Mitral Valve FailureNCT06997224
Effects of Triflow and Deep Breathing and Cough Exercises on Respiration in Patients Undergoing Mitral Valve Replacement
A study testing triflow application in people with Mitral Valve Failure and Surgery, run by Atlas University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mitral Valve Failure, Surgery
- What is being tested?
- triflow application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 May 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteering to participate in the study Literate and knowing the native language
Who cannot join
- Hemodynamically unstable patients, Patients who develop postoperative respiratory complications, Lip or palate anomalies
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Medipol Hospital
Istanbul
naile akıncı
- Recruiting
Medipol Hospital
Istanbul
naile akıncı, dr
About this study
Official title: Comparison of the Effects of Triflow and Deep Breathing and Cough Exercises on Postoperative Respiratory Functions in Patients Undergoing Mitral Valve Replacement: A Randomized Controlled Trial
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.
Read the 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
- Being tested
- triflow application
- Keywords
- triflow, respiratory functions, cough exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triflow applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| triflow group | Experimental | 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. Receives: Other: triflow application |
| control group | No intervention | After the surgery, patients will not be taught cough breathing exercises. Only the triflo application will be performed. The process will continue until discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Visual Analog Scale (VAS)
VAS is a one-dimensional scale used to measure subjective parameters. It consists of a 10-cm- long line drawn vertically or horizontally. At either end of this line are the two extreme descriptive words of the subjective category (0 = "no pain at all", 10 = worst/unbearable pain"). The patient is asked to indicate the point which matches his/her situation by placing a dot or drawing a line on this 10-cm-long line. It has been widely accepted in the world literature as a valid and reliable measurement tool in the evaluation of postoperative acute pain intensity.
Measured: perioperative 1 hour
The Visual Analog Scale (VAS)
VAS is a one-dimensional scale used to measure subjective parameters. It consists of a 10-cm- long line drawn vertically or horizontally. At either end of this line are the two extreme descriptive words of the subjective category (0 = "no pain at all", 10 = worst/unbearable pain"). The patient is asked to indicate the point which matches his/her situation by placing a dot or drawing a line on this 10-cm-long line. It has been widely accepted in the world literature as a valid and reliable measurement tool in the evaluation of postoperative acute pain intensity.
Measured: postoperative evening
Postoperative Patient Follow-Up and Evaluation Form
It was created by researchers to evaluate cardiovascular and respiratory parameters, time to first mobilization, pain and complications.
Measured: postoperative evening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start15 May 2025
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagla Toprak, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997224
- Sponsor's protocol ID
- 2024-11
- Status last verified
- May 2025
- First submitted
- 15 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akinci N, Eren E. Effects of combined Triflow, deep breathing and coughing exercises on postoperative pulmonary function after mitral valve replacement: a randomized controlled trial. BMC Surg. 2026 Feb 10;26(1):164. doi: 10.1186/s12893-026-03542-7.
PubMed 41668083
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Triflow and Deep Breathing and Cough Exercises on Postoperative Respiratory Functions in Patients Undergoing Mitral Valve Replacement: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06997224
- Acronym / sponsor ID
- 2024-11
- Conditions
- Mitral Valve Failure, Surgery
- Keywords
- triflow, respiratory functions, cough exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 30 May 2025 (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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| triflow group | Experimental | Other: triflow applicationBefore 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. |
| control group | No intervention | –After the surgery, patients will not be taught cough breathing exercises. Only the triflo application will be performed. The process will continue until discharge. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Volunteering to participate in the study Literate and knowing the native language
Key exclusion criteria (1 listed)
- Hemodynamically unstable patients, Patients who develop postoperative respiratory complications, Lip or palate anomalies
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 |
|---|---|---|
| triflow applicationAfter 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. | Other | triflow group |
Primary outcome
The Visual Analog Scale (VAS)
Time frame: perioperative 1 hour
VAS is a one-dimensional scale used to measure subjective parameters. It consists of a 10-cm- long line drawn vertically or horizontally. At either end of this line are the two extreme descriptive words of the subjective category (0 = "no pain at all", 10 = worst/unbearable pain"). The patient is asked to indicate the point which matches his/her situation by placing a dot or drawing a line on this 10-cm-long line. It has been widely accepted in the world literature as a valid and reliable measurement tool in the evaluation of postoperative acute pain intensity.
The Visual Analog Scale (VAS)
Time frame: postoperative evening
VAS is a one-dimensional scale used to measure subjective parameters. It consists of a 10-cm- long line drawn vertically or horizontally. At either end of this line are the two extreme descriptive words of the subjective category (0 = "no pain at all", 10 = worst/unbearable pain"). The patient is asked to indicate the point which matches his/her situation by placing a dot or drawing a line on this 10-cm-long line. It has been widely accepted in the world literature as a valid and reliable measurement tool in the evaluation of postoperative acute pain intensity.
Postoperative Patient Follow-Up and Evaluation Form
Time frame: postoperative evening
It was created by researchers to evaluate cardiovascular and respiratory parameters, time to first mobilization, pain and complications.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Derived from this study: PubMed 41668083Akinci N, Eren E. Effects of combined Triflow, deep breathing and coughing exercises on postoperative pulmonary function after mitral valve replacement: a randomized controlled trial. BMC Surg. 2026 Feb 10;26(1):164. doi: 10.1186/s12893-026-03542-7.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing triflow application in people with Mitral Valve Failure and Surgery, run by Atlas University at 2 sites 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact çağla toprak, dr (532 799 78 14, caykinn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Visual Analog Scale (VAS) (time frame: perioperative 1 hour). The study lists 3 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 NCT06997224, which also lists 1 linked publication.
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 30 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.