Acapella Versus Incentive Spirometer on Cardiopulmonary Fitness After Heart Valve Surgery.
NCT ID: NCT05522712
Last Updated: 2022-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2022-01-01
2023-03-30
Brief Summary
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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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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Acapella user
this group will use acapella in addition to traditional chest physiotherapy , early mobility and sternal precautions.
Acapella user
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.
Incentive spirometer user
this group will receive incentive spirometer in addition to traditional chest physiotherapy, early mobility and sternal precautions.
Incentive spirometer user
1. 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.
2. Put the mouthpiece in mouth and close lips tightly around it. Slowly breathe out (exhale) completely.
3. Breathe in (inhale) slowly through mouth as deeply as possible. As taking the breath, the ball will rise.
4. Try to get the ball as high as possible.
5. When getting it, hold breath for 10 seconds, or as long as possible.
6. Then, breathe out slowly through mouth. Then, Rest for a 30-60 seconds.
7. Repeat 10 times. Try to get the ball to the same level or higher with each breath.
8. repeat 10 times for 3 sets.
Control user
this group will receive traditional chest physiotherapy , early mobility and sternal precautions.
Control
This group is a control group will not receive new intervention just traditional chest physiotherapy and mobilization
Interventions
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Acapella user
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.
Incentive spirometer user
1. 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.
2. Put the mouthpiece in mouth and close lips tightly around it. Slowly breathe out (exhale) completely.
3. Breathe in (inhale) slowly through mouth as deeply as possible. As taking the breath, the ball will rise.
4. Try to get the ball as high as possible.
5. When getting it, hold breath for 10 seconds, or as long as possible.
6. Then, breathe out slowly through mouth. Then, Rest for a 30-60 seconds.
7. Repeat 10 times. Try to get the ball to the same level or higher with each breath.
8. repeat 10 times for 3 sets.
Control
This group is a control group will not receive new intervention just traditional chest physiotherapy and mobilization
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
40 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Samira Abdelrehim Mahmoud shehata
Principal investigator
Principal Investigators
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Zeinab M. Helmy, PhD
Role: STUDY_CHAIR
Cairo University
Locations
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Faculty of physical therapy
Giza, Dokki, Egypt
Countries
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Central Contacts
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Facility Contacts
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El sayed Essam Elsayed, PhD
Role: primary
Zeinab Mohammed Helmy, PhD
Role: backup
Other Identifiers
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P.T.REC/012/003310
Identifier Type: -
Identifier Source: org_study_id