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

Primary Purpose

Open Heart Surgery, Heart Valve Diseases, Heart Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Acapella user
Incentive spirometer user
Control
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open Heart Surgery

Eligibility Criteria

30 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of physical therapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Acapella user

Incentive spirometer user

Control user

Arm Description

this group will use acapella in addition to traditional chest physiotherapy , early mobility and sternal precautions.

this group will receive incentive spirometer in addition to traditional chest physiotherapy, early mobility and sternal precautions.

this group will receive traditional chest physiotherapy , early mobility and sternal precautions.

Outcomes

Primary Outcome Measures

Pulmonary function test
Forced vital capacity and forced expiratory volume in one second will be measured
Peripheral oxygen saturation
Determine level of oxygen in blood
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
Pain intensity
Measured by visual analogue scale to determine degree of incisional pain 0 no pain 10 worst pain
Cardiorespiratory fitness evaluation
Vo2max is measured to determine functional capacity after operation
Length of hospital stay
Determine how many days patient need to be in hospital and become fully hemodynamically stable

Secondary Outcome Measures

Full Information

First Posted
August 20, 2022
Last Updated
August 30, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05522712
Brief Title
Acapella Versus Incentive Spirometer on Cardiopulmonary Fitness After Heart Valve Surgery.
Official Title
Acapella Versus Incentive Spirometer on Cardiopulmonary Fitness After Heart Valve Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Heart Surgery, Heart Valve Diseases, Heart Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acapella user
Arm Type
Experimental
Arm Description
this group will use acapella in addition to traditional chest physiotherapy , early mobility and sternal precautions.
Arm Title
Incentive spirometer user
Arm Type
Experimental
Arm Description
this group will receive incentive spirometer in addition to traditional chest physiotherapy, early mobility and sternal precautions.
Arm Title
Control user
Arm Type
Other
Arm Description
this group will receive traditional chest physiotherapy , early mobility and sternal precautions.
Intervention Type
Device
Intervention Name(s)
Acapella user
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Incentive spirometer user
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
This group is a control group will not receive new intervention just traditional chest physiotherapy and mobilization
Primary Outcome Measure Information:
Title
Pulmonary function test
Description
Forced vital capacity and forced expiratory volume in one second will be measured
Time Frame
7 days
Title
Peripheral oxygen saturation
Description
Determine level of oxygen in blood
Time Frame
7 days
Title
Rate of perceived exertion
Description
Dysnpea level measured by modified borg scale from 0 to 10 0 no dyspnea at all 10 maximal degree of dyspnea
Time Frame
7 days
Title
Pain intensity
Description
Measured by visual analogue scale to determine degree of incisional pain 0 no pain 10 worst pain
Time Frame
7 days
Title
Cardiorespiratory fitness evaluation
Description
Vo2max is measured to determine functional capacity after operation
Time Frame
7 days
Title
Length of hospital stay
Description
Determine how many days patient need to be in hospital and become fully hemodynamically stable
Time Frame
Average 4 - 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
El sayed Essam El sayed, PhD
Phone
01007099643
Email
elsayedessam22@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeinab M. Helmy, PhD
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of physical therapy
City
Giza
State/Province
Dokki
ZIP/Postal Code
12613
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
El sayed Essam Elsayed, PhD
Phone
01007099643
Email
elsayedessam22@yahoo.com
First Name & Middle Initial & Last Name & Degree
Zeinab Mohammed Helmy, PhD
Phone
01114773311
Email
Helmy.zeinab@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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