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NCT05267067 Clinical Trial

Impact of Positive End Maximum Voluntary Ventilation and Dyspnea Index in Patients After Valvular Heart Surgery

Respiration Disorders Clinical Trial

Official title:
Comparison Between the Manual Respiratory Exercises and Respiratory Pressure Meter

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05267067
Other study ID # Chest physiotherapy
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2, 2020
Est. completion date February 1, 2021

Study information
Verified date February 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Pulmonary mechanics are further disturbed after cardiothoracic surgery that manifests like restrictive pathology, which may persist for weeks to months postoperatively. This experimental aimed to investigate the efficacy of a positive end-expiratory pressure device on maximum expiratory pressure, maximum voluntary ventilation, and dyspnea index in patients who underwent valve surgery.

Description:

Thirty male and female adolescent patients who underwent valve surgery aged 12-18 years old, recruited from the national heart institute enrolled in this experimental. They were assigned into two matched groups: Experimental group consisted of 15 patients, received positive end-expiratory pressure (PEEP) with a mouthpiece in addition to routine chest physiotherapy (postural drainage, percussion, vibration, and deep breathing exercises). Control group consisted of 15 patients, received routine chest physiotherapy alone. The program continued for four weeks.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date February 1, 2021
Est. primary completion date January 20, 2021
Accepts healthy volunteers No
Gender All
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria: - Male patients - underwent valve surgery (repair or replacement) for mitral valve stenosis; - hemodynamically stable, - ages ranged from 12 to 18 years old- - BMI ranges from 18.5 to 24.9 - reduced MEP, MVV and complaining from shortness of breath with exertion. Exclusion Criteria: - Patients with previous cardiac surgery - congenital heart disease - neurological disorders - type1 diabetes mellitus - smoker - pacemaker implantation - atrial fibrillation - utilization of mechanical ventilation longer than 24 hours.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• respiratory exercises
Manual respiratory exercises versus respiratory exercises with pressure meter

Locations
Country Name City State
Egypt Sahar Abdalbary Cairo Select State/province

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Respiratory muscle strength By respiratory pressure meter 3 month
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