- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07367945
Incentive Spirometry Versus Inspiratory Muscle Training After Coronary Artery Bypass Grafting (IS/ IMT)
Effect of Incentive Spirometry Versus Inspiratory Muscle Training on Arterial Blood Gases After Coronary Artery Bypass Grafting
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eman A Ismail
- Phone Number: +201126821576
- Email: e.mohsen.637496@gmail.com
Study Locations
-
-
Alsharqia
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Zagazig, Alsharqia, Egypt, 44519
- Zagazig University Hospitals
-
Contact:
- principle investigator
- Phone Number: +200552304832
- Email: info@zu.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: IS
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).
|
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).
Other Names:
|
|
Experimental: IMT
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).
|
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 Names:
|
|
Active Comparator: Control group
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).
|
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Atelactasis
Time Frame: Baseline 5 days pre-surgery, Immediately after the surgery within 48 hours, and through study completion an average of 8 days.
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Assessment of lung collapse using chest X-ray and CT or clinical findings.
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Baseline 5 days pre-surgery, Immediately after the surgery within 48 hours, and through study completion an average of 8 days.
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Functional capacity (2- minute walk test)
Time Frame: Baseline 5 days pre-surgery, and through study completion an average of 8 days.
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measuring the maximum distance a patient can walk on a flat surface in 2-minutes to evaluate functional exercise capacity.
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Baseline 5 days pre-surgery, and through study completion an average of 8 days.
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Physical function ICU test - scored (PFIT-s)
Time Frame: Immediately after the surgery within 48 hours.
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Assessment of physical function in the ICU through four components ( sit -to- stand, marching, shoulder flexion, and knee extension ) Scored (0 - 10).
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Immediately after the surgery within 48 hours.
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Mechanical Ventilation duration
Time Frame: from the end of surgery until successful extubation .
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the total number of hours the patient required mechanical ventilation support after CABG surgery
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from the end of surgery until successful extubation .
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/006065
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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