NCT05260944

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 5, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2023

Completed
Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

1.9 years

First QC Date

February 8, 2022

Last Update Submit

April 20, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Spirometry

    One week

Other Outcomes (3)

  • Dyspnea

    One week

  • The incidence of postoperative pulmonary complications

    One week

  • Quality of life

    One week

Study Arms (3)

Group A

EXPERIMENTAL

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

Group B

EXPERIMENTAL

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 C

ACTIVE COMPARATOR

Thirty patients will receive only routine physical Therapy program.

Other: routine Physical Therapy program

Interventions

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 A

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.

Group B

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

Group C

Eligibility Criteria

Age40 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shymaa yussuf abo zaid

Qina, Egypt

Location

Study Officials

  • Shymaa Y Abo zaid, Master

    Assistant lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
The participants are the patients who undergoing coronary artery bypass graft surgery. The care providers are the cardiothoraci surgeon and the nursing staff. The investigator is the physical Therapy ( my self)
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: In the study three groups of patients will participated first, group A. Will receive acapella device. Second, group B. Will receive power lung device. Third, group C. Will receive only routine physical Therapy program.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

February 8, 2022

First Posted

March 2, 2022

Study Start

August 5, 2021

Primary Completion

July 5, 2023

Study Completion

August 5, 2023

Last Updated

April 21, 2023

Record last verified: 2023-04

Locations