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Completed

NCT Number: NCT05267067

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

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.

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Key information

Conditions

Respiration Disorders Respiratory Tract Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahar Abdalbary

Cairo, Select State/province, 11431, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Respiratory exercises

Other

Manual respiratory exercises versus respiratory exercises with pressure meter

Primary outcomes

  1. Respiratory muscle strength

    Time frame: 3 month

    By respiratory pressure meter

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Comparison Between the Manual Respiratory Exercises and Respiratory Pressure Meter

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 4, 2022
Registry last updated
Mar 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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