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

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) .

Study Overview

• Status: Recruiting
• Conditions: Heart Diseases; Heart Valve Diseases; Open Heart Surgery
• Intervention / Treatment: Device: Acapella user; Device: Incentive spirometer user; Procedure: Control

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: El sayed Essam El sayed, PhD; Phone Number: 01007099643; Email: elsayedessam22@yahoo.com

Study Locations

• Egypt
  • Dokki
    • Giza, Dokki, Egypt, 12613
      • Recruiting
      • Faculty of physical therapy
      • Contact: El sayed Essam Elsayed, PhD; Phone Number: 01007099643; Email: elsayedessam22@yahoo.com
      • Contact: Zeinab Mohammed Helmy, PhD; Phone Number: 01114773311; Email: Helmy.zeinab@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acapella user; this group will use acapella in addition to traditional chest physiotherapy , early mobility and sternal precautions.	Device: 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.
Experimental: Incentive spirometer user; this group will receive incentive spirometer in addition to traditional chest physiotherapy, early mobility and sternal precautions.	Device: Incentive spirometer user; 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.
Other: Control user; this group will receive traditional chest physiotherapy , early mobility and sternal precautions.	Procedure: Control; This group is a control group will not receive new intervention just traditional chest physiotherapy and mobilization

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Zeinab M. Helmy, PhD, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): March 30, 2023

Study Registration Dates

• First Submitted: August 20, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): August 31, 2022

Study Record Updates

• Last Update Posted (Actual): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 30, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases
• Other Study ID Numbers: P.T.REC/012/003310

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No