Post Coronary Artery Bypass GraftingNCT05684679
Effectiveness of Incentive Spirometer and Diaphragmatic Breathing Exercise on ABG Measures in Post-CABG Patients
A study testing Incentive spirometer plus Chest physiotherapy and Diaphragmatic breathing exercise plus Chest physiotherapy in people with Post Coronary Artery Bypass Grafting, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
The rate of pulmonary complications following Coronary artery bypass graft (CABG) is high. Early pulmonary exercises are important in preventing this complication following cardiac surgery. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Post Coronary Artery Bypass Grafting
- What is being tested?
- Incentive spirometer plus Chest physiotherapy and Diaphragmatic breathing exercise plus Chest physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Apr 2019to 25 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patient with post-CABG,
- Aged between 40 and 60 years,
- Had forced expiratory volume in 1 second (FEV1) <70% of predicted value,
- Showed FEV1/forced vital capacity (FVC) ratio >0.8,
- Weight equal or exceeded the ideal body weight by less than 20%, and
- Patient co-operation.
Who cannot join
- Aged more than 60 years,
- Weight equal or exceeded the ideal body weight by more than 20%,
- Post-operative respiratory treatment exceeding 20 hours,
- History of Chronic obstructive pulmonary disease (COPD) /thoracic surgery including CABG,
- had thoracic anomalies/unstable angina,
- Developed hemodynamic complication, and
- Non-cooperative/neurological debilitated patient.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Rehabilitation Research Chair, Department of Rehabilitation Sciences, king Saud University
Riyadh, Riyadh 11433, 10219
About this study
Official title: Efficacy of Incentive Spirometer and Diaphragmatic Breathing Exercise on the Alteration of Arterial Blood Gas Measures in Patients After Coronary Artery Bypass Grafting. A Randomized Comparative Study
The rate of pulmonary complications following Coronary artery bypass graft (CABG) is high. Early pulmonary exercises are important in preventing this complication following cardiac surgery. This study aimed to investigate the effectiveness of incentive spirometer (IS) and diaphragmatic breathing exercise (DBE) on the alteration of arterial blood gas (ABG) measures. The study was based on a two-arm, parallel-group, randomized comparative design. Thirty patients who underwent CABG enrolled in the study based on inclusion and exclusion criteria, randomly allocated into either of the groups, IS Group or DBE Group. IS Group and DBE Group underwent chest physiotherapy with IS and DBE, respectively. ABG measures, including PH of blood, partial pressure of arterial oxygen molecule (PaO2), and partial pressure of arterial carbon dioxide (PaCO2), was assessed using an ABG analyzer at baseline (pre-operation), day1 post-operation, and day2 post-operation. The significance level was kept constant for all statistical analyses at 95%.
Read the detailed description
Coronary artery bypass graft (CABG) is one of common treatment procedures performed worldwide. Evidence suggest that every year more than 1 million CABG procedure has been performed. Pulmonary complications are one of the most common consequence post CABG.
The incidence of atelectasis after heart operation with cardiopulmonary bypass is still 80-84% in spite of careful fluid \& respiratory management. The basic problem in respiratory care of post-surgical patient is atelectasis leading to hypoxemia causing alteration in arterial blood gases (ABGs). Associated with atelectasis are widening alveolar - arterial O2 gradient (as right to left intrapulmonary shunting increases) decrease ventilation perfusion ratio, decrease functional residual capacity and decrease compliance. Chest physiotherapy is routinely used after major abdominal \& cardiothoracic surgery to prevent these pulmonary complications following operation.
To date, there is a variable view about the effectiveness of these two primary breathing exercise techniques (incentive spirometer and diaphragmatic breathing exercise). 10-12 Hence an effort to systematically study the effectiveness of these is attempted. Thus, the current study aimed to determine the efficacy of incentive spirometer and diaphragmatic breathing exercises in addition to conventional chest physiotherapy on alteration of ABG measures in patients with post CABG. This study hypothesized that there will be a significant difference between the effect of the IS and DBE on ABG alteration in post CABG patients.
- Conditions
- Post Coronary Artery Bypass Grafting
- Being tested
- Incentive spirometer plus Chest physiotherapy, Diaphragmatic breathing exercise plus Chest physiotherapy
- Keywords
- Chest Physiotherapy, Incentive spirometer, Diaphragmatic breathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentive spirometer plus Chest physiotherapyOther
Also called Huffing, Coughing, Upper and lower limbs active exercises
Incentive spirometer was given to IS group. However, a conventional chest physiotherapy was given to both groups in the optimal position.
Diaphragmatic breathing exercise plus Chest physiotherapyOther
Also called Huffing, Coughing, Upper and lower limbs active exercises
Diaphragmatic breathing exercise was given to DBE group. In addition, a conventional chest physiotherapy was given in the optimal position.
| Study group | Role | What they receive |
|---|---|---|
| IS Group | Experimental | • Patients were instructed to utilize an incentive spirometer in the sitting or half lying position as taught preoperatively.
* 3 to 5 consecutive breath with the spirometer were interspersed between period of quite breathing.
* Duration 10-15 minutes/session. Receives: Other: Incentive spirometer plus Chest physiotherapy |
| DBE Group | Experimental | • Patients were advised to do diaphragmatic breathing exercise in the sitting or half lying position as taught preoperatively.
* 3 to 5 consecutive deep breath were interspersed between period of quite breathing.
* Duration 10-15 minutes/session. Receives: Other: Diaphragmatic breathing exercise plus Chest physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PH of Blood
PH of blood was assessed using an ABG analyzer machine
Measured: 3 Days
Partial pressure of Arterial Oxygen molecule (PaO2)
PaO2 was assessed using an ABG analyzer machine
Measured: 3 Days
Partial pressure of Arterial Carbon dioxide molecule (PaCO2)
PaCO2 was assessed using an ABG analyzer machine
Measured: 3 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start15 Apr 2019
- Primary completion30 Jul 2019
- Study completion25 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Coronary Artery Bypass GraftingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AMIR IQBAL, King Saud University
- Investigators
- AMIR IQBAL, MPT, Principal investigator, King Saud University, Riyadh, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684679
- Sponsor's protocol ID
- RRC-2019-13
- Status last verified
- Jan 2023
- First submitted
- 4 Jan 2023
- Last updated
- 18 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Incentive Spirometer and Diaphragmatic Breathing Exercise on the Alteration of Arterial Blood Gas Measures in Patients After Coronary Artery Bypass Grafting. A Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT05684679
- Acronym / sponsor ID
- RRC-2019-13
- Conditions
- Post Coronary Artery Bypass Grafting
- Keywords
- Chest Physiotherapy, Incentive spirometer, Diaphragmatic breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 25 Aug 2019 (actual)
- First posted
- 13 Jan 2023 (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.
The rate of pulmonary complications following Coronary artery bypass graft (CABG) is high. Early pulmonary exercises are important in preventing this complication following cardiac surgery. This study aimed to investigate the effectiveness of incentive spirometer (IS) and diaphragmatic breathing exercise (DBE) on the alteration of arterial blood gas (ABG) measures. The study was based on a two-arm, parallel-group, randomized comparative design. Thirty patients who underwent CABG enrolled in the study based on inclusion and exclusion criteria, randomly allocated into either of the groups, IS Group or DBE Group. IS Group and DBE Group underwent chest physiotherapy with IS and DBE, respectively. ABG measures, including PH of blood, partial pressure of arterial oxygen molecule (PaO2), and partial pressure of arterial carbon dioxide (PaCO2), was assessed using an ABG analyzer at baseline (pre-operation), day1 post-operation, and day2 post-operation. The significance level was kept constant for all statistical analyses at 95%.
Detailed description
Coronary artery bypass graft (CABG) is one of common treatment procedures performed worldwide. Evidence suggest that every year more than 1 million CABG procedure has been performed. Pulmonary complications are one of the most common consequence post CABG.
The incidence of atelectasis after heart operation with cardiopulmonary bypass is still 80-84% in spite of careful fluid \& respiratory management. The basic problem in respiratory care of post-surgical patient is atelectasis leading to hypoxemia causing alteration in arterial blood gases (ABGs). Associated with atelectasis are widening alveolar - arterial O2 gradient (as right to left intrapulmonary shunting increases) decrease ventilation perfusion ratio, decrease functional residual capacity and decrease compliance. Chest physiotherapy is routinely used after major abdominal \& cardiothoracic surgery to prevent these pulmonary complications following operation.
To date, there is a variable view about the effectiveness of these two primary breathing exercise techniques (incentive spirometer and diaphragmatic breathing exercise). 10-12 Hence an effort to systematically study the effectiveness of these is attempted. Thus, the current study aimed to determine the efficacy of incentive spirometer and diaphragmatic breathing exercises in addition to conventional chest physiotherapy on alteration of ABG measures in patients with post CABG. This study hypothesized that there will be a significant difference between the effect of the IS and DBE on ABG alteration in post CABG patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IS Group | Experimental | Other: Incentive spirometer plus Chest physiotherapy• Patients were instructed to utilize an incentive spirometer in the sitting or half lying position as taught preoperatively. * 3 to 5 consecutive breath with the spirometer were interspersed between period of quite breathing. * Duration 10-15 minutes/session. |
| DBE Group | Experimental | Other: Diaphragmatic breathing exercise plus Chest physiotherapy• Patients were advised to do diaphragmatic breathing exercise in the sitting or half lying position as taught preoperatively. * 3 to 5 consecutive deep breath were interspersed between period of quite breathing. * Duration 10-15 minutes/session. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The patient with post-CABG,
- Aged between 40 and 60 years,
- Had forced expiratory volume in 1 second (FEV1) <70% of predicted value,
- Showed FEV1/forced vital capacity (FVC) ratio >0.8,
- Weight equal or exceeded the ideal body weight by less than 20%, and
Key exclusion criteria (7 listed)
- Aged more than 60 years,
- Weight equal or exceeded the ideal body weight by more than 20%,
- Post-operative respiratory treatment exceeding 20 hours,
- History of Chronic obstructive pulmonary disease (COPD) /thoracic surgery including CABG,
- had thoracic anomalies/unstable angina,
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 |
|---|---|---|
| Incentive spirometer plus Chest physiotherapyAlso: Huffing, Coughing, Upper and lower limbs active exercisesIncentive spirometer was given to IS group. However, a conventional chest physiotherapy was given to both groups in the optimal position. | Other | IS Group |
| Diaphragmatic breathing exercise plus Chest physiotherapyAlso: Huffing, Coughing, Upper and lower limbs active exercisesDiaphragmatic breathing exercise was given to DBE group. In addition, a conventional chest physiotherapy was given in the optimal position. | Other | DBE Group |
Primary outcome
PH of Blood
Time frame: 3 Days
PH of blood was assessed using an ABG analyzer machine
Partial pressure of Arterial Oxygen molecule (PaO2)
Time frame: 3 Days
PaO2 was assessed using an ABG analyzer machine
Partial pressure of Arterial Carbon dioxide molecule (PaCO2)
Time frame: 3 Days
PaCO2 was assessed using an ABG analyzer machine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
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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.
AMIR IQBAL, MPT principal investigator
King Saud University, Riyadh, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incentive spirometer plus Chest physiotherapy and Diaphragmatic breathing exercise plus Chest physiotherapy in people with Post Coronary Artery Bypass Grafting, run by King Saud University at 1 site in Saudi Arabia.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PH of Blood (time frame: 3 Days). The study lists 3 primary outcomes in all. 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 18 Jan 2023.