Early Evaluation After Cardiac Surgery

NCT ID: NCT05932368

Last Updated: 2023-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-10

Study Completion Date

2023-09-21

Brief Summary

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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

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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

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Open Heart Surgery

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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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.

evaluation

Intervention Type OTHER

examining files and taking records

Interventions

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evaluation

examining files and taking records

Intervention Type OTHER

Eligibility Criteria

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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%

* Who do not give the necessary permission to use their data
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Beykent

OTHER

Sponsor Role lead

Responsible Party

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Yasemin Şahbaz

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Prof. Dr. İpek Yeldan

Role: STUDY_CHAIR

Istanbul University - Cerrahpasa

Yasemin ŞAHBAZ

Role: PRINCIPAL_INVESTIGATOR

İstanbul Beykent Üniversitesi

Dr. Doğan Yetüt

Role: STUDY_CHAIR

Hakkari State Hospital, Cardiovascular Surgery, Hakkari

Pt. Tülin Özalhas

Role: STUDY_CHAIR

Istanbul University, Istanbul Faculty of Medicine, Department of Cardiovascular Surgery, Istanbul

Prof. Dr. İbrahim Ufuk Alpagut

Role: STUDY_CHAIR

Istanbul University, Istanbul Faculty of Medicine, Department of Cardiovascular Surgery, Istanbul

Locations

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Beykent University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 15994402 (View on PubMed)

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.

Reference Type RESULT
PMID: 12091180 (View on PubMed)

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.149.2.8306041.

Reference Type RESULT
PMID: 8306041 (View on PubMed)

Other Identifiers

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UBeykent-4

Identifier Type: -

Identifier Source: org_study_id

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