Effects of Triflow and Deep Breathing and Cough Exercises on Respiration in Patients Undergoing Mitral Valve Replacement

NCT ID: NCT06997224

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-15
• Study Completion Date: 2025-08-01

Brief Summary

The purpose of breathing exercises or the use of assistive devices is to provide deep breathing after surgery and to obtain a normal breathing pattern. The purpose of choosing the method to be applied is to obtain the best result. The results of the few studies conducted on this subject are contradictory and insufficient. In this context, the purpose of this study is to compare the effects of using only triflow and using triflow together with deep breathing and cough exercises on postoperative respiratory functions in patients who underwent simultaneous tricuspid valve surgery for mitral valve.

Detailed Description

Mitral valve disease is one of the most common causes of heart failure and death. Although heart valve diseases are not as common as heart failure, coronary artery disease or hypertension in developed countries, they are important because they are common and usually require intervention. In addition, rheumatic valve diseases are still an important public health problem in developing countries, and they mostly affect young patients. Since mitral valve diseases can progress without symptoms for a long time, when they are noticed, the damage to the valve may have reached a moderate or severe level. Therefore, it is necessary to carefully decide whether medical or surgical treatment is appropriate. The most common complications after mitral valve replacement are bleeding due to anticoagulant use, thromboembolism and deterioration in the valve structure, and some complications can be seen after surgery. The most common complications encountered are lung complications. The visibility of lung complications usually varies between 8-79%. The aim of this study is to compare the effects of using Triflow alone and using Triflow with deep breathing and cough exercises on postoperative respiratory functions in patients undergoing coronary artery bypass surgery.

Conditions

Mitral Valve Failure; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

triflow group

Before the operation, the experimental group will be taught the use of triflow and cough breathing exercises. On the first day after the operation, patients will be given triflow application 10 times every hour they are awake and cough and breathing exercises at other hours. Forms will be filled in before the application. After the application is completed at the end of the day, the forms will be filled in again. The application will continue until the patient is discharged.

Group Type: EXPERIMENTAL

triflow application

Intervention Type: OTHER

After we have exhaled, we will try to hold the balls up as long as possible by pulling them inward with all our strength. After repeating this five times, we will turn them over.

control group

After the surgery, patients will not be taught cough breathing exercises. Only the triflo application will be performed. The process will continue until discharge.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

triflow application

After we have exhaled, we will try to hold the balls up as long as possible by pulling them inward with all our strength. After repeating this five times, we will turn them over.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Volunteering to participate in the study Literate and knowing the native language

Exclusion Criteria

• Hemodynamically unstable patients, Patients who develop postoperative respiratory complications, Lip or palate anomalies

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atlas University

OTHER

Sponsor Role: lead

Responsible Party

Cagla Toprak

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medipol Hospital

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Medipol Hospital

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

çağla toprak, dr

Role: CONTACT

caykinn@gmail.com

532 799 78 14

Facility Contacts

naile akıncı

Role: primary

Other Identifiers

2024-11

Identifier Type: -

Identifier Source: org_study_id