Assessment in Patients After Thoracic Surgery
2017年9月27日 更新者：Marie Carmen Valenza、Universidad de Granada
Evaluation of Hospitalized Patients After Thoracic Pulmonary Resection Surgery
Lung cancer is the leading cause of death in men and the second in women with a 5 year survival in Europe of less than 15%.
One of the methods most used for its treatment is pulmonary resection.
The objective of this study is to analyze the clinical profile presented to patients after pulmonary resection.
研究概览
地位
未知
条件
详细说明
One of the most widely used methods for the treatment of lung cancer is pulmonary resection.
The morbidity and mortality of pulmonary resection surgery is conditioned by both the type of intervention and the patient's condition.
Functional deterioration is a risk associated with hospitalization in the elderly, with a high prevalence (35-70%) and serious consequences, since in the majority it can lead to the appearance of complications not related to the reason for admission or the specific treatment.
It is very important to evaluate the clinical profile of patients after pulmonary resection in order to stablish a more specific repercussion.
研究类型
观察性的
注册 (预期的)
40
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Granada、西班牙、18071
- 招聘中
- Department of Physical Therapy
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Men and / or women of legal age who are admitted for lung resection, with the approval of the physician responsible, and who sign the informed consent
描述
Inclusion Criteria:
- Patient admitted for lung resection and who sign the informed consent
Exclusion Criteria:
- Patients who did not agree to sign informed consent and those who presented other types of problems to be able to adequately carry out the assessment, such as not handling the language.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Strength in upper and lower limbs
大体时间：Baseline, up to 1 month
|
Changes from baseline to postintervention during hospital stay in lower and upper limbs strength.
The quadriceps and the hand-grip strength is assessed using a portable dynamometer with a standard protocol allowing three attempts on each side.
|
Baseline, up to 1 month
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Exercise capacity
大体时间：Baseline, up to 1 month
|
Five times sit to stand test (5STS) will be used to assess exercise capacity.
5STS is a simple assessment tool that is feasible in all healthcare settings and involves asking the patient to stand up 5 times for the shortest possible time without arm support.. Saturation and heart rate will be monitored as well as levels of dyspnea and fatigue of the patient.
|
Baseline, up to 1 month
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
合并症
大体时间：基线
|
查尔森合并症指数将用于评估患者的合并症，它是一种简单有效的估计合并症死亡风险的方法。
它包含 19 类合并症，并预测可能患有一系列合并症的患者的十年死亡率。
根据与这种情况相关的死亡风险，每种情况都被分配了 1、2、3 或 6 分。
|
基线
|
|
Mood
大体时间：Baseline, up to 1 month
|
Mood in these patients will be measured by the Hospital Anxiety and Depression Scale.
|
Baseline, up to 1 month
|
|
Fatigue
大体时间：Baseline, up to 1 month
|
Fatigue will be assessed with the Fatigue Severity Scale (FSS).
The FSS is a nine-item instrument designed to assess fatigue as a symptom of a variety of different chronic conditions and disorders.
The scale addresses fatigue's effects on daily functioning, and its relation to motivation, physical activity, work, family, and social life, and the answers to the problem with which they are fatigued and the degree to which the problem poses a problem for them .
|
Baseline, up to 1 month
|
|
Changes in quality of sleep
大体时间：Baseline, up to 1 month
|
changes in quality of sleep from baseline to postintervention.
For this purpose, the participants are going to complete the Pittsburgh Quality of Sleep Index.
This is a self-rating questionnaire with seven subscores that result in a global score between 0 and 21.
|
Baseline, up to 1 month
|
|
Nutritional status
大体时间：Baseline, up to 1 month
|
Nutritional status was evaluated with Mini nutritional assessment (MNA) test, that is validated to provide a single, rapid assessment of nutritional status in elderly patients in outpatient clinics, hospitals, and nursing homes.
The MNA test is composed of simple measurements and brief questions that can be completed in about 10 min.
|
Baseline, up to 1 month
|
|
Dyspnoea
大体时间：PBaseline, up to 1 month
|
Changes from baseline to postintervention in dyspnoea measured with Borg Scale
|
PBaseline, up to 1 month
|
|
Dependence
大体时间：Baseline, up to 1 month
|
The Barthel Index determines the degree of dependence of the patient for performing the basic activities of daily living.
It is a questionnaire that consists of 10 items, and at lower score, more dependency; and higher score, more independence.
|
Baseline, up to 1 month
|
|
Pain
大体时间：Baseline, up to 1 month
|
Pain will be assessed by using the Visual Analogue Scale
|
Baseline, up to 1 month
|
|
Cough
大体时间：Baseline, up to 1 month
|
The cough will be assessed with the Leicester cough questionnaire that objectively assesses chronic cough and its effect on quality of life.
It is structured in three domains: physical, psychological and social.
|
Baseline, up to 1 month
|
|
Pain
大体时间：Baseline, up to 1 month
|
Pain will be assessed by using a brief pain-specific questionnaire, Brief Pain Inventory, too.
|
Baseline, up to 1 month
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Marie Carmen Valenza, PT, PhD、Universidad de Granada
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年9月1日
初级完成 (预期的)
2018年6月1日
研究完成 (预期的)
2018年7月1日
研究注册日期
首次提交
2017年9月20日
首先提交符合 QC 标准的
2017年9月27日
首次发布 (实际的)
2017年10月3日
研究记录更新
最后更新发布 (实际的)
2017年10月3日
上次提交的符合 QC 标准的更新
2017年9月27日
最后验证
2017年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
胸外科的临床试验
-
Istanbul University尚未招聘