Open Heart SurgeryNCT05522712
Acapella Versus Incentive Spirometer on Cardiopulmonary Fitness After Heart Valve Surgery.
A study testing Acapella user and Incentive spirometer user in people with Open Heart Surgery and Heart Valve Diseases, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 40 years
- Conditions the study is for
- Open Heart Surgery, Heart Valve Diseases, Heart Diseases
- What is being tested?
- Acapella user and Incentive spirometer user
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- - 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of physical therapy
Giza, Dokki, 12613
El sayed Essam Elsayed, PhD, 01007099643, elsayedessam22@yahoo.com
Zeinab Mohammed Helmy, PhD, 01114773311, Helmy.zeinab@gmail.com
About this study
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.
Read more
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) .
Read the 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.
- Conditions
- Open Heart Surgery, Heart Valve Diseases, Heart Diseases
- Being tested
- Acapella user, Incentive spirometer user, Control
- Medical subject headings
- Heart Valve Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acapella userDevice
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.
Incentive spirometer userDevice
- 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.
ControlProcedure or surgery
This group is a control group will not receive new intervention just traditional chest physiotherapy and mobilization
| Study group | Role | What they receive |
|---|---|---|
| Acapella user | Experimental | this group will use acapella in addition to traditional chest physiotherapy , early mobility and sternal precautions. Receives: Device: Acapella user |
| Incentive spirometer user | Experimental | this group will receive incentive spirometer in addition to traditional chest physiotherapy, early mobility and sternal precautions. Receives: Device: Incentive spirometer user |
| Control user | Other | this group will receive traditional chest physiotherapy , early mobility and sternal precautions. Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function test
Forced vital capacity and forced expiratory volume in one second will be measured
Measured: 7 days
Peripheral oxygen saturation
Determine level of oxygen in blood
Measured: 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
Measured: 7 days
Pain intensity
Measured by visual analogue scale to determine degree of incisional pain 0 no pain 10 worst pain
Measured: 7 days
Cardiorespiratory fitness evaluation
Vo2max is measured to determine functional capacity after operation
Measured: 7 days
Length of hospital stay
Determine how many days patient need to be in hospital and become fully hemodynamically stable
Measured: Average 4 - 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start1 Jan 2022
- Primary completion1 Jan 2023 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Heart SurgeryStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samira Abdelrehim Mahmoud shehata, Cairo University
- Investigators
- Zeinab M. Helmy, PhD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522712
- Sponsor's protocol ID
- P.T.REC/012/003310
- Status last verified
- Aug 2022
- First submitted
- 20 Aug 2022
- Last updated
- 31 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acapella Versus Incentive Spirometer on Cardiopulmonary Fitness After Heart Valve Surgery.
- ClinicalTrials.gov ID
- NCT05522712
- Acronym / sponsor ID
- P.T.REC/012/003310
- Conditions
- Open Heart Surgery, Heart Valve Diseases, Heart Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acapella user | Experimental | Device: Acapella userthis group will use acapella in addition to traditional chest physiotherapy , early mobility and sternal precautions. |
| Incentive spirometer user | Experimental | Device: Incentive spirometer userthis group will receive incentive spirometer in addition to traditional chest physiotherapy, early mobility and sternal precautions. |
| Control user | Other | Procedure: Controlthis group will receive traditional chest physiotherapy , early mobility and sternal precautions. |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acapella userThe 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 | Acapella user |
| Incentive spirometer user1. 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. | Device | Incentive spirometer user |
| ControlThis group is a control group will not receive new intervention just traditional chest physiotherapy and mobilization | Procedure or surgery | Control user |
Primary outcome
Pulmonary function test
Time frame: 7 days
Forced vital capacity and forced expiratory volume in one second will be measured
Peripheral oxygen saturation
Time frame: 7 days
Determine level of oxygen in blood
Rate of perceived exertion
Time frame: 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
Time frame: 7 days
Measured by visual analogue scale to determine degree of incisional pain 0 no pain 10 worst pain
Cardiorespiratory fitness evaluation
Time frame: 7 days
Vo2max is measured to determine functional capacity after operation
Length of hospital stay
Time frame: Average 4 - 7 days
Determine how many days patient need to be in hospital and become fully hemodynamically stable
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeinab M. Helmy, PhD study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acapella user and Incentive spirometer user in people with Open Heart Surgery and Heart Valve Diseases, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact El sayed Essam El sayed, PhD (01007099643, elsayedessam22@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary function test (time frame: 7 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022.