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Recruiting NCT06997224

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

No phase Interventional Mitral Valve Failure Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: triflow application.
Who it may be relevant to
Registry conditions: Mitral Valve Failure, Surgery. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Other 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.

Primary outcome measures

  • The Visual Analog Scale (VAS) [Time frame: perioperative 1 hour]
  • The Visual Analog Scale (VAS) [Time frame: postoperative evening]
  • Postoperative Patient Follow-Up and Evaluation Form [Time frame: postoperative evening]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Turkey (Türkiye) · 2 centers
  • Medipol Hospital — Istanbul
  • Medipol Hospital — Istanbul

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. PMID 41668083

Identifiers

NCT: NCT06997224 · 2024-11

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗