Open Heart Surgery Clinical Trial
Official title:
Investigation of Early Change and Relationship Between Respiratory Functions, Respiratory Muscle Strength and Functional Capacities of Patients Undergoing Open Heart Surgery
Verified date | September 2023 |
Source | University of Beykent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
The aim of this study is to examine the changes in respiratory function, respiratory muscle strength and functional capacity markers and the relationship between them in patients who have undergone open heart surgery and are at the discharge stage. Method: Preoperative and postoperative evaluation results of 34 patients at discharge will be examined. Evaluations in the file; demographic data, respiratory functions; It will include spirometric measurements and intraoral pressure measurements and functional capacity measurement results. SPSS version 25 will be used in data analysis. The distribution of the participants according to their gender among the groups, presence of chronic diseases, regular drug use, smoking, alcohol use, regular exercise habits will be evaluated with the "chi-square" test. The conformity of the data to the normal distribution will be tested with the Shaphiro-Wilk Test. The difference between before and after the operation will be evaluated with the Paired Sample T Test. Pearson Correlation Test was performed for the relationship between independent variables and the significance level will be accepted as p<0.05.
Status | Completed |
Enrollment | 34 |
Est. completion date | September 21, 2023 |
Est. primary completion date | September 20, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 25 Years to 70 Years |
Eligibility | Inclusion Criteria: - The patient is between the ages of 25-70 - Having had open heart surgery - Being enrolled in a phase 1 cardiac rehabilitation program - Preoperative ejection fraction above 40% Exclusion Criteria: - Not meeting the inclusion criteria - Who do not give the necessary permission to use their data |
Country | Name | City | State |
---|---|---|---|
Turkey | Beykent University | Istanbul |
Lead Sponsor | Collaborator |
---|---|
University of Beykent |
Turkey,
ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Errat — View Citation
Enright PL, Kronmal RA, Manolio TA, Schenker MB, Hyatt RE. Respiratory muscle strength in the elderly. Correlates and reference values. Cardiovascular Health Study Research Group. Am J Respir Crit Care Med. 1994 Feb;149(2 Pt 1):430-8. doi: 10.1164/ajrccm. — View Citation
Miller MR, Crapo R, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. General cons — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Spirometric Measurements-Forced vital capacity (FVC) | FVC value, which was evaluated according to the ATS/ERS (American Thoracic Society/European Respiratory Society) criteria, where the highest results were recorded as a result of the measurements repeated 3 times in the PFT test, will be drawn from the patient files. | through study completion, an average of 1 months] | |
Primary | Spirometric Measurements-Forced expiratory volume (FEV1) | Forced expiratory volume (FEV1) calculates the amount of air that a person can force out of their lungs in 1 second.
FEV1 value, which was evaluated according to the ATS/ERS (American Thoracic Society/European Respiratory Society) criteria, where the highest results were recorded as a result of the measurements repeated 3 times in the PFT test, will be drawn from the patient files. |
through study completion, an average of 1 months] | |
Primary | Spirometric Measurements-FEF25-75 | FEF25-75 is the most sensitive measure of airflow in peripheral airways where primary airflow obstruction originates,7 and it is reduced in early bronchial impairment, which is associated with small airway disease.
FEF25-75 value, which was evaluated according to the ATS/ERS (American Thoracic Society/European Respiratory Society) criteria, where the highest results were recorded as a result of the measurements repeated 3 times in the PFT test, will be drawn from the patient files. |
through study completion, an average of 1 months] | |
Primary | Spirometric Measurements-MVV | Formerly referred to as maximum breathing capacity, maximum voluntary ventilation (MVV) is a pulmonary function test (PFT) that measures the maximum amount of air a person can inhale and then exhale with voluntary effort
MVV value, which was evaluated according to the ATS/ERS (American Thoracic Society/European Respiratory Society) criteria, where the highest results were recorded as a result of the measurements repeated 3 times in the PFT test, will be drawn from the patient files. |
through study completion, an average of 1 months] | |
Primary | Spirometric Measurements--Peak Expiratory Flow (PEF) | PEF value, which was evaluated according to the ATS/ERS (American Thoracic Society/European Respiratory Society) criteria, where the highest results were recorded as a result of the measurements repeated 3 times in the PFT test, will be drawn from the patient files. | through study completion, an average of 1 months] | |
Primary | Intraoral Pressure Measurement-MIP | Maximum inspiratory pressure (MIP) value evaluated according to ATS/ERS criteria, where the highest results are recorded as a result of measurements repeated 3 times in the respiratory muscle strength test, will be drawn from the patient files. While interpreting the results, the normal values of inspiratory determined by age and gender were taken and the percentage of the expected value will be used. | through study completion, an average of 1 months] | |
Primary | Intraoral Pressure Measurement-MEP | Maximum expiratory pressure (MEP) value evaluated according to ATS/ERS criteria, where the highest results are recorded as a result of measurements repeated 3 times in the respiratory muscle strength test, will be drawn from the patient files. While interpreting the results, the normal values of expiratory muscle strength determined by age and gender were taken and the percentage of the expected value will be used. | through study completion, an average of 1 months] | |
Secondary | Functional Capacity | 6-minute walk test (6MWT) Information about the test, which is applied in a 30-meter (m) long hospital corridor and the 6-minute walking distance of the patients is recorded, will be drawn from the patient file (ATS, 2016). | through study completion, an average of 1 months] |
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