. A Set up a multidisciplinary team led by ICU specialist nurses with the participation of ICU doctors, respiratory therapists, rehabilitation therapists, dietitians and psychological counselors to clarify the roles and responsibilities of members. B Team members shall conduct strict training and assessment in a unified manner, hold regular thematic meetings on post-ICU syndrome prevention for elderly patients, organize members to learn and master the intervention process and safety standards, formulate personalized intervention plans for elderly patients, and discuss problems in the intervention process. Patient assessment A Assess the patient's educational level, living habits, religious beliefs, family status, cognitive function, mental state, self-care ability and language communication ability. B Patient admitted to ICU within 24 hours, and they will be assessed for state of consciousness and coordination using the Richmond agitation and sedation score (RASS) or the Standardized 5-question Questionnaire (S5Q). Non-pharmacological interventions were selected according to the patient's condition and needs. Analgesia and sedation A Pain and sedation assessment should be conducted at least every 4h. For patients who can express autonomously, the pain Numerical scale (NRS) should be used; for patients who cannot express but have motor function and observable behavior, the Intensive Care Pain Observation tool (CPOT) should be used; depth of sedation should be evaluated using the Richmond agitation and sedation score. B Follow the principle of priority analgesia and minimal shallow sedation to control NRS<4 points or CPOT<3 marks; Shallow sedation (RASS-2 to 1) was performed for patients without markers of deep sedation, and deep sedation (RASS≤ -2) Daily spontaneous arousal test (SAT) was performed in patients without contraindications of arousal. Nutritional support A According to the patient's condition, nutritional status, swallowing function and unmistakable risk of inhalation, develop a personalized nutritional support plan and choose the appropriate nutritional support. B For patients who can eat orally, give dietary intake, and if the patient needs to use a denture, ensure that the denture is functional; For patients who could not eat orally and had stable hemodynamics, early enteral nutrition (within 48h) was given. For patients who cannot eat orally and have enteral nutrition contraindications, parenteral nutrition should be initiated within 3 to 7 days. 2.Sensory stimulation Visual stimulation A To improve visual impairment: a to assess patients for visual impairment; b If necessary, provide reading glasses and magnifying glasses, put them on the bed and keep them clean; c To provide a description of the diagnosis and treatment, nursing operations, and surrounding environment for severely visually impaired patients; d Cover eyes with Vaseline gauze during coma or deep sedation. B Reduce adverse visual stimulation: a Open the curtains during the day (7:00-22:00), and turn off the overhead light in the patient's ward at night (22:00-7:00); b Use a bed curtain or screen to cover other patients during rescue or death. C Provide an eye mask: a assess the acceptability of the eye mask; b Use at night (22:00-7:00) or during the lunch break (12:00-14:00), and remove as needed for treatment, care or treatment D Enrich visual stimulation: Under the principle of hospital infection prevention and control, a encourages patients to carry familiar items, such as family photos, letters or favorite books; b Provide text (such as newspapers, books), videos (such as mobile phone videos, TV programs), etc., according to the preferences of patients; c provides articles and materials that can give patients positive guidance. Auditory stimulation A To improve hearing impairment: a to assess patients for hearing impairment; b If necessary, provide hearing AIDS, put them on the bed and keep them clean, check before use to ensure that the function is intact; c speaks slowly and loudly when communicating with patients; d For patients with severe hearing impairment, flexible use of non-verbal communication skills, such as cards and gestures; e Keep your ear canal clean. B Reduce noise stimulation: a Install a decibel monitor to control the noise level of the ward < 45dB during the day and < 40dB at night; b Nurses adjust the alarm range of the monitor every shift, reasonably set the parameters and alarm range of ventilators and other equipment, timely handle the alarm, and appropriately reduce the volume at night; c Appropriately reduce the volume of voice when the medical staff is talking; d Concentrate diagnosis, treatment and nursing operations as much as possible at night. C Provide earplugs: a assess patient acceptance of earplugs; b Use at night (22:00-7:00) or during the day as needed, and remove for treatment, care or as needed. D Enrichment of auditory stimuli: a assess patient receptivity to audio and determine patient preferences through consultation with patients or family members; b Download the patient's favorite music and/or radio programs in advance and provide MP3 players and headphones; c 30min/ time, twice a day (10:00-10:30) (15:00-15:30). Tactile stimulation A Reduce physical constraints: a dynamically assess the necessity of constraints, timely assess and remove the factors leading to the patient's agitation (such as excretion, diet and other physiological needs and anxiety, fear and other psychological needs); b For patients who need restraint, do a good job of explaining and communicating, select appropriate restraint tools and/or alternative restraint tools, and minimize physical restraint. B Maintain normal body temperature: dynamically monitor the patient's body temperature, and provide hats, quilts, heaters, ice packs, etc., according to the patient's body temperature and needs. C Rich tactile stimulation: Under the principle of hospital sense prevention and control, a encourages patients to carry comfortable and soft pillows, turning pads, combs, etc., according to their preferences; b Assist patients to soak their hands and feet in warm water every morning (7:40-7:50); c Every morning (7:40-8:00), use appropriate pressure to massage the abdomen, plantar reflex area and hand, and encourage cooperative patients to use both hands or comb for scalp massage. Olfactory and taste stimulation A to reduce irritating odors: a to keep the mouth clean and choose the right oral care solution for the patient; b Open Windows regularly for ventilation and provide masks for patients in need. B To enrich the olfactory and taste stimuli: a to assess whether the patient has oral eating and aromatherapy contraindications; b Encourage family members to provide three meals according to the patient's preferences, change food types frequently, and use lemon, vinegar and other foods to enrich the taste; c According to the preferences and needs of the patient, provide lavender, citrus, peppermint essential oils, etc. Take 2 drops of 2% essential oils and place them on the gauze 10cm below the patient's nose every night before going to bed, 20min/ time. 3.Motor stimulation Assessment and preparation A Exercise stimulation assessment: Every morning (9:00), assess whether the patient meets the safety standards for exercise stimulation, assess the progression of the patient's disease, cardiovascular, respiratory, nervous system, state of consciousness (RASS), degree of coordination (S5Q), muscle strength and Barthel index. B Safety standards: ① Cardiovascular system: heart rate 60~130 beats /min; Systolic blood pressure of 90 to 180mmHg, or mean arterial pressure of 60 to 100mmHg; ② Respiratory system: respiratory rate 10~40 times /min; SpO2 > =88%; FiO2≤0.6, positive end expiratory pressure (PEEP)≤10cmH2O; ③ Nervous system: no neuromuscular disease, no elevated intracranial pressure; ④no: new or symptomatic arrhythmia; Consider myocardial ischemia; Changes in consciousness, such as restlessness and in cooperation; Unstable spinal cord injury or lesion; Unstable fracture; Active bleeding; Vasoactive drug dose should be increased; Man-machine synchronization, pressure control ventilation or use of neuromuscular blockers; Body temperature >38.5°C or< 36°C. C Reduce movement obstruction: a early activity guidance to alleviate patients' concerns; b Timely clearing of respiratory tract, adequate oxygen supply; c The pipe should be properly fixed and removed as soon as possible when the condition permits; d Prepare exercise AIDS, rescue items and medicines. D Enrich exercise equipment: Select exercise equipment according to the preferences of patients, such as three-ball breathing trainers, power bicycles, elastic bands, elastic balls, balloons, etc. Exercise program A Provide exercise stimulation according to the patient's disease progression, state of consciousness, degree of cooperation, muscle strength, tolerance and preference, and encourage family members to participate, 30min/ times (10:30-11:00) (16:30-17:00) twice a day. B Passive movement: when RASS < -2/S5Q < 3, change the position every 2 hours, maintain the functional position of the limbs, and implement passive joint activities. C Active combined with passive exercise: RASS > =-2/S5Q > =3 points, muscle strength < =3, patients are encouraged to carry out active limb activities; Assist the patient to practice sitting position on the bed; Assisted patient with passive power bicycle training. D Actively combined with resistance exercise: a RASS > =-2 or S5Q > =3 points, upper limb muscle strength > level 3, assist the patient to practice bedside sitting position; The patients were instructed to perform resistance training, breathing training and ADL exercises. b When the lower extremity muscle strength is greater than level 3, on the basis of superior exercise, assist the patient in bed chair transfer, bedside standing and walking out of bed training; Instruct patients to use active power bicycle training . 4.Cognitive stimulation Cognitive training A Redirection: a clock and calendar are placed within the line of sight of the patient's bed head; b Nurses strengthen patients' cognition of people, time and place in each shift, and inform patients of short information such as hospital name, hospital stay and place. B Provide cognitive training games such as jigsaw puzzle, chess, clock painting, finger exercises, etc., 20min/d (9:30-9:50). Education and information support A Diversified information support: a selects appropriate information support methods according to the patient's educational level, living habits and preferences, such as face-to-face oral instructions, manuals, audio and video, etc. b The material content is easy to understand, the material printing is clear, the use of large font, the audio text is clear, the speech speed is slow. B Personalized information support: a provide ICU related information (ICU medical team general information, daily diagnosis and nursing operations, related equipment, family visiting information); b Provide personalized information support for patients according to their disease, course of disease, main questions in treatment and nursing, the most important health problems and emotional needs. C Guided visualization and relaxation therapy: a directs the patient to focus on a favorable outcome; b Instruct the patient to perform deep breathing and muscle relaxation exercises. 5.Social interaction Doctor-patient communication A encourages patients to communicate with medical staff: a encourages patients to express their willingness, listen patiently, and choose topics of interest for discussion; b For patients with communication difficulties, flexible use of non-verbal communication skills, paper, pen, writing board, cards and other non-verbal communication tools; c For patients with language difficulties, family members can be contacted to assist in communication. B to give patients support and encouragement: a to use the patient's customary name to give patients a sense of security; b Provide psychological support to patients by means of eye contact and physical touch; c Shake hands with the patient to show joint efforts with the patient; d thumbs up to acknowledge the patient's cooperation and improvement. Family involvement A Diversified visitation: a respects the patient's wishes and chooses close family members (wife, children, etc.) of the patient to visit; b Face to face, voice, video and other visiting methods, offline visits are limited to one or two family members each time, and other family members visit online (16:00-17:00); c Help the patient communicate with family members orally or through voice, video and other means during non-visiting hours. B Participation in psychological care: Inform family members of the emotional needs of elderly patients in the special environment of ICU and the corresponding emotional comfort skills, and encourage patients to actively cooperate with treatment and nursing. C Participation in motor stimulation: Under the guidance of the nurse, the family members encouraged and assisted the patient's daily living activities and early activities. D participated in cognitive stimulation: Under the guidance of the nurse, family member a recorded encouraging word for the patient; b Bring letters, photos or videos from family and friends; c Select topics of interest to the patient, including family events and memories, social news, etc.

Intervention code：

组别：

对照组

样本量：

 40

Group：

Control group

Sample size：

干预措施：

①做好基础及心理护理，妥善安置患者，采取适当体位，保证舒适安全，减轻患者焦虑情绪。 ②持续心电监护，定时观察记录神志、瞳孔、面色、心律及生命体征（呼吸、脉搏、体温、血压），准确记录24小时出入量。 ③妥善处置各引流管并保持通畅，准确记录引流物的颜色、性状和量等。 ④加强病情观察，认真做好记录。病情一旦发生变化，应立即报告医师，及时做出相应处理措施。 ⑤早期康复训练，由ICU护士、呼吸治疗师及康复医师根据患者实际情况实施包括机械通气、体位治疗、气道管理、呼吸肌训练、运动锻炼等常规床旁康复，一周5d，每天1次，每次1h。同时结合常规的X线、CT检查或听诊评估及时调节呼吸机参数及康复方案。 ⑥实施早期肠内营养，注意观察有无胃潴留、腹泻等肠内营养不耐受的表现。

干预措施代码：

Intervention：

① Do a good job of basic and psychological care, properly place patients, take appropriate positions, ensure comfort and safety, and reduce patients' anxiety. ②Continuous ECG monitoring, regular observation and recording of consciousness, pupil, complexion, heart rate and vital signs (breathing, pulse, body temperature, blood pressure), accurate recording of 24-hour intake and outflow. ③ Properly dispose of each drainage tube and keep it unobstructed, and accurately record the color, character and quantity of the drainage. ④ Strengthen the observation of the condition, and carefully make records. Once the condition changes, the doctor should be reported immediately, and the corresponding treatment measures should be made in time. ⑤Early rehabilitation training, including mechanical ventilation, postural therapy, airway management, respiratory muscle training, exercise and other routine bedside rehabilitation, was carried out by ICU nurses, respiratory therapists and rehabilitation physicians according to the actual conditions of patients, 5 days a week, once a day, 1h each time. At the same time, combined with routine X-ray, CT examination or auscultation evaluation, timely adjustment of ventilator parameters and rehabilitation programs. ⑥Implement early enteral nutrition, pay attention to observe whether there is gastric retention, diarrhea and other enteral nutrition intolerance.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 安徽省 

市(区县)：

  

Country：

China

Province：

Anhui Province

City：

单位(医院)：

 安徽医科大学第一附属医院 

单位级别：

 三甲 

Institution
hospital：

The First Affiliated Hospital of Anhui Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

Barthel 指数

指标类型：

主要指标

Outcome：

Barthel Index

Type：

Primary indicator

测量时间点：

干预实施前、转出ICU后2周时

测量方法：

量表评分

Measure time point of outcome：

Before the intervention, and 2 weeks after being transferred out of ICU.

Measure method：

Scale scoring

指标中文名：

匹兹堡睡眠质量指数

指标类型：

主要指标

Outcome：

Pittsburgh Sleep Quality Index

Type：

Primary indicator

测量时间点：

干预实施前、转出ICU后2周时

测量方法：

量表评分

Measure time point of outcome：

Before the intervention, and 2 weeks after being transferred out of ICU.

Measure method：

Scale scoring

指标中文名：

英国医学研究委员会肌力评分

指标类型：

次要指标

Outcome：

Medical Research Council muscle strength score

Type：

Secondary indicator

测量时间点：

干预实施前、转出ICU后2周时

测量方法：

量表评分

Measure time point of outcome：

Before the intervention, and 2 weeks after being transferred out of ICU.

Measure method：

Scale scoring

指标中文名：

简易智能精神状态量表

指标类型：

主要指标

Outcome：

Mini-Mental StateExamination

Type：

Primary indicator

测量时间点：

干预实施前、转出ICU后2周时

测量方法：

量表评分

Measure time point of outcome：

Before the intervention, and 2 weeks after being transferred out of ICU.

Measure method：

Scale scoring

指标中文名：

ICU意识模糊评估法

指标类型：

次要指标

Outcome：

Confusion assessment method for the Intensive Care Unit

Type：

Secondary indicator

测量时间点：

干预实施前、转出ICU后2周时

测量方法：

量表评分

Measure time point of outcome：

Before the intervention, and 2 weeks after being transferred out of ICU.

Measure method：

Scale scoring

指标中文名：

医院焦虑抑郁量表

指标类型：

主要指标

Outcome：

Hospital Anxiety and Depression Scale

Type：

Primary indicator

测量时间点：

干预实施前、转出ICU后2周时

测量方法：

量表评分

Measure time point of outcome：

Before the intervention, and 2 weeks after being transferred out of ICU.

Measure method：

Scale scoring

指标中文名：

事件影响量表-修订版

指标类型：

主要指标

Outcome：

Impact of events scale-revised

Type：

Primary indicator

测量时间点：

干预实施前、转出ICU后2周时

测量方法：

量表评分

Measure time point of outcome：

Before the intervention, and 2 weeks after being transferred out of ICU.

Measure method：

Scale scoring

指标中文名：

ICU住院天数

指标类型：

次要指标

Outcome：

Length of ICU stay

Type：

Secondary indicator

测量时间点：

出科当天

测量方法：

出科日期减入科时间

Measure time point of outcome：

Graduation day

Measure method：

The date of discharge is reduced to the time of admission.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

non

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 18 岁 years
最大 Max age 85 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）：

研究者通过随机数字网站（http://tools.medsci.cn/rand）产生80个随机序列，将该序列从小到大排序，前40个为干预组，后40个为对照组。

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

Researchers produced by random number website (http://tools.medsci.cn/rand) 80 random sequences, the sequence from small to large, sorting before 40 as intervention group, after 40 in the control group.

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：

单盲：通过第三方数据收集者负责患者的基线、干预前和转出ICU后2周的数据收集且数据收集者不清楚患者所在的研究组，避免主观臆想对试验结果的影响。 患者对于自身分在对照组还是干预组并不知情，避免心理效应产生偏倚影响结果。

Blinding：

Single blinded: use a third-party data collector to collect data at baseline, before intervention, and 2 weeks after transferring out of the ICU without knowing which study group the patient was in to avoid subjectively influencing the results of the trial. Patients do not know whether they are in the control group or the intervention group, so as to avoid the bias of psychological effects affecting the results.

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）：

无

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

non

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：

病例记录表

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

Case Record Form, CRF

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：

  2023-10-18 16:51:13