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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05522712
Enrollment
60
Registered
2022-08-31
Start date
2022-01-01
Completion date
2023-03-30
Last updated
2022-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Diseases, Heart Valve Diseases, Open Heart Surgery

Brief summary

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

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.

Interventions

DEVICEAcapella 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.

DEVICEIncentive 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.

PROCEDUREControl

This group is a control group will not receive new intervention just traditional chest physiotherapy and mobilization

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
30 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pulmonary function test7 daysForced vital capacity and forced expiratory volume in one second will be measured
Peripheral oxygen saturation7 daysDetermine level of oxygen in blood
Rate of perceived exertion7 daysDysnpea level measured by modified borg scale from 0 to 10 0 no dyspnea at all 10 maximal degree of dyspnea
Pain intensity7 daysMeasured by visual analogue scale to determine degree of incisional pain 0 no pain 10 worst pain
Cardiorespiratory fitness evaluation7 daysVo2max is measured to determine functional capacity after operation
Length of hospital stayAverage 4 - 7 daysDetermine how many days patient need to be in hospital and become fully hemodynamically stable

Countries

Egypt

Contacts

Primary ContactEl sayed Essam El sayed, PhD
elsayedessam22@yahoo.com01007099643

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026