ChiCTR2600118708 版本V1.0 版本创建时间2026/02/10 10:46:02 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：

 ChiCTR2600118708 

最近更新日期：

Date of Last Refreshed on：

 2026-02-10 10:45:54 

注册时间：

Date of Registration：

 2026-02-10 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Effectiveness of Inspiratory Muscle Training on Dyspnea and Fatigue among Critically-Ill Burn Patients Receiving High-Flow Nasal Oxygen Therapy: A Randomized Controlled Trial

Public title：

Effectiveness of Inspiratory Muscle Training on Dyspnea and Fatigue among Critically-Ill Burn Patients Receiving High-Flow Nasal Oxygen Therapy: A Randomized Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Effectiveness of Inspiratory Muscle Training on Dyspnea and Fatigue among Critically-Ill Burn Patients Receiving High-Flow Nasal Oxygen Therapy: A Randomized Controlled Trial

Scientific title：

Effectiveness of Inspiratory Muscle Training on Dyspnea and Fatigue among Critically-Ill Burn Patients Receiving High-Flow Nasal Oxygen Therapy: A Randomized Controlled Trial

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：

Zahraa Fayyadh Abd Hussein 

研究负责人：

Zahraa Fayyadh Abd Hussein 

Applicant：

Zahraa Fayyadh Abd Hussein 

Study leader：

Zahraa Fayyadh Abd Hussein 

申请注册联系人电话：

Applicant telephone：

 +964 774 568 8864

研究负责人电话：

Study leader's
telephone：

+964 774 568 8864

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：

 zahraa.faiad1704a@conursing.uobaghdad.edu.iq

研究负责人电子邮件：

Study leader's E-mail：

 zahraa.faiad1704a@conursing.uobaghdad.edu.iq

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：

Al-Shaab, Al-Diwan, Street 40, Baghdad, Iraq

研究负责人通讯地址：

Al-Shaab, Al-Diwan, Street 40, Baghdad, Iraq

Applicant address：

Al-Shaab, Al-Diwan, Street 40, Baghdad, Iraq

Study leader's address：

Al-Shaab, Al-Diwan, Street 40, Baghdad, Iraq

申请注册联系人邮政编码：

Applicant postcode：

 10045

研究负责人邮政编码：

Study leader's postcode：

 10045

申请人所在单位：

University of Baghdad/ College of Nursing/ Department of Adult Nursing

Applicant's institution：

University of Baghdad/ College of Nursing/ Department of Adult Nursing

研究负责人所在单位：

College of Nursing, University of Baghdad

Affiliation of the Leader：

College of Nursing, University of Baghdad

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：

 17/ 10-11-2025

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：

Research Ethical Approval Committee- College of Nursing, University of Baghdad

Name of the ethic committee：

Research Ethical Approval Committee- College of Nursing, University of Baghdad

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-11-10 00:00:00

伦理委员会联系人：

Associate Prof. Wafaa Abd Ali Hattab, Ph.D

Contact Name of the ethic committee：

Associate Prof. Wafaa Abd Ali Hattab, Ph.D

伦理委员会联系地址：

Al-Shaab, Al-Diwan, Street 40, Baghdad, Iraq

Contact Address of the ethic committee：

Al-Shaab, Al-Diwan, Street 40, Baghdad, Iraq

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +964 774 285 7710

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 nursing@conursing.uobaghdad.edu.iq

研究实施负责（组长）单位：

College of Nursing, University of Baghdad

Primary sponsor：

College of Nursing, University of Baghdad

研究实施负责（组长）单位地址：

Al-Shaab, Al-Diwan, Street 40, Baghdad, Iraq

Primary sponsor's address：

Al-Shaab, Al-Diwan, Street 40, Baghdad, Iraq

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

Iraq

省(直辖市)：

Baghdad

市(区县)：

Country：

Iraq

Province：

Baghdad

City：

单位(医院)：

University of Baghdad, College of Nursing

具体地址：

Bab Al muaadham, Baghdad, Street 729

Institution
hospital：

University of Baghdad, College of Nursing

Address：

Bab Al muaadham, Baghdad, Street 729

经费或物资来源：

Self-financed

Source(s) of funding：

Self-financed

研究疾病：

Dyspnea , Fatigue  

Target disease：

Dyspnea , Fatigue

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：

1. To evaluate the effectiveness of inspiratory muscle training on dyspnea among critically ill burn patients receiving high-flow nasal oxygen therapy (pre-post test). 2. To evaluate the effectiveness of inspiratory muscle training on fatigue among critically ill burn patients receiving high-flow nasal oxygen therapy (pre-post test). 3. To find out the relationship between effectiveness inspiratory muscle training and patients’ sociodemographic data.  

Objectives of Study：

1. To evaluate the effectiveness of inspiratory muscle training on dyspnea among critically ill burn patients receiving high-flow nasal oxygen therapy (pre-post test). 2. To evaluate the effectiveness of inspiratory muscle training on fatigue among critically ill burn patients receiving high-flow nasal oxygen therapy (pre-post test). 3. To find out the relationship between effectiveness inspiratory muscle training and patients’ sociodemographic data.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.18–65 years old adults; 2.Second- or third-degree burn with >=20% TBSA; 3.Stable and cooperative; 4.Under high-flow nasal oxygen therapy (HFNC); 5.Maximum Inspiratory Pressure (MIP) Ranges between 9 and 41 cmH2O.

Inclusion criteria

1.18–65 years old adults; 2.Second- or third-degree burn with >=20% TBSA; 3.Stable and cooperative; 4.Under high-flow nasal oxygen therapy (HFNC); 5.Maximum Inspiratory Pressure (MIP) Ranges between 9 and 41 cmH2O.

排除标准：

1.Unstable chronic cardiovascular or respiratory diseases. 2.Present acute respiratory infections. 3.Mental or physical incapability for performing IMT. 4.Receipt of other therapies having an effect upon the study outcomes. 5.Maximum Inspiratory Pressure (MIP) Ranges under 9_ above 41 cmH?O.

Exclusion criteria：

1.Unstable chronic cardiovascular or respiratory diseases. 2.Present acute respiratory infections. 3.Mental or physical incapability for performing IMT. 4.Receipt of other therapies having an effect upon the study outcomes. 5.Maximum Inspiratory Pressure (MIP) Ranges under 9_ above 41 cmH?O.

研究实施时间：

Study execute time：

从 From 2025-11-10 00:00:00至 To 2026-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-11-15 00:00:00 至 To 2026-01-05 00:00:00

干预措施：

Interventions：

组别：

Control group

样本量：

 29

Group：

Control group

Sample size：

干预措施：

Conventional care

干预措施代码：

Intervention：

Conventional care

Intervention code：

组别：

Intervention group

样本量：

 27

Group：

Intervention group

Sample size：

干预措施：

Conventional care and inspiratory muscle training intervention (The inspiratory muscle training protocol used in the present study was designed and implemented in accordance with evidence-based respiratory rehabilitation guidelines, including the recommendations of the American Thoracic Society and the European Respiratory Society for respiratory muscle training, as well as contemporary clinical practice guidelines for the respiratory management of critically ill and burn patients receiving high-flow nasal oxygen therapy.)

干预措施代码：

Intervention：

Conventional care and inspiratory muscle training intervention (The inspiratory muscle training protocol used in the present study was designed and implemented in accordance with evidence-based respiratory rehabilitation guidelines, including the recommendations of the American Thoracic Society and the European Respiratory Society for respiratory muscle training, as well as contemporary clinical practice guidelines for the respiratory management of critically ill and burn patients receiving high-flow nasal oxygen therapy.)

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 Iraq

省(直辖市)：

 Baghdad 

市(区县)：

  

Country：

Iraq

Province：

Baghdad

City：

单位(医院)：

 University of Baghdad, College of Nursing 

单位级别：

  

Institution
hospital：

University of Baghdad, College of Nursing

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

Dyspnea

指标类型：

主要指标

Outcome：

Dyspnea

Type：

Primary indicator

测量时间点：

one days and fourteen days after the intervention

测量方法：

Dyspnea_12 Questionnaire Scale

Measure time point of outcome：

one days and fourteen days after the intervention

Measure method：

Dyspnea_12 Questionnaire Scale

指标中文名：

Fatigue

指标类型：

主要指标

Outcome：

Fatigue

Type：

Primary indicator

测量时间点：

one days and fourteen days after the intervention

测量方法：

Fatigue Severity Scale

Measure time point of outcome：

one days and fourteen days after the intervention

Measure method：

Fatigue Severity Scale

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

N/A

组织：

Sample Name：

N/A

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：

结束

/Completed

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）：

Random selection and assignment Manual methods: based on the simple random sampling method in such a way that each member of the participants is given a number. The numbers are then placed in a drawing container. Finally, the numbers are selected, recorded, and returned to the container. (to replicate and control confounding variables)

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

Random selection and assignment Manual methods: based on the simple random sampling method in such a way that each member of the participants is given a number. The numbers are then placed in a drawing container. Finally, the numbers are selected, recorded, and returned to the container. (to replicate and control confounding variables)

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：

Non-blinding

Blinding：

Non-blinding

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

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）：

Contact the researcher by email

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

Contact the researcher by email

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：

Questionnaires and scales were used to collect data, and databases were used to manage data.

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

Questionnaires and scales were used to collect data, and databases were used to manage data.

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：

  2026-02-10 10:45:54