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

NCT ID: NCT05267067

Last Updated: 2022-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-02
• Study Completion Date: 2021-02-01

Brief 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.

Detailed 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.

Conditions

Respiration Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

manual respirtory exercises

Using manual traditional respiratory exercises.

Group Type: ACTIVE_COMPARATOR

respiratory exercises

Intervention Type: OTHER

Manual respiratory exercises versus respiratory exercises with pressure meter

Respiratory exercises with respiratory pressure meter

Using pressure respiratory meter in exercises.

Group Type: ACTIVE_COMPARATOR

respiratory exercises

Intervention Type: OTHER

Manual respiratory exercises versus respiratory exercises with pressure meter

Interventions

respiratory exercises

Manual respiratory exercises versus respiratory exercises with pressure meter

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Sahar Ahmed Abdalbary

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdallaha Mohamed, MD

Role: STUDY_CHAIR

Nahda University, Faculty of Physical Therapy

Locations

Sahar Abdalbary

Cairo, Select State/province, Egypt

Countries

Egypt

Other Identifiers

Chest physiotherapy

Identifier Type: -

Identifier Source: org_study_id