Incentive Spirometry Versus Inspiratory Muscle Training After Coronary Artery Bypass Grafting

NCT07367945 | Not Yet Recruiting DMC

• 1 other identifier: P.T.REC/012/006065
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted to compare between incentive spirometry verses inspiratory muscle training preoperatively on (ABG) after coronary artery bypass graft surgery. Is there any significant difference of preoperative incentive spirometry verses inspiratory muscle training on Arterial blood gases (ABG) after coronary artery bypass graft surgery? Participants will: Group A (incentive spirometry group ) Group B (Inspiratory muscle trainer group ) for 5 days before operative Group C (control group) and group a , b will have routinely postoperative

Conditions

Coronary Artery Bypass Graft (CABG)

Outcome Measures

Primary Outcomes (1)

• Arterial Blood gas Parameters (PaO2 and SaO2)

  Assessment of arterial oxygenation changes by measuring PaO2 and SaO2 . data will be collected at Baseline pre-surgery (5 days ) , Immediately after the surgery (within 48 hours) , and through study completion an average of 8 days.to evaluate the recovery trend and the effectiveness of respiratory interventions.

  Baseline 5 days pre-surgery , Immediately after the surgery within 48 hours , and through study completion an average of 8 days.

Secondary Outcomes (4)

• Atelactasis

  Baseline 5 days pre-surgery, Immediately after the surgery within 48 hours, and through study completion an average of 8 days.

• Functional capacity (2- minute walk test)

  Baseline 5 days pre-surgery, and through study completion an average of 8 days.

• Physical function ICU test - scored (PFIT-s)

  Immediately after the surgery within 48 hours.

• Mechanical Ventilation duration

  from the end of surgery until successful extubation .

Study Arms (3)

IS

EXPERIMENTAL

This group will include 15 patients, Incentive spirometry was utilized by the patient with ten breaths, six sets per day for a period of 10 min within patient tolerance in every session for five days with routinely physical therapy program (education and explanation) preoperatively, And postoperatively treatment (breathing treatment, deep-breathing applications, guided coughing, early mobilization).

Device: Incentive spirometry

IMT

EXPERIMENTAL

This group will include 15 patients, each session consisted of 30 minutes of inspiratory muscle training. The patients were trained to use an inspiratory threshold-loading device (Threshold Inspiratory Muscle Training) for five days with routinely physical therapy program (education and explanation) preoperatively, And postoperatively treatment (breathing treatment, deep-breathing applications, guided coughing, early mobilization).

Device: Inspiratory muscle trainer

Control group

ACTIVE COMPARATOR

15 patients will receive for 5 days routinely physical therapy program (education and explanation) preoperatively, And postoperatively treatment (breathing treatment, deep-breathing applications, guided coughing, early mobilization).

Other: Routine physical therapy

Interventions

Incentive spirometry DEVICE

This group will include 15 patients, Incentive spirometry was utilized by the patient with ten breaths, six sets per day for a period of 10 min within patient tolerance in every session for five days with routinely physical therapy program (education and explanation) preoperatively, And postoperatively treatment (breathing treatment, deep-breathing applications, guided coughing, early mobilization).

Also known as: IS

IS

Inspiratory muscle trainer DEVICE

This group will include 15 patients, each session consisted of 30 minutes of inspiratory muscle training. The patients were trained to use an inspiratory threshold-loading device (Threshold Inspiratory Muscle Training) for five days with routinely physical therapy program (education and explanation) preoperatively, And postoperatively treatment (breathing treatment, deep-breathing applications, guided coughing, early mobilization).

Also known as: IMT

IMT

Routine physical therapy OTHER

15 patients will receive for 5 days routinely physical therapy program (education and explanation) preoperatively, And postoperatively treatment (breathing treatment, deep-breathing applications, guided coughing, early mobilization).

Also known as: Control group

Control group

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• male patients will be included in this study.
• Patients with age from 50 to 60 years old (undergoing coronary artery bypass graft surgery) through median sternotomy.
• Their body mass index from 25 to 29.9 kg/m2
• Patients will be alert and able to follow instruction.

You may not qualify if:

• Who are expected not to be able to conduct or comply with IS and IMT.
• Patients with cognitive or neurological deficits.
• Patients with coexisting acute or chronic respiratory disorders.
• Patients unable to understand or show the proper use of the incentive spirometer and Inspiratory muscle training .
• Patients who cannot be instructed or supervised to assure appropriate use of the device patients in whom cooperation is absent or patients unable to understand or demonstrate proper use of the devices (inspiratory muscle training and incentive spirometry).
• Patients who are confused or delirious.
• Patients undergoing any other surgery along with CABG.
• Patients undergoing emergency CABG surgery.
• Chronic obstructive pulmonary disease (COPD), asthma, restrictive lung disease, preoperative major chest infection e.g. pulmonary tuberculosis, chest deformities such as pectus carinatum, pectus excavatum, thoracolumbar scoliosis, diaphragmatic hernias diagnosed on history.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Zagazig University Hospitals

Zagazig, Alsharqia, 44519, Egypt

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Eman A Ismail

CONTACT

+201126821576; e.mohsen.637496@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physical therapist

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 26, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 26, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)