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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05260944
Other study ID # P.T.REC/012/002682
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 5, 2021
Est. completion date August 5, 2023

Study information

Verified date April 2023
Source South Valley University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 90
Est. completion date August 5, 2023
Est. primary completion date July 5, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Coronary Artery Bypass Graft Surgery

Intervention

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.
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.
Other:
routine Physical Therapy program
Group C. Thirty patients will receive only routine physical Therapy program

Locations

Country Name City State
Egypt Shymaa yussuf abo zaid Qina

Sponsors (1)

Lead Sponsor Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Other Dyspnea According to revised or modified Borg or rating of perceived exertion. One week
Other The incidence of postoperative pulmonary complications According to Melbourne group scale. One week
Other Quality of life According to the Rand SF 36 health survey questionnaire. One week
Primary Arterial blood gases including: Partial pressure of oxygen (paO2), partial pressure of carbon dioxide (paCO2), power of hydrogen (PH)and O2 saturation. One week
Secondary Spirometry As forced vital capacity (FVC), forced expiratory volume in the first second (FEV1) and the FEV1/FVC. One week
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