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

January 13, 2023 updated by: AMIR IQBAL, King Saud University

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%.

Study Overview

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

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Riyadh 11433
      • Riyadh, Riyadh 11433, Saudi Arabia, 10219
        • Rehabilitation Research Chair, Department of Rehabilitation Sciences, king Saud University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.

  • 3 to 5 consecutive breath with the spirometer were interspersed between period of quite breathing.
  • Duration 10-15 minutes/session.
Incentive spirometer was given to IS group. However, a conventional chest physiotherapy was given to both groups in the optimal position.
Other Names:
  • Huffing, Coughing, Upper and lower limbs active exercises
Experimental: DBE Group

• 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.
Diaphragmatic breathing exercise was given to DBE group. In addition, a conventional chest physiotherapy was given in the optimal position.
Other Names:
  • Huffing, Coughing, Upper and lower limbs active exercises

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
3 Days
Partial pressure of Arterial Oxygen molecule (PaO2)
Time Frame: 3 Days
PaO2 was assessed using an ABG analyzer machine
3 Days
Partial pressure of Arterial Carbon dioxide molecule (PaCO2)
Time Frame: 3 Days
PaCO2 was assessed using an ABG analyzer machine
3 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: AMIR IQBAL, MPT, KING SAUD UNIVERSITY, Riyadh, Saudi Arabia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2019

Primary Completion (Actual)

July 30, 2019

Study Completion (Actual)

August 25, 2019

Study Registration Dates

First Submitted

January 4, 2023

First Submitted That Met QC Criteria

January 5, 2023

First Posted (Actual)

January 13, 2023

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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