Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03636633
Other study ID # ATADEK-2018-2/55
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 21, 2018
Est. completion date February 21, 2021

Study information

Verified date April 2022
Source Acibadem University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

During the past decade, especially with the advancement of technology, major innovations and developments have been observed in the field of surgery. Cardiac surgery is one of the important area of the surgery who renews itself day by day and adds innovations to the nature in terms of patients' comfort. One of the greatest developments in cardiac surgery in this sense is the tendency to reduce the size of the incisions with less interventional procedures. Robotic surgery is getting more and more meaningful in this area. Despite the downsizing of the surgical incisions, postoperative pulmonary complications have not completely disappeared in the robotic cardiac surgery. Major respiratory problems following traditional cardiac surgery are gas exchange problems, atelectasis, decreased coughing force and sputum retention. The effectiveness of respiratory physiotherapy applied after traditional cardiac surgery for the resolution of these complications has been proved by various investigations. Inspiratory muscle training (IMT) has been found to improve autonomic modulation in heart failure patients as well as to increase inspiratory muscle strength in applied patient populations, reduce blood pressure in hypertensive patients, and increase functional capacity in elderly individuals. Considering these benefits, when inspiratory muscle training is given to people with traditional cardiac surgery, respiratory muscle strengths, respiratory functions and functional capacities are increased compared to those not given to these patients. However, although there are complications after robotic cardiac surgery, there are no studies in the literature about respiratory physiotherapy or inspiratory muscle training. Thus, the subject of this study is the comparison of the effects of standard respiratory physiotherapy and standard respiratory physiotherapy plus inspiratory muscle training on the respiratory functions, respiratory muscle strength and functional capacity of the patients with the robotic heart surgery.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date February 21, 2021
Est. primary completion date March 21, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Being suitable for robotic cardiac surgery, - Being hospitalized to have a robotic heart surgery, - No complications during surgery, - To be extubated in intensive care unite after surgery , - Stable clinical condition, - To be transferred from ICU to the hospital room on the first day after surgery. Exclusion Criteria: - Chronic obstructive pulmonary disease, - Unstable angina, - Acute decompensated heart failure, - Acute pericarditis and myocarditis, - Complex arrhythmia, - Uncontrolled hypertension, - Serious orthopedic and neurological impairment, - Uncontrolled diabetes, - Body Mass Index > 30.

Study Design


Intervention

Other:
Standard respiratory physiotherapy
Standard respiratory physiotherapy content; diaphragmatic breathing, pursed lip breathing, segmental breathing, incentive spirometer exercises (Triflo) and coughing techniques.
Standard respiratory physiotherapy and inspiratory muscle training
Standard respiratory physiotherapy content; diaphragmatic breathing, pursed lip breathing, segmental breathing, incentive spirometer exercises (Triflo) and coughing techniques. Addition to that, threshold IMT device will be used for the training. Training intensity will set at 40% of the maximum inspiratory pressure.

Locations

Country Name City State
Turkey Acibadem MAA University Maslak Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline Forced Vital Capacity (FVC) at 4 weeks Four weeks
Primary Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 4 weeks Four weeks
Primary Change from baseline Peak Expiratory Flow (PEF) at 4 weeks Four weeks
Primary Change from baseline maximum inspiratory pressure (MIP) at 4 weeks Four weeks
Primary Change from baseline maximum expiratory pressure (MEP) at 4 weeks Four weeks
Primary Change from baseline distance covered in six-minute walk test (6MWT) at 4 weeks Four weeks
Primary Change from baseline carbon monoxide diffusion capacity of the lungs (DLCO) at 4 weeks Four weeks
Secondary Fatigue Severity Scale The 9 item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Assessment type: Patient reported outcomes.The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree.The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity. Four weeks
Secondary Fatigue Impact Scale The fatigue impact scale was developed to assess the symptom of fatigue as part of an underlying chronic disease or condition. Consisting of 40 items, the instrument evaluates the effect of fatigue on three domains of daily life: cognitive functioning, physical functioning, and psychosocial functioning. Respondents are asked to rate the extent to which fatigue has interfered with certain aspects of their day-to-day functioning using a scale that ranges from 0 ("no problem") to 4 ("extreme problem"). Scores are then tallied to produce an overall score with a potential maximum of 160. Subscale scores can also be calculated to give a more nuanced impression of fatigue. Four weeks
See also
  Status Clinical Trial Phase
Completed NCT04624412 - Different Intensities of Continuous Aerobic Exercises in Cardiac Rehab Phase 2 N/A
Completed NCT05563701 - Evaluation of the LVivo Image Quality Scoring (IQS)
Recruiting NCT04561908 - Transcatheter Microguidewire Drilling for Transseptal Left Atrial Access N/A
Active, not recruiting NCT06190743 - Perception of Cardiovascular Risk
Completed NCT04580095 - Artificial Intelligence for Improved Echocardiography N/A
Completed NCT04562636 - Evaluating a Messaging Campaign in the United States N/A
Recruiting NCT03277365 - MyGeneRank: A Digital Platform for Next-Generation Genetic Studies N/A
Active, not recruiting NCT05553106 - Evaluation of Cognitive Status, Kinesiophobia, Physical Activity Level, and Functional Performance in Coronary Intensive Care
Completed NCT03429920 - Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors N/A
Recruiting NCT04390672 - Multivessel TALENT N/A
Enrolling by invitation NCT03314818 - Natural History of Carotid Plaque as Determined by 3D Ultrasound N/A
Withdrawn NCT03289104 - Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX N/A
Completed NCT02917213 - Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
Completed NCT02046902 - Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection
Completed NCT01909349 - Web-based Aftercare Intervention for Cardiac Patients N/A
Completed NCT01944254 - The Precision of Pulmonary Artery Cardiac Output-measurements in Spontaneously Breathing Patients N/A
Recruiting NCT01457586 - Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery Phase 4
Recruiting NCT01541163 - Heart and Ischemic STrOke Relationship studY N/A
Recruiting NCT01207167 - Mediators of Atherosclerosis in South Asians Living in America
Completed NCT02645786 - Thyrotropin Over-suppression and Heart N/A