Coronary Artery Bypass GraftCABG ACBT ABGNCT06705556
Effect of Active Cycle of Breathing Technique as Add on to Routine Chest Physical Therapy on Respiratory Parameters in Coronary Artery Bypass Graft Patients
A study testing Active cycle of breathing technique, incentive spirometer, percussion, 3-minute of walking and incentive spirometer, percussion, 3-minute of walking in people with Coronary Artery Bypass Graft, run by Sadaf Bukhari at 2 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Coronary Artery Bypass Graft
- What is being tested?
- Active cycle of breathing technique, incentive spirometer, percussion, 3-minute of walking and incentive spirometer, percussion, 3-minute of walking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Mar 2024to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective coronary artery bypass graft patients
- The study included both male and female
- 30 to 65 years old patients were included in this study
- Adults with stable coronary artery disease for the last 15 years
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
The University of Faisalabad
Faisalabad, Punjab Province, 37000
Dr Sana Ashraf
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Pre and Post Operative Active Cycle of Breathing Technique as Add on to Routine Chest Physical Therapy on Respiratory Parameters in Coronary Artery Bypass Graft Patients
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:
Read more
- 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.
Read the detailed description
This single-blinded randomized controlled trial was conducted at the Faisalabad Institute of Cardiology, Faisalabad, Pakistan, to assess the effects the Active Cycle of Breathing Technique (ACBT) as add on to routine chest physical therapy in the preoperative care of coronary artery bypass graft (CABG) patients. The primary aim was to evaluate ACBT's impact on minimizing postoperative respiratory complications. A secondary aim was to educate patients in the preoperative period to reduce surgery-related stress and support respiratory drive.
Patients with coronary artery disease are generally advised bed rest to manage shortness of breath. However, CABG is an invasive procedure that involves the placement of an endotracheal tube, raising infection risks and leading to weakened respiratory muscles due to ventilation effects. Post-surgery, patients often experience reduced lung volumes and altered arterial blood gases. Adding ACBT to chest physical therapy in the preoperative period is intended to improve ventilation and arterial blood gas levels postoperatively.
The study involved 72 male and female patients, aged 30 to 65, with double or triple-vessel coronary disease and a 10 to 15-year disease history, scheduled for CABG. Screening was performed using a custom questionnaire based on inclusion and exclusion criteria, and non-probability purposive sampling was used to select participants. Patients were randomly assigned to either the intervention or control group using the lottery method. The intervention group received ACBT alongside routine chest physical therapy, while the control group received only standard chest physical therapy, both pre- and postoperatively. Patient confidentiality was maintained through informed consent.
Key study parameters included arterial blood gas (ABG) levels, oxygen saturation (SpO2), and respiratory rate, with ABG samples taken from the brachial and radial arteries and analyzed via an ABG analyzer. SpO2 was measured using a pulse oximeter, and respiratory rate was recorded on a cardiac monitor.
- Conditions
- Coronary Artery Bypass Graft
- Being tested
- Active cycle of breathing technique, incentive spirometer, percussion, 3-minute of walking, incentive spirometer, percussion, 3-minute of walking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active cycle of breathing technique, incentive spirometer, percussion, 3-minute of walkingProcedure or surgery
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
incentive spirometer, percussion, 3-minute of walkingProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: incentive spirometer, percussion, 3-minute of walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (Oxygen Saturation) is a measurement that estimates the percentage of oxygen-saturated hemoglobin in the blood. SpO₂ monitoring is vital in clinical settings, especially for patients with respiratory or cardiac conditions, during and after surgery.
Measured: 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 (RR) refers to the number of breaths a person takes per minute. It is a key vital sign used to assess breathing and overall respiratory function.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 Mar 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass GraftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sadaf Bukhari
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sadaf Bukhari, University of Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705556
- Sponsor's protocol ID
- Tuf/IRB/292/24
- Acronym
- CABG ACBT ABG
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pre and Post Operative Active Cycle of Breathing Technique as Add on to Routine Chest Physical Therapy on Respiratory Parameters in Coronary Artery Bypass Graft Patients
- ClinicalTrials.gov ID
- NCT06705556
- Acronym / sponsor ID
- CABG ACBT ABG / Tuf/IRB/292/24
- Conditions
- Coronary Artery Bypass Graft
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Sadaf BukhariUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This single-blinded randomized controlled trial was conducted at the Faisalabad Institute of Cardiology, Faisalabad, Pakistan, to assess the effects the Active Cycle of Breathing Technique (ACBT) as add on to routine chest physical therapy in the preoperative care of coronary artery bypass graft (CABG) patients. The primary aim was to evaluate ACBT's impact on minimizing postoperative respiratory complications. A secondary aim was to educate patients in the preoperative period to reduce surgery-related stress and support respiratory drive.
Patients with coronary artery disease are generally advised bed rest to manage shortness of breath. However, CABG is an invasive procedure that involves the placement of an endotracheal tube, raising infection risks and leading to weakened respiratory muscles due to ventilation effects. Post-surgery, patients often experience reduced lung volumes and altered arterial blood gases. Adding ACBT to chest physical therapy in the preoperative period is intended to improve ventilation and arterial blood gas levels postoperatively.
The study involved 72 male and female patients, aged 30 to 65, with double or triple-vessel coronary disease and a 10 to 15-year disease history, scheduled for CABG. Screening was performed using a custom questionnaire based on inclusion and exclusion criteria, and non-probability purposive sampling was used to select participants. Patients were randomly assigned to either the intervention or control group using the lottery method. The intervention group received ACBT alongside routine chest physical therapy, while the control group received only standard chest physical therapy, both pre- and postoperatively. Patient confidentiality was maintained through informed consent.
Key study parameters included arterial blood gas (ABG) levels, oxygen saturation (SpO2), and respiratory rate, with ABG samples taken from the brachial and radial arteries and analyzed via an ABG analyzer. SpO2 was measured using a pulse oximeter, and respiratory rate was recorded on a cardiac monitor.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Experimental | Procedure: Active cycle of breathing technique, incentive spirometer, percussion, 3-minute of walkingThe 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 |
| The control group | Experimental | Procedure: incentive spirometer, percussion, 3-minute of walkingThe 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 |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective coronary artery bypass graft patients
- The study included both male and female
- 30 to 65 years old patients were included in this study
- Adults with stable coronary artery disease for the last 15 years
Key exclusion criteria (6 listed)
- Patient with unstable vitals
- Preoperative pulmonary dysfunction
- COPD or Emphysema
- Asthma and Severe atelectasis
- Renal disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active cycle of breathing technique, incentive spirometer, percussion, 3-minute of walkingThe 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 | Procedure or surgery | The intervention group |
| incentive spirometer, percussion, 3-minute of walkingThe 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 | Procedure or surgery | The control group |
Primary outcome
Arterial blood gas
Time frame: 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.
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.
2 secondary outcomes
oxygen saturation (SpO₂)
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Individual participant dataSharing planned: No
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Coronary Artery Bypass Graft (CABG)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active cycle of breathing technique, incentive spirometer, percussion, 3-minute of walking and incentive spirometer, percussion, 3-minute of walking in people with Coronary Artery Bypass Graft, run by Sadaf Bukhari at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial blood gas (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.