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

February 23, 2022 updated by: Sahar Ahmed Abdalbary, Cairo University

Comparison Between the Manual Respiratory Exercises and Respiratory Pressure Meter

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Select State/province
      • Cairo, Select State/province, Egypt, 11431
        • Sahar Abdalbary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: manual respirtory exercises
Using manual traditional respiratory exercises.
Other: respiratory exercises
Manual respiratory exercises versus respiratory exercises with pressure meter
Active Comparator: Respiratory exercises with respiratory pressure meter
Using pressure respiratory meter in exercises.
Other: respiratory exercises
Manual respiratory exercises versus respiratory exercises with pressure meter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory muscle strength
Time Frame: 3 month
By respiratory pressure meter
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Abdallaha Mohamed, MD, Nahda University, Faculty of Physical Therapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2020

Primary Completion (Actual)

January 20, 2021

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

February 13, 2022

First Submitted That Met QC Criteria

February 23, 2022

First Posted (Actual)

March 4, 2022

Study Record Updates

Last Update Posted (Actual)

March 4, 2022

Last Update Submitted That Met QC Criteria

February 23, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Chest physiotherapy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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