Back to results

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

Primary Purpose

Respiration Disorders

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

respiratory exercises

About this trial

This is an interventional treatment trial for Respiration Disorders

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sahar Abdalbary

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

manual respirtory exercises

Respiratory exercises with respiratory pressure meter

Arm Description

Using manual traditional respiratory exercises.

Using pressure respiratory meter in exercises.

Outcomes

Primary Outcome Measures

Respiratory muscle strength

By respiratory pressure meter

Secondary Outcome Measures

Full Information

NCT ID

NCT05267067

First Posted

February 13, 2022

Last Updated

February 23, 2022

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT05267067

Brief Title

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

Official Title

Comparison Between the Manual Respiratory Exercises and Respiratory Pressure Meter

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

September 2, 2020 (Actual)

Primary Completion Date

January 20, 2021 (Actual)

Study Completion Date

February 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiration Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

manual respirtory exercises

Arm Type

Active Comparator

Arm Description

Using manual traditional respiratory exercises.

Arm Title

Respiratory exercises with respiratory pressure meter

Arm Type

Active Comparator

Arm Description

Using pressure respiratory meter in exercises.

Intervention Type

Other

Intervention Name(s)

respiratory exercises

Intervention Description

Manual respiratory exercises versus respiratory exercises with pressure meter

Primary Outcome Measure Information:

Title

Respiratory muscle strength

Description

By respiratory pressure meter

Time Frame

3 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Abdallaha Mohamed, MD

Organizational Affiliation

Nahda University, Faculty of Physical Therapy

Official's Role

Study Chair

Facility Information:

Facility Name

Sahar Abdalbary

City

Cairo

State/Province

Select State/province

ZIP/Postal Code

11431

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs