## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** RRC-2019-13
#### Organization
**Class:** OTHER
**Full Name:** King Saud University
### Status Module
#### Completion Date
**Date:** 2019-08-25

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-01-18

**Type:** ACTUAL

**Last Update Submit Date:** 2023-01-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-07-30

**Type:** ACTUAL

#### Start Date
**Date:** 2019-04-15

**Type:** ACTUAL

**Status Verified Date:** 2023-01

#### Study First Post Date
**Date:** 2023-01-13
**Type:** ACTUAL
**Study First Submit Date:** 2023-01-04
**Study First Submit QC Date:** 2023-01-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** King Saud University

#### Responsible Party

**Investigator Affiliation:** King Saud University

**Investigator Full Name:** AMIR IQBAL

**Investigator Title:** Prinicipal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Post Coronary Artery Bypass Grafting

**Keywords:**

- Chest Physiotherapy

- Incentive spirometer

- Diaphragmatic breathing

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Other: Incentive spirometer plus Chest physiotherapy

**Label:** IS Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**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 Names:**

- Other: Diaphragmatic breathing exercise plus Chest physiotherapy

**Label:** DBE Group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- IS Group

**Description:** Incentive spirometer was given to IS group. However, a conventional chest physiotherapy was given to both groups in the optimal position.

**Name:** Incentive spirometer plus Chest physiotherapy

**Other Names:**

- Huffing, Coughing, Upper and lower limbs active exercises

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- DBE Group

**Description:** Diaphragmatic breathing exercise was given to DBE group. In addition, a conventional chest physiotherapy was given in the optimal position.

**Name:** Diaphragmatic breathing exercise plus Chest physiotherapy

**Other Names:**

- Huffing, Coughing, Upper and lower limbs active exercises

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** PH of blood was assessed using an ABG analyzer machine

**Measure:** PH of Blood

**Time Frame:** 3 Days

**Description:** PaO2 was assessed using an ABG analyzer machine

**Measure:** Partial pressure of Arterial Oxygen molecule (PaO2)

**Time Frame:** 3 Days

**Description:** PaCO2 was assessed using an ABG analyzer machine

**Measure:** Partial pressure of Arterial Carbon dioxide molecule (PaCO2)

**Time Frame:** 3 Days

### Eligibility Module

**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.

**Maximum Age:** 60 Years

**Minimum Age:** 40 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Riyadh

**Country:** Saudi Arabia

**Facility:** Rehabilitation Research Chair, Department of Rehabilitation Sciences, king Saud University

**State:** Riyadh 11433

**Zip:** 10219

#### Overall Officials

**Official 1:**

**Affiliation:** King Saud University, Riyadh, Saudi Arabia

**Name:** AMIR IQBAL, MPT

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012120

- Term: Respiration Disorders

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M27137

- Name: Respiratory Aspiration

- Relevance: HIGH

- As Found: Breathing

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000053120

- Term: Respiratory Aspiration

### Misc Info Module

- Version Holder: 2024-05-24
