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

NCT06997224 | Recruiting

• 1 other identifier: 2024-11
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Mitral Valve Failure; Surgery

Keywords

triflow; respiratory functions; cough exercise

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  postoperative evening

Study Arms (2)

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.

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.

Interventions

triflow application 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.

triflow group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Atlas University: lead

Study Sites (2)

Medipol Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Medipol Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Central Study Contacts

çağla toprak, dr

CONTACT

532 799 78 14; caykinn@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 30, 2025
• Study Start: May 15, 2025
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)