- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05684679
Effectiveness of Incentive Spirometer and Diaphragmatic Breathing Exercise on ABG Measures in Post-CABG Patients
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
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Riyadh 11433
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Riyadh, Riyadh 11433, Saudi Arabia, 10219
- Rehabilitation Research Chair, Department of Rehabilitation Sciences, king Saud University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: IS Group
• Patients were instructed to utilize an incentive spirometer in the sitting or half lying position as taught preoperatively.
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Incentive spirometer was given to IS group.
However, a conventional chest physiotherapy was given to both groups in the optimal position.
Other Names:
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Experimental: DBE Group
• Patients were advised to do diaphragmatic breathing exercise in the sitting or half lying position as taught preoperatively.
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Diaphragmatic breathing exercise was given to DBE group.
In addition, a conventional chest physiotherapy was given in the optimal position.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PH of Blood
Time Frame: 3 Days
|
PH of blood was assessed using an ABG analyzer machine
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3 Days
|
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Partial pressure of Arterial Oxygen molecule (PaO2)
Time Frame: 3 Days
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PaO2 was assessed using an ABG analyzer machine
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3 Days
|
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Partial pressure of Arterial Carbon dioxide molecule (PaCO2)
Time Frame: 3 Days
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PaCO2 was assessed using an ABG analyzer machine
|
3 Days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: AMIR IQBAL, MPT, KING SAUD UNIVERSITY, Riyadh, Saudi Arabia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RRC-2019-13
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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