Early Evaluation After Cardiac Surgery

NCT05932368 | Completed

• 1 other identifier: UBeykent-4
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Open Heart Surgery

Keywords

open heart surgery; respiratory functions; cardiac surgery; respiratory muscle strength; functional capacity

Outcome Measures

Primary Outcomes (7)

• 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]

• 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]

• 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]

• 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]

• 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]

• 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]

• 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 Outcomes (1)

• Functional Capacity

  through study completion, an average of 1 months]

Study Arms (1)

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.

Other: evaluation

Interventions

evaluation OTHER

examining files and taking records

patients undergoing open heart surgery

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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%

You may not qualify if:

• Who do not give the necessary permission to use their data

Sponsors & Collaborators

• University of Beykent: lead

Study Sites (1)

Beykent University

Istanbul, 34500, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 15994402 RESULT

• 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.

  PMID: 12091180 RESULT

• 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.

  PMID: 8306041 RESULT

Study Officials

• Prof. Dr. İpek Yeldan

  Istanbul University - Cerrahpasa

  STUDY CHAIR

• Yasemin ŞAHBAZ

  İstanbul Beykent Üniversitesi

  PRINCIPAL INVESTIGATOR

• Dr. Doğan Yetüt

  Hakkari State Hospital, Cardiovascular Surgery, Hakkari

  STUDY CHAIR

• Pt. Tülin Özalhas

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

  STUDY CHAIR

• Prof. Dr. İbrahim Ufuk Alpagut

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 10 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: July 6, 2023
• Study Start: August 10, 2023
• Primary Completion: September 20, 2023
• Study Completion: September 21, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)