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Effectiveness of Incentive Spirometer and Diaphragmatic Breathing Exercise on ABG Measures in Post-CABG Patients

Primary Purpose

Post Coronary Artery Bypass Grafting

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Incentive spirometer plus Chest physiotherapy
Diaphragmatic breathing exercise plus Chest physiotherapy
Sponsored by
King Saud University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Coronary Artery Bypass Grafting focused on measuring Chest Physiotherapy, Incentive spirometer, Diaphragmatic breathing

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rehabilitation Research Chair, Department of Rehabilitation Sciences, king Saud University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

IS Group

DBE Group

Arm Description

• 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.

• 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.

Outcomes

Primary Outcome Measures

PH of Blood
PH of blood was assessed using an ABG analyzer machine
Partial pressure of Arterial Oxygen molecule (PaO2)
PaO2 was assessed using an ABG analyzer machine
Partial pressure of Arterial Carbon dioxide molecule (PaCO2)
PaCO2 was assessed using an ABG analyzer machine

Secondary Outcome Measures

Full Information

First Posted
January 4, 2023
Last Updated
January 13, 2023
Sponsor
King Saud University
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1. Study Identification

Unique Protocol Identification Number
NCT05684679
Brief Title
Effectiveness of Incentive Spirometer and Diaphragmatic Breathing Exercise on ABG Measures in Post-CABG Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
August 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Coronary Artery Bypass Grafting
Keywords
Chest Physiotherapy, Incentive spirometer, Diaphragmatic breathing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IS Group
Arm Type
Experimental
Arm Description
• 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.
Arm Title
DBE Group
Arm Type
Experimental
Arm Description
• 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.
Intervention Type
Other
Intervention Name(s)
Incentive spirometer plus Chest physiotherapy
Other Intervention Name(s)
Huffing, Coughing, Upper and lower limbs active exercises
Intervention Description
Incentive spirometer was given to IS group. However, a conventional chest physiotherapy was given to both groups in the optimal position.
Intervention Type
Other
Intervention Name(s)
Diaphragmatic breathing exercise plus Chest physiotherapy
Other Intervention Name(s)
Huffing, Coughing, Upper and lower limbs active exercises
Intervention Description
Diaphragmatic breathing exercise was given to DBE group. In addition, a conventional chest physiotherapy was given in the optimal position.
Primary Outcome Measure Information:
Title
PH of Blood
Description
PH of blood was assessed using an ABG analyzer machine
Time Frame
3 Days
Title
Partial pressure of Arterial Oxygen molecule (PaO2)
Description
PaO2 was assessed using an ABG analyzer machine
Time Frame
3 Days
Title
Partial pressure of Arterial Carbon dioxide molecule (PaCO2)
Description
PaCO2 was assessed using an ABG analyzer machine
Time Frame
3 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AMIR IQBAL, MPT
Organizational Affiliation
King Saud University, Riyadh, Saudi Arabia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Research Chair, Department of Rehabilitation Sciences, king Saud University
City
Riyadh
State/Province
Riyadh 11433
ZIP/Postal Code
10219
Country
Saudi Arabia

12. IPD Sharing Statement

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Effectiveness of Incentive Spirometer and Diaphragmatic Breathing Exercise on ABG Measures in Post-CABG Patients

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