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Effect Of Power Breath Device On Arterial Blood Gases And Diaphragmatic Excursion After Valve Surgery

Primary Purpose

Heart Valve Diseases

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Power breath plus
Incrementing the training load
Diaphragmatic breathing exercises
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Valve Diseases

Eligibility Criteria

25 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Female patients with valve surgery (valve replacement or repair with median sternotomy procedure). Age between 25 to 35 years old. BMI is between 18.5 to 24.5 kg/m2. Exclusion Criteria: The participants will be excluded if they meet one of the following criteria: Uncontrolled hypertension (systolic blood pressure>230 mm Hg and diastolic blood pressure>120 mm Hg) Patients with coronary artery disease or heart failure. Need for mechanical ventilation for >24 h or reintubation. Renal and hepatic disorders. Infected or unstable sternum. patient with pneumothorax after surgery. Metabolic disorders. Pregnant woman. Lactating mother. Smokers Stroke patient

Sites / Locations

  • Outpatient clinic faculty of physical therapy cairo university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

inspiratory muscle training group

diaphragmatic breathing exercise group

Arm Description

30 patients will receive inspiratory muscle training by Power breath device once daily for 7 days.

20 patients will receive program of diaphragmatic breathing exercise by incentive spirometer once daily for 7 days.

Outcomes

Primary Outcome Measures

Assessing the change in diaphragmatic excursion
By using Ultrasonography (Aloka prosound 4000, made in Japan) that will be used to assess diaphragmatic excursion. Diaphragmatic excursion is measured 3 times :at baseline before surgical intervention, second day after surgery (before the training program) and after 7 days of training program for all patient in the two groups. Diaphragmatic excursion was measured during deep breathing while the patient in semi-recumbent position on a comfortable bed using ultrasonography.
Assessing the change in Arterial Blood gases
Arterial blood gases are measured at baseline before surgical intervention, second day after surgery (before the training program) and after 7 days of training program for all patient in the two groups and can be obtained by direct arterial puncture most usually at the wrist (radial artery), femoral and brachial artery. An arterial blood sample (2 to 3 ml) will be collected.
Assessing the change in capacity to perform daily activities
by using the The 6-min walk test (6MWT) is a submaximal functional test indicative of the capacity to perform daily activities, patients will be asked to walk along a 30-m, flat and straight hospital corridor. Encouragement will be offered every minute, so that subjects will walk as far as possible. Symptom-limited interruptions (dyspnea, skeletal muscle pain, angina, dizziness) will allowed, though patients will be invited to resume walking as soon as possible. Most tests will be supervised by a physical therapist. Distance will be recorded in meters. Subjective dyspnea will quantified according to Borg Scale, ranging from 0 (no dyspnea) to 10 (severe dyspnea).

Secondary Outcome Measures

Full Information

First Posted
August 21, 2023
Last Updated
August 23, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT06012474
Brief Title
Effect Of Power Breath Device On Arterial Blood Gases And Diaphragmatic Excursion After Valve Surgery
Official Title
Effect Of Power Breath Device On Arterial Blood Gases And Diaphragmatic Excursion After Valve Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
May 15, 2022 (Actual)
Study Completion Date
October 15, 2022 (Actual)

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to evaluate the effect of power breath device on arterial blood gases, diaphragmatic excursion and the 6 min walk test after cardiac valve surgery.
Detailed Description
No more studies have been done on the effect of IMT by power breath on valvular surgery, So, this study will see the effect of power breath device on arterial blood gases, diaphragmatic excursion and six minute walk test after valve surgery to know enhanced recovery protocols in valvular surgery that accelerate the functional recovery, minimize the length of the hospital stay and decrease cost of treatment.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
inspiratory muscle training group
Arm Type
Experimental
Arm Description
30 patients will receive inspiratory muscle training by Power breath device once daily for 7 days.
Arm Title
diaphragmatic breathing exercise group
Arm Type
Active Comparator
Arm Description
20 patients will receive program of diaphragmatic breathing exercise by incentive spirometer once daily for 7 days.
Intervention Type
Other
Intervention Name(s)
Power breath plus
Intervention Description
Power breath plus use a variable load calibrated spring. It can be adjusted from the lowest load setting (17cmH2O) when training began and increased as the patient breathing muscles adapt and become stronger (maximum load setting 274cmH2O). Use a comfortable chair, preferably straight-back so that the spine is straight at all times during the exercise. patients will be instructed to exhale calmly, followed by a maximal forced inspiration to total lung capacity using a mouthpiece and a nasal clip as an aid to prevent air leaks and will ask to make 10 breaths for 3 sets once daily for 7 days with 2min rest between sets
Intervention Type
Other
Intervention Name(s)
Incrementing the training load
Intervention Description
The resistance will be increased incrementally, based on the rate of perceived exertion (RPE) scored by the patient on the modified Borg Scale. If the RPE is less than 5, the resistance of the inspiratory trainer will be increased incrementally by 2cmH2O. The resistance will not change if the level of perceived exertion is rated from 6 to 8, and the resistance will be decreased by 1 to 2 cmH2O if the level of perceived exertion is rated 9 or 10.
Intervention Type
Other
Intervention Name(s)
Diaphragmatic breathing exercises
Intervention Description
Training by using incentive spirometer: Loosen any tight clothing, especially around neck. Each patient will be instructed to sit upright with placing incentive spirometer at the same level of his mouth to promote optimal lung expansion while using the spirometer. The patient will be instructed to exhale letting all the breath out. patient will asked to close the lips around the mouthpiece of the spirometer. patient will be instructed to inhale slowly, breathing in until unable to do any more, this would raise the balls to the top of the column. patient will be asked to hold the breath as long as possible (at least five seconds) then exhale slowly. Session will be in the form of 30 times in sets, each set consist of 5-6 repetitions with rest 1 minute between sets. Intensity of exercise will be increased by increasing time of session, time of holding the breath and numbers of repetitions according to patient's status.
Primary Outcome Measure Information:
Title
Assessing the change in diaphragmatic excursion
Description
By using Ultrasonography (Aloka prosound 4000, made in Japan) that will be used to assess diaphragmatic excursion. Diaphragmatic excursion is measured 3 times :at baseline before surgical intervention, second day after surgery (before the training program) and after 7 days of training program for all patient in the two groups. Diaphragmatic excursion was measured during deep breathing while the patient in semi-recumbent position on a comfortable bed using ultrasonography.
Time Frame
within 24 hours after 1 week of intervention
Title
Assessing the change in Arterial Blood gases
Description
Arterial blood gases are measured at baseline before surgical intervention, second day after surgery (before the training program) and after 7 days of training program for all patient in the two groups and can be obtained by direct arterial puncture most usually at the wrist (radial artery), femoral and brachial artery. An arterial blood sample (2 to 3 ml) will be collected.
Time Frame
within 24 hours after 1 week of intervention
Title
Assessing the change in capacity to perform daily activities
Description
by using the The 6-min walk test (6MWT) is a submaximal functional test indicative of the capacity to perform daily activities, patients will be asked to walk along a 30-m, flat and straight hospital corridor. Encouragement will be offered every minute, so that subjects will walk as far as possible. Symptom-limited interruptions (dyspnea, skeletal muscle pain, angina, dizziness) will allowed, though patients will be invited to resume walking as soon as possible. Most tests will be supervised by a physical therapist. Distance will be recorded in meters. Subjective dyspnea will quantified according to Borg Scale, ranging from 0 (no dyspnea) to 10 (severe dyspnea).
Time Frame
within 24 hours after 1 week of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female patients with valve surgery (valve replacement or repair with median sternotomy procedure). Age between 25 to 35 years old. BMI is between 18.5 to 24.5 kg/m2. Exclusion Criteria: The participants will be excluded if they meet one of the following criteria: Uncontrolled hypertension (systolic blood pressure>230 mm Hg and diastolic blood pressure>120 mm Hg) Patients with coronary artery disease or heart failure. Need for mechanical ventilation for >24 h or reintubation. Renal and hepatic disorders. Infected or unstable sternum. patient with pneumothorax after surgery. Metabolic disorders. Pregnant woman. Lactating mother. Smokers Stroke patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hend Mahdy
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Outpatient clinic faculty of physical therapy cairo university
City
Dokki
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect Of Power Breath Device On Arterial Blood Gases And Diaphragmatic Excursion After Valve Surgery

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