Power Lung Versus Acapella After Coronary Artery Bypass Graft Surgery

April 20, 2023 updated by: Shymaa yussuf abo zaid, South Valley University

Power Lung Versus Acapella on Airway Clearance After Coronary Artery Bypass Graft Surgery

The purpose of the study is to compare between the power lung versus acapella on airway clearance after coronary artery bypass graft surgery.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

In this part of the study the materials and methods will be presented under the following headings: subjects, equipments, procedures of the study and statistical procedures

  1. Subjects. Ninty patients of both sexes will participate in this study with an age range of 40 to 50 years old. They will be chosen from outpatient clinic, Qena University Hospital.

    Patients will be randomely assigned into three groups:

    Group A: patients will receive a two supervised sessions using acapella device three sets for 10 repetitions from the first day postoperative until 7 days, in addition to routine physiotherapy program (phase I cardiac rehabilitation, breathing exercises, postural drainage, percussion and vibration.

    Group B: patients will receive a two supervised session using power lung device three sets for 10 repetitions two times daily from first day postoperative until 7 days, in addition to routine physiotherapy program (phase I cardiac rehabilitation, breathing exercises, postural drainage, Percussion and vibration).

    Group C. Patients will receive only routine physical Therapy program.

  2. Equipment:

1. For evaluation: Arterial blood gases including: - paO2, paCO2, PH and O2 saturation. Spirometry measurements: - as forced vital capacity (FVC) andbforced expiratory volume in the first second (FEV1).

The incidence of PPCs and the length of postoperative stay: - using the Melbourne Group Scale Dyspnea. According to the revised or modified Borg scale or rating of perceived exersion.

The Rand SF 36 health survey questionnaire. 2. For treatment The power lung device. Acapella device.

Study Type

Interventional

Enrollment (Anticipated)

90

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 Contact

Study Contact Backup

Study Locations

  • Egypt
      • Qinā, Egypt
        • Shymaa yussuf abo zaid

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

40 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • They will be from 40-50 years old.
  • They will be patients undergo elective CABG surgery.
  • Non productive cough postoperatively.
  • Cough pain intensity > 5 as rated on a visual analogue scale (VAS) on postoperative day 1.

Exclusion Criteria:

  • Patients with chronic chest diseases.
  • Patients with an intensive postoperative care (ICU) stay > 48 hrs.
  • Uncooperative patients.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Group A. Thirty patients will receive a two supervised session using Acapella three sets for 10 repetitions two times daily from first day postoperative until 7 days, in addition to routine physiotherapy program (phase I cardiac rehabilitation, breathing exercises, postural drainage, Percussion and vibration).
Device: Acapella device
patients will receive a two supervised sessions using acapella device three sets for 10 repetitions from the first day postoperative until 7 days, in addition to routine physiotherapy program (phase I cardiac rehabilitation, breathing exercises, postural drainage, percussion and vibration.
Experimental: Group B
Thirty patients will receive a two supervised sessions using power lung device three sets for 10 repetitions from the first day postoperative until 7 days(André L.et al., 2016), in addition to routine physiotherapy program (phase I cardiac rehabilitation, breathing exercises, postural drainage, percussion and vibration).
Device: Power lung device
Group B. patients will receive a two supervised sessions using power lung device three sets for 10 repetitions from the first day postoperative until 7 days, in addition to routine physiotherapy program (phase I cardiac rehabilitation, breathing exercises, postural drainage, percussion and vibration.
Active Comparator: Group C
Thirty patients will receive only routine physical Therapy program.
Other: routine Physical Therapy program
Group C. Thirty patients will receive only routine physical Therapy program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial blood gases including:
Time Frame: One week
Partial pressure of oxygen (paO2), partial pressure of carbon dioxide (paCO2), power of hydrogen (PH)and O2 saturation.
One week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spirometry
Time Frame: One week
As forced vital capacity (FVC), forced expiratory volume in the first second (FEV1) and the FEV1/FVC.
One week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyspnea
Time Frame: One week
According to revised or modified Borg or rating of perceived exertion.
One week
The incidence of postoperative pulmonary complications
Time Frame: One week
According to Melbourne group scale.
One week
Quality of life
Time Frame: One week
According to the Rand SF 36 health survey questionnaire.
One week

Collaborators and Investigators

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

Sponsor

South Valley University

Investigators

  • Principal Investigator: Shymaa Y Abo zaid, Master, Assistant lecturer

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)

August 5, 2021

Primary Completion (Anticipated)

July 5, 2023

Study Completion (Anticipated)

August 5, 2023

Study Registration Dates

First Submitted

February 8, 2022

First Submitted That Met QC Criteria

February 19, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 20, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • P.T.REC/012/002682

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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