NCT06705556

Brief Summary

A controlled trial was conducted to determine the effect of the active cycle of breathing technique (ACBT) in improving respiratory parameters after coronary artery bypass graft surgery. The main aim of this study was to determine the effects of pre and postoperative active cycle of breathing technique (ACBT) in coronary artery disease patients undergoing coronary artery bypass graft surgery in improving respiratory parameters such as arterial blood gas (ABG), oxygen saturation (SpO2) and respiratory rate. The intervention group performed an active cycle of breathing technique with routine chest physical therapy while the control group performed routine chest physical therapy. Arterial blood gas (ABG), oxygen saturation (SpO2), and respiratory rate were measured at baseline and five days after surgery, every 2 hours on postoperative days 1, 2, and 3 and 4 hours on days 4 and 5. Participants in the intervention group performed preoperative routine chest physical therapy sessions were followed as:

  • Incentive spirometry, 3 sessions per day, 10 repetitions
  • Percussions, 3 sessions per day, 20 repetitions
  • 3-minutes walking, 2 sessions per day
  • ACBT, 3 sessions per day The preoperative chest physiotherapy treatment plan was continued after CABG surgery. In addition to these, the following were included postoperatively:
  • Nebulization, 3 sessions per day
  • 3 minutes of walking, 2 sessions per day
  • ACBT, 3 sessions per day While participants in the control group performed the same pre and postoperative sessions except ACBT.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

9 months

First QC Date

November 18, 2024

Last Update Submit

November 21, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Arterial blood gas

    Arterial Blood Gas (ABG) is a critical test used to evaluate a patient's acid-base balance, oxygenation, and ventilation status by measuring the levels of oxygen (O₂), carbon dioxide (CO₂), and bicarbonate (HCO₃-) in arterial blood.

    ABG test was conducted once preoperative for both groups and after surgery every 2 hours on postoperative days 1, 2, and 3, and every 4 hours on days 4 and 5.

Secondary Outcomes (2)

  • oxygen saturation (SpO₂)

    SpO₂ was measured once preoperative for both groups and after surgery every 2 hours on postoperative days 1, 2, and 3, and every 4 hours on days 4 and 5.

  • Respiratory rate

    Respiratory rate was measured once preoperative for both groups and after surgery every 2 hours on postoperative days 1, 2, and 3, and every 4 hours on days 4 and 5.

Study Arms (2)

The intervention group

EXPERIMENTAL

The intervention group: The intervention group (n=36) was instructed to perform the ACBT with routine chest physical therapy pre and postoperatively. The preoperative chest physical therapy was conducted 3 days before surgery and the postoperative CPT, including ACBT, was performed 3 times in the ICU for up to 5 days after surgery. Preoperative routine chest physical therapy sessions were followed as: * Incentive spirometer, 3 sessions per day, 10 repetitions * Percussions, 3 sessions per day, 20 repetitions * 3-minutes walking, 2 sessions per day * ACBT, 3 sessions per day The preoperative chest physiotherapy treatment plan was continued after CABG surgery. In addition to these, the following were included postoperatively: * Nebulization, 3 sessions per day * 3 minutes of walking, 2 sessions per day * ACBT, 3 sessions per day

Procedure: Active cycle of breathing technique, incentive spirometer, percussion, 3-minute of walking

The control group

EXPERIMENTAL

The control group: The routine Chest physical therapy was performed 3 days before surgery at the preoperative bay and 5 days after surgery in the ICU with 3 sessions each day. Preoperative chest physical therapy sessions were followed as: * Incentive spirometer, 3 sessions per day, 10 repetitions. * Percussions, 3 sessions per day, 20 repetitions. * 3-minutes walking, 2 sessions per day The preoperative chest physiotherapy treatment plan was continued after CABG surgery. In addition to these, the following were included postoperatively: * Nebulization, 3 sessions per day * 3-minutes walking, 2 sessions per day

Procedure: incentive spirometer, percussion, 3-minute of walking

Interventions

The intervention group: patients were asked to perform Active cycle of breathing technique as add on to routine chest physical therapy such as Incentive spirometer, percussion, 3-minute of walking 3 days before surgery and five days postoperative. * Incentive spirometry, 3 sessions per day, 10 repetitions * Percussions, 3 sessions per day, 20 repetitions * 3-minutes walking, 2 sessions per day * ACBT, 3 sessions per day the following were included postoperatively: * Nebulization, 3 sessions per day * ACBT, 3 sessions per day

The intervention group

The control group The routine CPT was performed 3 days before surgery at the preoperative bay and 5 days after surgery in the ICU with 3 sessions each day. Preoperative chest physical therapy sessions were followed as: * Incentive spirometry, 3 sessions per day, 10 repetitions. * Percussions, 3 sessions per day, 20 repetitions. * 3-minutes walking, 2 sessions per day The preoperative chest physiotherapy treatment plan was continued after CABG surgery. In addition to these, the following were included postoperatively: * Nebulization, 3 sessions per day * 3-minutes walking, 2 sessions per day

The control group

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective coronary artery bypass graft patients
  • The study included both male and female
  • to 65 years old patients were included in this study
  • Adults with stable coronary artery disease for the last 15 years

You may not qualify if:

  • Patient with unstable vitals
  • Preoperative pulmonary dysfunction
  • COPD or Emphysema
  • Asthma and Severe atelectasis
  • Renal disorders
  • Connected to the ventilator for more than 48 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The University of Faisalabad

Faisalabad, Punjab Province, 37000, Pakistan

Location

Dr Sana Ashraf

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Interventions

Walking

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The study was single, and assessor blinded. Participants were masked about other groups, but they were knowing what treatment they were receiving. Principal investigator was also not masked or blinded because investigator was applying the techniques on participants of both groups. So participant and principal investigator cannot be blinded. Only assessor was blind and was taken outcome measures without knowing the problem and treatment techniques.
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 18, 2024

First Posted

November 26, 2024

Study Start

March 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 20, 2024

Last Updated

November 26, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations