- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03300622
Assessment in Patients After Thoracic Surgery
September 27, 2017 updated by: 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.
Study Overview
Status
Unknown
Conditions
Detailed Description
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.
Study Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Granada, Spain, 18071
- Recruiting
- Department of Physical Therapy
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
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
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Strength in upper and lower limbs
Time Frame: 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.
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Baseline, up to 1 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exercise capacity
Time Frame: 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.
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Baseline, up to 1 month
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comorbidities
Time Frame: Baseline
|
Charlson Comorbidity Index will be used to assess the comorbidities of the patients, it is a simple and valid method of estimating risk of death from comorbid disease.
It contains 19 categories of comorbidity and predicts the ten-year mortality for a patient who may have a range of co-morbid conditions.
Each condition is assigned with a score of 1, 2, 3 or 6 depending on the risk of dying associated with this condition.
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Baseline
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Mood
Time Frame: Baseline, up to 1 month
|
Mood in these patients will be measured by the Hospital Anxiety and Depression Scale.
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Baseline, up to 1 month
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Fatigue
Time Frame: 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 .
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Baseline, up to 1 month
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Changes in quality of sleep
Time Frame: Baseline, up to 1 month
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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.
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Baseline, up to 1 month
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Nutritional status
Time Frame: Baseline, up to 1 month
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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
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Dyspnoea
Time Frame: PBaseline, up to 1 month
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Changes from baseline to postintervention in dyspnoea measured with Borg Scale
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PBaseline, up to 1 month
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Dependence
Time Frame: 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.
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Baseline, up to 1 month
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Pain
Time Frame: Baseline, up to 1 month
|
Pain will be assessed by using the Visual Analogue Scale
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Baseline, up to 1 month
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Cough
Time Frame: Baseline, up to 1 month
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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.
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Baseline, up to 1 month
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Pain
Time Frame: Baseline, up to 1 month
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Pain will be assessed by using a brief pain-specific questionnaire, Brief Pain Inventory, too.
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Baseline, up to 1 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marie Carmen Valenza, PT, PhD, Universidad de Granada
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2017
Primary Completion (Anticipated)
June 1, 2018
Study Completion (Anticipated)
July 1, 2018
Study Registration Dates
First Submitted
September 20, 2017
First Submitted That Met QC Criteria
September 27, 2017
First Posted (Actual)
October 3, 2017
Study Record Updates
Last Update Posted (Actual)
October 3, 2017
Last Update Submitted That Met QC Criteria
September 27, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DF0070UG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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