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

NCT05522712 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-08-31

No results posted yet for this study

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) .

Conditions

  • Open Heart Surgery
  • Heart Valve Diseases
  • Heart Diseases

Interventions

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.

DEVICE

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.

PROCEDURE

Control

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

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Zeinab M. Helmy, PhD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-01-01
Completion
2023-03-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05522712 on ClinicalTrials.gov