ChiCTR2400081203 版本V1.0 版本创建时间2024/02/26 14:44:41 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：

ChiCTR2400081203 

最近更新日期：

Date of Last Refreshed on：

2024-02-26 14:44:37 

注册时间：

Date of Registration：

2024-02-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

气管插管拔管后早期含服少量冰块对于减轻患者口渴和咽痛的影响

Public title：

The Effectiveness of Ice Cube Oral Administration on Reducing Thirst Intensity and Sore Throat in the Early Period after Extubation

注册题目简写：

English Acronym：

研究课题的正式科学名称：

气管插管拔管后早期含服少量冰块对于减轻患者口渴和咽痛的影响

Scientific title：

The Effectiveness of Ice Cube Oral Administration on Reducing Thirst Intensity and Sore Throat in the Early Period after Extubation

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：

任宣霖 

研究负责人：

樊落 

Applicant：

Xuanlin Ren 

Study leader：

Fan Luo 

申请注册联系人电话：

Applicant telephone：

+86 183 9400 8092

研究负责人电话：

Study leader's telephone：

+86 139 0931 6149

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：

270163600@qq.com

研究负责人电子邮件：

Study leader's E-mail：

2569869312@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：

甘肃省兰州市城关区东岗西路1号

研究负责人通讯地址：

甘肃省兰州市城关区东岗西路1号

Applicant address：

1 Donggang Road West, Chengguan District, Lanzhou, Gansu

Study leader's address：

1 Donggang Road West, Chengguan District, Lanzhou, Gansu

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：

兰州大学第一医院

Applicant's institution：

First Hospital of Lanzhou University

研究负责人所在单位：

兰州大学第一医院

Affiliation of the Leader：

First Hospital of Lanzhou University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

LDYYLL2024-23

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：

兰州大学第一医院临床研究伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Medical Ethics Committee of Gansu Provincial People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024-01-15 00:00:00

伦理委员会联系人：

李秋杉

Contact Name of the ethic committee：

Qiushan Li

伦理委员会联系地址：

甘肃省兰州市城关区东岗西路1号

Contact Address of the ethic committee：

1 Donggang Road West, Chengguan District, Lanzhou, Gansu

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 931 894 8648

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：

兰州大学第一医院

Primary sponsor：

First Hospital of Lanzhou University

研究实施负责（组长）单位地址：

甘肃省兰州市城关区东岗西路1号

Primary sponsor's address：

1 Donggang Road West, Chengguan District, Lanzhou, Gansu

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

甘肃

市(区县)：

兰州

Country：

China

Province：

Gansu

City：

Lanzhou

单位(医院)：

兰州大学第一医院

具体地址：

甘肃省兰州市城关区东岗西路1号

Institution
hospital：

First Hospital of Lanzhou University

Address：

1 Donggang Road West, Chengguan District, Lanzhou, Gansu

经费或物资来源：

甘肃省卫生健康委员会

Source(s) of funding：

The Health Commission of Gansu Province(grant number: GSWSHL2022-01)

Target disease：

None

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：

本研究目的是比较气管插管拔除后口腔护理后早期给予少量冰块含服与常规进行口腔护理后继续禁食6小时 (常规护理)缓解ICU患者口渴强度、口渴不适、咽喉疼痛、口咽部不适感的有效性。  

Objectives of Study：

The objective of this study was to compare the effectiveness of early oral care after tracheal intubation removal with that of continuous fasting for 6 hours after routine oral care (conventional care) in relieving thirst intensity, thirst discomfort, sore throat, and oropharyngeal discomfort in ICU patients.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. 年龄介乎18至65岁; 2. 气管插管前无咽部疾病或疼痛; 3. 清醒或镇静评分(RASS)为-2至1的患者 4. 自愿参与研究并签署知情同意书。

Inclusion criteria

1. Aged between 18 and 65 years; 2. No pharyngeal disease or pain before endotracheal intubation; 3. Patients with an awareness or sedation score (RASS) of -2 to 1; 4. Who were cooperative, voluntarily entered the study and signed informed consent were eligible.

排除标准：

（1）既往存在认知障碍或沟通障碍; （2）在ICU住院期间使用鼻腔气管内管(即仅包括口腔气管插管); （3）目前或既往气管切开术; （4）由于医疗条件或手术原因无法通过口腔进食或喝水; （5）不能耐受冰; （6）拔管后生命体征不稳定且危及生命； （7）既往存在或同时存在影响吞咽功能的其他疾病，如头颈部手术或创伤、口咽或食道肿瘤、神经肌肉疾病。

Exclusion criteria：

(1) Preexisting cognitive impairment or communication barrier, (2) Used of nasal endotracheal tube during their ICU stay (i.e., only oral trachea tube was included), (3) Current or prior tracheotomy, (4) Unable to eat or drink by mouth due to medical condition or surgery, (5) Couldn’t tolerate ice, (6) Unstable and life-threatening vital signs after extubation, (7) Pre-existing or co-existing other conditions affecting swallowing function, such as head and neck surgery or trauma, oropharyngeal or esophageal tumors, neuromuscular disease.

研究实施时间：

Study execute time：

从 From 2024-02-01 00:00:00至 To 2024-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-03-01 00:00:00 至 To 2024-05-01 00:00:00  

干预措施：

Interventions：

组别：

1

样本量：

52

Group：

1

Sample size：

干预措施：

使用临床常规拔管后口咽部护理方法，ICU室温控制在22~24℃,湿度控制在50%~60%,病情允许者,床头抬高≥30°,使用氯己定漱口液进行口腔护理每6 h 1次,口腔护理时责任护士使用无菌棉签蘸取温水湿润病人口唇及口腔。于患者拔管后6小时饮水，对生命体征进行监测。

干预措施代码：

 CG

Intervention：

Clinical routine oropharyngeal care after extubation was used, ICU room temperature was controlled at 22~24℃, humidity was controlled at 50%~60%, the bedside elevation was ≥30° if the condition permitted, chlorhexidine mouthwash was used for oral care once every 6 hours, and the nurse in charge of oral care used a sterile cotton swab dipped in warm water to moisten the patient's lips and mouth. The patient drank water 6 hours after extubation, and the vital signs were monitored.

Intervention code：

组别：

2

样本量：

52

Group：

2

Sample size：

干预措施：

在常规护理的基础上接受冰刺激疗法, 具体操作如下: ①团队成员每日制冰,即将灭菌注射灌注至冻冰食品级硅胶模具中,并将其放置于冰箱冷冻层备用，每块冰块为5ml水冻成的半球形冰块；②责任护士在气管拔管后使用氯己定漱口液为病人进行口腔护理,操作后根据患者插管持续时间、精神状态、自身意愿、易发生吞咽困难的潜在合并症（例如，神经肌肉疾病、重症肌病、意识水平差）等因素，采取个体化冰块含服时间策略。确保在拔管15分钟给予患者两块冰块含服，并在此过程中进行密切监测，对于需要恢复机械通气患者重新插管。

干预措施代码：

 EG

Intervention：

On the basis of routine care, the team members received ice stimulation therapy, the specific operations were as follows: (1) The team members made ice every day, that is, injected sterilization into the frozen food-grade silicone mold, and placed it in the freezer for use. Each ice cube was a hemisphical ice cube frozen with 5ml water; ② The responsible nurse used chloracetine gargling solution to provide oral care to the patient after trachea extubation. After the operation, individualized ice dosage time strategy was adopted according to the patient's intubation duration, mental state, willingness, potential complications of dysphagia (e.g., neuromuscular disease, myopathy gravis, poor level of consciousness) and other factors. On the basis of routine care, the team members received ice stimulation therapy, the specific operations were as follows: (1) The team members made ice every day, that is, injected sterilization into the frozen food-grade silicone mold, and placed it in the freezer for use. Each ice cube was a hemisphical ice cube frozen with 5ml water; ② The responsible nurse used chloracetine gargling solution to provide oral care to the patient after trachea extubation. After the operation, individualized ice dosage time strategy was adopted according to the patient's intubation duration, mental state, willingness, potential complications of dysphagia (e.g., neuromuscular disease, myopathy gravis, poor level of consciousness) and other factors. Ensure that the patient is given two ice cubes within 15 minutes of extubation, monitored closely during this process, and reintubated for patients who need to resume mechanical ventilation. Ensure that the patient is given two ice cubes within 15 minutes of extubation, monitored closely during this process, and reintubated for patients who need to resume mechanical ventilation.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 甘肃 

市(区县)：

 兰州 

Country：

China 

Province：

Gansu 

City：

Lanzhou 

单位(医院)：

兰州大学第一医院 

单位级别：

三甲 

Institution
hospital：

First Hospital of Lanzhou University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

口渴强度

指标类型：

主要指标

Outcome：

intensity of thirst

Type：

Primary indicator

测量时间点：

于气管拔管、拔管后15分钟、拔管后45分钟进行评估

测量方法：

视觉模拟评分法

Measure time point of outcome：

Evaluation was performed at tracheal extubation, 15 minutes after extubation, and 45 minutes after extubation

Measure method：

Numerical Rating Scale

指标中文名：

咽痛程度

指标类型：

主要指标

Outcome：

sore throat

Type：

Primary indicator

测量时间点：

于气管拔管、拔管后15分钟、拔管后45分钟进行评估

测量方法：

视觉模拟评分法

Measure time point of outcome：

Evaluation was performed at tracheal extubation, 15 minutes after extubation, and 45 minutes after extubation

Measure method：

Numerical Rating Scale

指标中文名：

口咽不适感

指标类型：

次要指标

Outcome：

oropharyngeal discomfort

Type：

Secondary indicator

测量时间点：

于气管拔管、拔管后15分钟、拔管后45分钟进行评估

测量方法：

视觉模拟评分法

Measure time point of outcome：

Evaluation was performed at tracheal extubation, 15 minutes after extubation, and 45 minutes after extubation

Measure method：

Numerical Rating Scale

指标中文名：

口渴不适感

指标类型：

次要指标

Outcome：

thirst discomfort

Type：

Secondary indicator

测量时间点：

于气管拔管、拔管后15分钟、拔管后45分钟进行评估

测量方法：

围手术期口渴不适量表

Measure time point of outcome：

Evaluation was performed at tracheal extubation, 15 minutes after extubation, and 45 minutes after extubation

Measure method：

Perioperative Thirst Discomfort Scale

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 18 岁 years
最大 Max age 65 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）：

我们将患者随机分为两组(CG和EG)，采用1:1设计，块大小为6。研究护士使用GraphPad软件(GraphPad Software, Inc.)生成随机数列。我们将患者随机分为两组(CG和EG)，采用1:1设计。研究护士使用GraphPad软件(GraphPad Software, Inc.)生成随机分配序列。在研究开始前，将其密封在单独的不透明信封中，并将它们交付给两个单位。护理人员打开信封。所有其他参与者(数据收集者和分析师)对研究任务不知情。

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

We randomly assigned patients into two groups (CG and EG), with a 1:1 design and block sizes of 6. A research nurse generated the random allocation sequence using GraphPad Software (GraphPad Software, Inc. La Jolla, CA) before the study commencement, sealed it in individual opaque envelopes, and delivered them to two units. The nursing staff unsealed the envelopes. All other parties involved (data collectors and analysts) were blinded to the study assignments.

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：

护理人员打开信封。所有其他参与者(数据收集者和分析师)对研究任务不知情。

Blinding：

All other participants (data collectors and analysts) were unaware of the research task.

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

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）：

发表论文

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

Publish an article

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：

  2024-02-26 14:44:37