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Not yet recruiting NCT07367945

Incentive Spirometry Versus Inspiratory Muscle Training After Coronary Artery Bypass Grafting

No phase Interventional Coronary Artery Bypass Graft (CABG)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Incentive spirometry, Inspiratory muscle trainer, Routine physical therapy.
Who it may be relevant to
Registry conditions: Coronary Artery Bypass Graft (CABG). Basic parameters: 50 years — 60 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effect of Incentive Spirometry Versus Inspiratory Muscle Training on Arterial Blood Gases After Coronary Artery Bypass Grafting

Overview

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

Interventions

  • Device Incentive spirometry
    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 Inspiratory muscle trainer
    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).
  • Other Routine physical therapy
    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).

Primary outcome measures

  • Arterial Blood gas Parameters (PaO2 and SaO2) [Time frame: Baseline 5 days pre-surgery , Immediately after the surgery within 48 hours , and through study completion an average of 8 days.]
Secondary outcome measures (4)
  • Atelactasis [Time frame: 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) [Time frame: Baseline 5 days pre-surgery, and through study completion an average of 8 days.]
  • Physical function ICU test - scored (PFIT-s) [Time frame: Immediately after the surgery within 48 hours.]
  • Mechanical Ventilation duration [Time frame: from the end of surgery until successful extubation .]

Eligibility criteria

Inclusion criteria

  • 45 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Zagazig University Hospitals — Zagazig

Identifiers

NCT: NCT07367945 · P.T.REC/012/006065

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗