Acapella Versus Incentive Spirometer on Cardiopulmonary Fitness After Heart Valve Surgery.

Study Overview
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Brief Summary
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Valvular heart disease (VHD) is a growing and important public health problem due to the increasing prevalence of degenerative VHD, accompanied by prolonged life expectancy in developed countries. It is associated with high morbidity and mortality.Heart valve surgery is one of the proven treatments of VHD, which corrects hemodynamic abnormalities that could contribute to decrease mortality and improvement in quality of life, despite the improvement in the hemodynamic parameters, the cardiorespiratory fitness level remained low after heart valve surgery. Cardiac surgeries can cause a series of clinical and functional complication. Postoperative pulmonary complications are the most common, in turn, contribute directly to increase morbidity and mortality and longer hospital stays.Mucociliary clearance is affected after open-heart surgery by the effects of general anaesthesia, intubation and analgesia. Expiratory flow rate is directly related to lung volume and therefore when lung volumes are decreased, coughing will be less effective. Chest physical therapy plays an important role in the prevention and management of postoperative pulmonary complications. It includes deep breathing exercises, mobilization, postural drainage, percussion and vibration or shaking which were developed to improve bronchial drainage. Airway clearance techniques are commonly used for clearing secretions, improving gas exchange, oxygenation, and work of breathing. Acapella® is an airway clearance device that combines the resistive features of a positive expiratory pressure device with oscillations which diminishes the mucus adhesiveness and decrease the collapsibility of airways. In the present study, the aim is to compare the effect of acapella and incentive spirometer on cardiopulmonary fitness in patients undergoing heart valve surgery. Those patients may gain a more benefit from acapella application and incentive spirometer so, prevent post-operative pulmonary complication, reduce hospitalization and hospital costs, and improve quality of life. Therefore, early mobilization and chest physiotherapy including acapella and incentive will be started on 1st day after discharge from cardiac care unit (CCU) .

Detailed Description
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This study is designed to compare between effect of acapella and incentive spirometer on cardiopulmonary fitness after heart valve surgery.The patients of this study will randomly assigned into three equal groups in numbers. Study Group A will receive acapella protocol in addition to traditional chest physiotherapy, early mobilization and sternal precautions. Study Group B will receive incentive spirometer in addition to traditional chest physiotherapy, early mobilization and sternal precautions. Control Group C will receive traditional chest physiotherapy, early mobilization and sternal precautions. The program of treatment for each patient will be applied daily starting from the first day the patient will be extubated (2nd postoperative day) up to 7 days.

Official Title
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Acapella Versus Incentive Spirometer on Cardiopulmonary Fitness After Heart Valve Surgery.

Conditions
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Open Heart Surgery, Heart Valve Diseases, Heart Diseases

Intervention / Treatment
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* Device: Acapella user
* Device: Incentive spirometer user
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of both sexes with age ranges (30-40) years old. Patients with normal body mass index ranges (18.5-24.9) kg/m2 Patients undergo mitral valve surgery via median sternotomy. Post operative, extubated heart valve surgery patients, who were able to follow the instructions and sign the consent form. Patients with hemodynamic stability. Patients with controlled diabetes mellitus. Exclusion Criteria: - Patients who required more than 48 hours of intubation after surgery. Reintubation in post operative period. Patients who had history of respiratory tract infection within a period of three months. Patients undergo CABG ,or double valve surgery. Patients with any neuromuscular disease. Patients with severe renal dysfunction. Anemic patients. Uncontrolled diabetes mellitus.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acapella user<br>this group will use acapella in addition to traditional chest physiotherapy , early mobility and sternal precautions. | Device: Acapella user<br>* The exercise session will include three sets of deep breaths. Each set will include 10 repetitions which were fol¬lowed by 30 to 60 seconds pause in between. Patients will be instructed to perform slow maximal inspiration, while expiration was done through acapella in a prolonged manner to minimize airway closure and alveolar collapse. In the Acapella device, resistance was increased continuously on each successive day. The technique will be applied for 15 minutes. Components of Acapella® treatment will include : Breathing control 10 breaths through the Acapella® device Inhaling up to approximately three - quarter maximum breathing capacity 2-3 second breath hold Active exhalation to Functional residual capacity but not too forcefully (3-4 second) The patient did 2-3 huffs at the end of the session, Cough or forced expiration in a set cycle.<br>|
| Experimental: Incentive spirometer user<br>this group will receive incentive spirometer in addition to traditional chest physiotherapy, early mobility and sternal precautions. | Device: Incentive spirometer user<br>* Sit upright in a chair or in bed. Hold the incentive spirometer at eye level, hold a pillow to help splint or brace the incision to decrease pain at incision. Put the mouthpiece in mouth and close lips tightly around it. Slowly breathe out (exhale) completely. Breathe in (inhale) slowly through mouth as deeply as possible. As taking the breath, the ball will rise. Try to get the ball as high as possible. When getting it, hold breath for 10 seconds, or as long as possible. Then, breathe out slowly through mouth. Then, Rest for a 30-60 seconds. Repeat 10 times. Try to get the ball to the same level or higher with each breath. repeat 10 times for 3 sets.<br>|
| Other: Control user<br>this group will receive traditional chest physiotherapy , early mobility and sternal precautions. | Procedure: Control<br>* This group is a control group will not receive new intervention just traditional chest physiotherapy and mobilization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function test | Forced vital capacity and forced expiratory volume in one second will be measured | 7 days | 
| Peripheral oxygen saturation | Determine level of oxygen in blood | 7 days | 
| Rate of perceived exertion | Dysnpea level measured by modified borg scale from 0 to 10 0 no dyspnea at all 10 maximal degree of dyspnea | 7 days | 
| Pain intensity | Measured by visual analogue scale to determine degree of incisional pain 0 no pain 10 worst pain | 7 days | 
| Cardiorespiratory fitness evaluation | Vo2max is measured to determine functional capacity after operation | 7 days | 
| Length of hospital stay | Determine how many days patient need to be in hospital and become fully hemodynamically stable | Average 4 - 7 days |