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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT05267067
Collaborator
(none)
30
1
2
5
6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: respiratory exercises
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison Between the Manual Respiratory Exercises and Respiratory Pressure Meter
Actual Study Start Date :
Sep 2, 2020
Actual Primary Completion Date :
Jan 20, 2021
Actual Study Completion Date :
Feb 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Respiratory muscle strength [3 month]

    By respiratory pressure meter

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sahar Abdalbary Cairo Select State/province Egypt 11431

Sponsors and Collaborators

  • Cairo University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sahar Ahmed Abdalbary, Associate professor, Cairo University
ClinicalTrials.gov Identifier:
NCT05267067
Other Study ID Numbers:
  • Chest physiotherapy
First Posted:
Mar 4, 2022
Last Update Posted:
Mar 4, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 4, 2022