Acapella Versus Incentive Spirometer on Cardiopulmonary Fitness After Heart Valve Surgery.
1 other identifier
interventional
60
1 country
1
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) .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedFirst Submitted
Initial submission to the registry
August 20, 2022
CompletedFirst Posted
Study publicly available on registry
August 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2023
CompletedAugust 31, 2022
August 1, 2022
1 year
August 20, 2022
August 30, 2022
Conditions
Outcome Measures
Primary Outcomes (6)
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
Study Arms (3)
Acapella user
EXPERIMENTALthis group will use acapella in addition to traditional chest physiotherapy , early mobility and sternal precautions.
Incentive spirometer user
EXPERIMENTALthis group will receive incentive spirometer in addition to traditional chest physiotherapy, early mobility and sternal precautions.
Control user
OTHERthis group will receive traditional chest physiotherapy , early mobility and sternal precautions.
Interventions
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.
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.
This group is a control group will not receive new intervention just traditional chest physiotherapy and mobilization
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of physical therapy
Giza, Dokki, 12613, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zeinab M. Helmy, PhD
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
August 20, 2022
First Posted
August 31, 2022
Study Start
January 1, 2022
Primary Completion
January 1, 2023
Study Completion
March 30, 2023
Last Updated
August 31, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share