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

Not Applicable

Completed

• Conditions: Heart Valve Diseases
• Interventions: Other: Power breath plus; Other: Diaphragmatic breathing exercises; Other: Incrementing the training load

• Registration Number: NCT06012474
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-05-15
• Study Completion: 2022-10-15
• Status Verified: 2023-08
• Study First Submitted: 2023-08-21
• Study First Submitted QC: 2023-08-23
• Last Update Submitted: 2023-08-23
• Study First Posted: 2023-08-25
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
inspiratory muscle training group	Power breath plus	30 patients will receive inspiratory muscle training by Power breath device once daily for 7 days.
inspiratory muscle training group	Incrementing the training load	30 patients will receive inspiratory muscle training by Power breath device once daily for 7 days.
diaphragmatic breathing exercise group	Diaphragmatic breathing exercises	20 patients will receive program of diaphragmatic breathing exercise by incentive spirometer once daily for 7 days.

Primary Outcome Measures

Name	Time	Method
Assessing the change in Arterial Blood gases	within 24 hours after 1 week of intervention	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 diaphragmatic excursion	within 24 hours after 1 week of intervention	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 capacity to perform daily activities	within 24 hours after 1 week of intervention	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).

Trial Locations

Locations (1)

Outpatient clinic faculty of physical therapy cairo university; 🇪🇬 Dokki, Egypt