Open Heart SurgeryNCT05932368
Early Evaluation After Cardiac Surgery
An observational study of Open Heart Surgery, run by University of Beykent at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Open Heart Surgery
- What is being tested?
- evaluation
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Aug 2023to 21 Sep 2023
- How long will I take part?
- 10 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- Adult, Older adult
Study population: Patients who underwent open heart surgery at Istanbul University, Istanbul Faculty of Medicine, Department of Cardiovascular Surgery, and whose data required for the study are complete in their discharge file, will be selected from among the files. Patient data from 2018 to 2022 will be reviewed, and patients who have consented to use their data for the study will be included in the study. Evaluation data of the patients before the operation and at the discharge stage after the operation will be drawn from the patient files.
Who may be able to join
- 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%
Who cannot join
- Not meeting the inclusion criteria
- Who do not give the necessary permission to use their data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Early Change and Relationship Between Respiratory Functions, Respiratory Muscle Strength and Functional Capacities of Patients Undergoing Open Heart Surgery
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.
Read more
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.
Read the detailed description
The patient data analyzed for this retrospective study will be selected from the files of patients who underwent open heart surgery at Istanbul University, Istanbul Medical Faculty, Department of Cardiovascular Surgery and whose data required for the study were complete in their discharge file. Patient data between 2018 and 2022 will be reviewed and patients who consented to use their data for the study will be included in the study. Evaluation data of the patients before the operation and at the discharge stage after the operation will be drawn from the patient files. The study will be prepared in accordance with the Helsinki Declaration Criteria. Before starting the study, ethics committee approval was obtained from Istanbul University Istanbul Medical Faculty Clinical Research Ethics Committee (permission no: 1208327; date: 15/09/2022). All patients were informed verbally/written about the study and their written consents will be obtained.
The inclusion criteria of the files in the study will be determined as the patient's age between 25-70 years, having undergone open heart surgery, being included in a phase 1 cardiac rehabilitation program, and having an ejection fraction above 40% before the operation. Files of patients who do not meet the inclusion criteria and do not give the necessary permission to use their data will not be included in the study. Spirometric Measurements FVC, FEVı, FEVı%, PEF, FEF25-75 and MVV values, which were 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.
Intraoral Pressure Measurement Maximum inspiratory pressure (MIP), maximum expiratory pressure (MEP) values 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 and expiratory muscle strength determined by age and gender will be taken and the percentage of the expected value will be used.
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.
- Conditions
- Open Heart Surgery
- Being tested
- evaluation
- Keywords
- open heart surgery, respiratory functions, cardiac surgery, respiratory muscle strength, functional capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluationOther
examining files and taking records
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing open heart surgery | Patients who underwent open heart surgery at Istanbul University, Istanbul Medical Faculty, Department of Cardiovascular Surgery between 2018 and 2022, and whose data required for the study are complete in their discharge file.
The inclusion criteria of the files were: the patient was between the ages of 25-70, had undergone open heart surgery, was included in a phase 1 cardiac rehabilitation program, and had a preoperative ejection fraction of over 40%. Files of patients who do not meet the inclusion criteria and do not give the necessary permission to use their data will not be included in the study. Receives: Other: evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 months]
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.
Measured: through study completion, an average of 1 months]
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.
Measured: through study completion, an average of 1 months]
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.
Measured: through study completion, an average of 1 months]
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.
Measured: through study completion, an average of 1 months]
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.
Measured: through study completion, an average of 1 months]
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.
Measured: through study completion, an average of 1 months]
Secondary outcomes (1)
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).
Measured: through study completion, an average of 1 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start10 Aug 2023
- Primary completion20 Sep 2023
- Study completion21 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Open Heart SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 34 participants (actual)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Şahbaz, University of Beykent
- Investigators
- Prof. Dr. İpek Yeldan, Study chair, Istanbul University - CerrahpasaYasemin ŞAHBAZ, Principal investigator, İstanbul Beykent ÜniversitesiDr. Doğan Yetüt, Study chair, Hakkari State Hospital, Cardiovascular Surgery, HakkariPt. Tülin Özalhas, Study chair, Istanbul University, Istanbul Faculty of Medicine, Department of Cardiovascular Surgery, IstanbulProf. Dr. İbrahim Ufuk Alpagut, Study chair, Istanbul University, Istanbul Faculty of Medicine, Department of Cardiovascular Surgery, Istanbul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932368
- Sponsor's protocol ID
- UBeykent-4
- Status last verified
- Sep 2023
- First submitted
- 20 Jun 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 considerations for lung function testing. Eur Respir J. 2005 Jul;26(1):153-61. doi: 10.1183/09031936.05.00034505. No abstract available.
PubMed 15994402ATS 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.
PubMed 12091180Enright 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.149.2.8306041.
PubMed 8306041Sahbaz Y, Yeldan I, Ozalhas T, Yetut D, Alpagut IU. Effects and relationships of early physiotherapy on respiratory functions and functional capacity at discharge in patients undergoing open heart surgery. BMC Cardiovasc Disord. 2026 Mar 4;26(1):306. doi: 10.1186/s12872-026-05674-3.
PubMed 41782082
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Early Change and Relationship Between Respiratory Functions, Respiratory Muscle Strength and Functional Capacities of Patients Undergoing Open Heart Surgery
- ClinicalTrials.gov ID
- NCT05932368
- Acronym / sponsor ID
- UBeykent-4
- Conditions
- Open Heart Surgery
- Keywords
- open heart surgery, respiratory functions, cardiac surgery, respiratory muscle strength, functional capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The patient data analyzed for this retrospective study will be selected from the files of patients who underwent open heart surgery at Istanbul University, Istanbul Medical Faculty, Department of Cardiovascular Surgery and whose data required for the study were complete in their discharge file. Patient data between 2018 and 2022 will be reviewed and patients who consented to use their data for the study will be included in the study. Evaluation data of the patients before the operation and at the discharge stage after the operation will be drawn from the patient files. The study will be prepared in accordance with the Helsinki Declaration Criteria. Before starting the study, ethics committee approval was obtained from Istanbul University Istanbul Medical Faculty Clinical Research Ethics Committee (permission no: 1208327; date: 15/09/2022). All patients were informed verbally/written about the study and their written consents will be obtained.
The inclusion criteria of the files in the study will be determined as the patient's age between 25-70 years, having undergone open heart surgery, being included in a phase 1 cardiac rehabilitation program, and having an ejection fraction above 40% before the operation. Files of patients who do not meet the inclusion criteria and do not give the necessary permission to use their data will not be included in the study. Spirometric Measurements FVC, FEVı, FEVı%, PEF, FEF25-75 and MVV values, which were 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.
Intraoral Pressure Measurement Maximum inspiratory pressure (MIP), maximum expiratory pressure (MEP) values 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 and expiratory muscle strength determined by age and gender will be taken and the percentage of the expected value will be used.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 10 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergoing open heart surgery | – | Other: evaluationPatients who underwent open heart surgery at Istanbul University, Istanbul Medical Faculty, Department of Cardiovascular Surgery between 2018 and 2022, and whose data required for the study are complete in their discharge file. The inclusion criteria of the files were: the patient was between the ages of 25-70, had undergone open heart surgery, was included in a phase 1 cardiac rehabilitation program, and had a preoperative ejection fraction of over 40%. Files of patients who do not meet the inclusion criteria and do not give the necessary permission to use their data will not be included in the study. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent open heart surgery at Istanbul University, Istanbul Faculty of Medicine, Department of Cardiovascular Surgery, and whose data required for the study are complete in their discharge file, will be selected from among the files. Patient data from 2018 to 2022 will be reviewed, and patients who have consented to use their data for the study will be included in the study. Evaluation data of the patients before the operation and at the discharge stage after the operation will be drawn from the patient files.
Key inclusion criteria (4 listed)
- 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%
Key exclusion criteria (2 listed)
- Not meeting the inclusion criteria
- Who do not give the necessary permission to use their data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evaluationexamining files and taking records | Other | patients undergoing open heart surgery |
Primary outcome
Spirometric Measurements-Forced vital capacity (FVC)
Time frame: through study completion, an average of 1 months]
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.
Spirometric Measurements-Forced expiratory volume (FEV1)
Time frame: through study completion, an average of 1 months]
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.
Spirometric Measurements-FEF25-75
Time frame: through study completion, an average of 1 months]
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.
Spirometric Measurements-MVV
Time frame: through study completion, an average of 1 months]
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.
Spirometric Measurements--Peak Expiratory Flow (PEF)
Time frame: through study completion, an average of 1 months]
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.
Intraoral Pressure Measurement-MIP
Time frame: through study completion, an average of 1 months]
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.
Intraoral Pressure Measurement-MEP
Time frame: through study completion, an average of 1 months]
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.
1 secondary outcome
Functional Capacity
Time frame: through study completion, an average of 1 months]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Results publication: PubMed 15994402Miller 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 considerations for lung function testing. Eur Respir J. 2005 Jul;26(1):153-61. doi: 10.1183/09031936.05.00034505. No abstract available.
- Results publication: PubMed 12091180ATS 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.
- Results publication: PubMed 8306041Enright 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.149.2.8306041.
- Derived from this study: PubMed 41782082Sahbaz Y, Yeldan I, Ozalhas T, Yetut D, Alpagut IU. Effects and relationships of early physiotherapy on respiratory functions and functional capacity at discharge in patients undergoing open heart surgery. BMC Cardiovasc Disord. 2026 Mar 4;26(1):306. doi: 10.1186/s12872-026-05674-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Dr. İpek Yeldan study chair
Istanbul University - Cerrahpasa
Yasemin ŞAHBAZ principal investigator
İstanbul Beykent Üniversitesi
Dr. Doğan Yetüt study chair
Hakkari State Hospital, Cardiovascular Surgery, Hakkari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open Heart Surgery, run by University of Beykent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spirometric Measurements-Forced vital capacity (FVC) (time frame: through study completion, an average of 1 months]). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05932368, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.