Customizable respiratory exercise device for patients after cardiac surgery
Examining the Clinical Efficiency of a Customizable Respiratory Exercise Device in Individuals Who Have Undergone Cardiac Surgery
This study tests a special breathing exercise device to see if it helps people recover better after heart surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | All |
| Sponsor | Biruni University Academic / other |
| Locations | 1 site (Istanbul, Istanbul) |
| Trial ID | NCT06258681 on ClinicalTrials.gov |
What this trial studies
This study evaluates a customizable respiratory exercise device designed for individuals who have undergone cardiac surgery, specifically targeting those with coronary artery disease. The device aims to enhance respiratory muscle training through individualized breathing exercises, which can improve respiratory function and reduce postoperative complications. Participants will engage in respiratory training using an incentive spirometer and receive visual feedback to optimize their exercises. The study focuses on patients scheduled for elective surgeries such as coronary artery bypass grafting and valve replacements.
Who should consider this trial
Good fit: Ideal candidates include individuals with New York Heart Association Functional Class I or II scheduled for elective cardiac surgeries.
Not a fit: Patients with uncontrolled arrhythmias, chronic respiratory diseases, or significant orthopedic limitations may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly improve respiratory function and recovery outcomes for patients after cardiac surgery.
How similar studies have performed: Previous studies have shown positive outcomes with respiratory muscle training in cardiac rehabilitation, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * Individuals with New York Heart Association Functional Class I or II who are scheduled to undergo elective coronary artery bypass graft surgery, aortic valve replacement, mitral valve replacement, or combined surgery of aortic and mitral valve replacement * Individuals who are planning to undergo surgery with the median sternotomy technique * Individuals with Mini-Mental State Score \>24 Exclusion criteria * Individuals with uncontrolled arrhythmia, unstable angina pectoris, uncontrolled hypertension * Individuals with accompanying chronic respiratory disease * Individuals with accompanying neuromuscular or orthopedic/musculoskeletal limitations * Individuals with a history of spontaneous or trauma-related pneumothorax * Individuals with middle ear-related pathologies (such as tympanic membrane rupture otitis) * Cases with thorax drains in the ward * Individuals who stayed in the intensive care unit for ≥ 4 days in the postoperative period * Individuals who have had another surgery in the last six months
Where this trial is running
Istanbul, Istanbul
- Istanbul Florence Nightingale Hospital — Istanbul, Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Buket Akinci, Assoc. Prof.
- Email: bakinci@biruni.edu.tr
- Phone: +90 212 444 8 276
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.