Clinical trial NCT05522712: Acapella Versus Incentive Spirometer on Cardiopulmonary Fitness After Heart Valve Surgery.
Official title: Acapella Versus Incentive Spirometer on Cardiopulmonary Fitness After Heart Valve Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Open Heart Surgery
Heart Valve Diseases
Heart Diseases
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-08-31
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pulmonary function test
timeFrame: 7 days
measure: Peripheral oxygen saturation
timeFrame: 7 days
measure: Rate of perceived exertion
timeFrame: 7 days
measure: Pain intensity
timeFrame: 7 days
measure: Cardiorespiratory fitness evaluation
timeFrame: 7 days
measure: Length of hospital stay
timeFrame: Average 4 - 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy
state: Dokki
Study officials:
affiliation: Cairo University
name: Zeinab M. Helmy, PhD
role: STUDY_CHAIR
References: