Effects of E-care Protocol in Patients With Coronary Artery Bypass Graft

NCT07574411 | Not Yet Recruiting DMC

• 2 other identifiers: Laiba rani64146
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

Coronary artery disease (CAD) is a heart disease caused by the buildup of plaque inside the coronary arteries that restricts blood flow to the heart which leads to heart attack. If it involve more than one artery it will be more critical so the preferred treatment will be coronary artery bypass graft. Respiratory failure after Coronary Artery Bypass Grafting (CABG) is a serious complication with multifactorial causes i.e. pneumonia and atelectasis in inpatients. Postoperative pulmonary complications will be diagnosed using the Melbourne Group Scale (MGS), applied daily from postoperative day 1 to day 7. A score of ≥4 positive criteria will be used to identify PPCs. The scale's criteria will include chest radiograph findings, oxygen saturation, sputum characteristics, inflammatory markers, and ventilation data, physician diagnosis of pneumonia, readmission to ICU for respiratory reasons, prolong ventilation\> 24 hours, unplanned use of non-invasive ventilation.

Conditions

CABG

Keywords

CAD; CABG; E CARE protocol; RESPIRATORY FAILURE

Outcome Measures

Primary Outcomes (1)

• change in Length of stay

  Length of stay in ward will be noted

  Total days 7

Study Arms (2)

Group B

ACTIVE COMPARATOR

Device: IMT Threshold device

Group A

NO INTERVENTION

Interventions

IMT Threshold device DEVICE

Group A will receive standard rehabilitation treatment for inpatients. This includes the physical reconditioning, promote patient independence, Provide education about lifestyle changes and respiratory muscle strength. For example Day 1-2(Sitting up in bed or in a chair, Breathing exercises (incentive spirometer) and Coughing with pillow support (to protect the sternum).Day 2-3(Standing and walking short distances with assistance and Gentle range-of- motion (ROM) exercises. Day 4-5 (Walk longer distances (50-100 meters) and Stair climbing (if appropriate). It's necessary to monitor the vital signs (HR, BP, O2 saturation), pain levels, wound inspection and signs of orthostatic intolerance or arrhythmias. 6.1 IMT (Inspiratory muscle training) via use of IMT threshold Device: In comfortable sitting position IMT threshold device will be applied to the patient. Device will properly fitted to the patients mouth and set the resistance according to the patient respiratory muscle strength af

Also known as: Ankle pump, Bed pedal exercise

Group B

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female of \>45 years diagnosed with CAD and are undergone Coronary Artery Bypass Graft with stable circulation.
• Stable vitals.
• With normal cognition and being able to cooperate with the CR training.
• Agreed to participate in the trial and signed the consent for .

You may not qualify if:

• Pregnant
• Undergoing aortic surgery or equivalent surgery within 6 months
• History of cardiogenic shock or sudden cardiac arrest and severe hypertension
• Having complications with persistent ischemia, hemodynamic impairment, or at risk of arterial occlusion with massive myocardial infarction
• Having complications with unstable angina, malignant arrhythmia

Sponsors & Collaborators

• Riphah International University: lead

Related Publications (14)

• 14. Maisel, W.H., J.D. Rawn, and W.G.J.A.o.i.m. Stevenson, Atrial fibrillation after cardiac surgery. 2001. 135(12): p. 1061-1073.

  BACKGROUND

• 13. Rajaei, S. and A. Dabbagh, Risk factors for postoperative respiratory mortality and morbidity in patients undergoing coronary artery bypass grafting. Anesthesiology and Pain Medicine, 2012. 2(2): p. 60.

  BACKGROUND

• 12. Deb, S., et al., Coronary artery bypass graft surgery vs percutaneous interventions in coronary revascularization: a systematic review. Jama, 2013. 310(19): p. 2086-2095.

  BACKGROUND

• 11. Kazem, S.S., et al., Pulmonary physiotherapy effect on patients undergoing open cardiac surgery. Russian open medical journal, 2014. 3(3): p. 306.

  BACKGROUND

• 10. Head, S.J., et al., Stroke rates following surgical versus percutaneous coronary revascularization. 2018. 72(4): p. 386-398

  BACKGROUND

• 9. Zanini, M., et al., Effects of different rehabilitation protocols in inpatient cardiac rehabilitation after coronary artery bypass graft surgery: a randomized clinical trial. Journal of cardiopulmonary rehabilitation and prevention, 2019. 39(6): p. E19-E25.

  BACKGROUND

• 8. Tajti, P., et al., In-Hospital Outcomes of Chronic Total Occlusion Percutaneous Coronary Interventions in Patients with Prior Coronary Artery Bypass Graft Surgery: Insights From an International Multicenter Chronic Total Occlusion Registry. Circulation: Cardiovascular Interventions, 2019. 12(3): p. e007338.

  BACKGROUND

• 7. Members, W.C., et al., 2021 ACC/AHA/SCAI guideline for coronary artery revascularization: executive summary: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Journal of the American College of Cardiology, 2022. 79(2): p. 197-215

  BACKGROUND

• 6. Zhang, S., et al., The effects of inspiratory muscle training (IMT) on patients undergoing coronary artery bypass graft (CABG) surgery: a systematic review and meta-analysis. 2023. 24(1): p. 16.

  BACKGROUND

• 5. Hochman, J.S., et al., Survival after invasive or conservative management of stable coronary disease. Circulation, 2023. 147(1): p. 8-19.

  BACKGROUND

• 4. Fernandes, G.C., et al., Determinants of early and late in-hospital mortality after acute myocardial infarction: a subanalysis of the OBTAIN registry. 2023. 39(4): p. 531-537.

  BACKGROUND

• 3. Redfors, B., et al., Outcomes according to coronary revascularization modality in the ISCHEMIA trial. 2024. 83(5): p. 549-558.

  BACKGROUND

• 2. Araújo, C.O., et al., Inspiratory muscle training in phase 1 and 2 postoperative cardiac rehabilitation following coronary artery bypass graft surgery: systematic review with meta- analysis. Physical therapy, 2024. 104(7): p. pzae061.

  BACKGROUND

• 1. Yang Q, Wang L, Zhang X, Lu P, Pan D, Li S, Ling Y, Zhi X, Xia L, Zhu Y, Chen Y. Impact of an enhanced recovery after surgery program integrating cardiopulmonary rehabilitation on post-operative prognosis of patients treated with CABG: protocol of the ERAS-CaRe randomized controlled trial. BMC Pulmonary Medicine. 2024 Oct 14;24(1):512.Villareal, R.P., et al., Postoperative atrial fibrillation and mortality after coronary artery bypass surgery. 2004. 43(5): p. 742-748.

  BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Wajeeha Zia, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laiba Rani, MS CPPT

CONTACT

03498009007; dr.laiba0303@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: May 7, 2026
• Study Start (Estimated): May 10, 2026
• Primary Completion (Estimated): August 2, 2026
• Study Completion (Estimated): August 2, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share