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

NCT ID: NCT06012474

Last Updated: 2023-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-10-15

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.

Conditions

Heart Valve Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

inspiratory muscle training group

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

Group Type: EXPERIMENTAL

Power breath plus

Intervention Type: OTHER

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

Incrementing the training load

Intervention Type: OTHER

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.

diaphragmatic breathing exercise group

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

Group Type: ACTIVE_COMPARATOR

Diaphragmatic breathing exercises

Intervention Type: OTHER

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.

Interventions

Power breath plus

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

Incrementing the training load

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

Diaphragmatic breathing exercises

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hend Mahdy Hassan Mohamed

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hend Mahdy

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Outpatient clinic faculty of physical therapy cairo university

Dokki, , Egypt

Countries

Egypt

Other Identifiers

012/004209

Identifier Type: -

Identifier Source: org_study_id