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

Not Applicable

• Conditions: Open Heart Surgery; Heart Valve Diseases; Heart Diseases
• Interventions: Device: Incentive spirometer user; Procedure: Control; Device: Acapella user

• Registration Number: NCT05522712
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2022-08
• Study First Submitted: 2022-08-20
• Study First Submitted QC: 2022-08-30
• Last Update Submitted: 2022-08-30
• Study First Posted: 2022-08-31
• Last Update Posted: 2022-08-31
• Primary Completion: 2023-01-01
• Study Completion: 2023-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Incentive spirometer user	Incentive spirometer user	this group will receive incentive spirometer in addition to traditional chest physiotherapy, early mobility and sternal precautions.
Control user	Control	this group will receive traditional chest physiotherapy , early mobility and sternal precautions.
Acapella user	Acapella user	this group will use acapella in addition to traditional chest physiotherapy , early mobility and sternal precautions.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of physical therapy; 🇪🇬 Giza, Dokki, Egypt