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Not yet recruitingNCT07574411CABGUpdated May 7, 2026

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

An interventional study of IMT Threshold device in CABG, sponsored by Riphah International University. Not yet recruiting. Open to participants aged 45 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-07.

Sponsored by Riphah International University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
45 Years to 70 Years
Sex
All
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Study 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.

Read the detailed description

The study will be randomized clinical trial. It will be conducted at Gulab Devi Chest Hospital Lahore, Pakistan. Total sample size will be 42. Attrition rate is 10%. The data will be analyzed using SPSS v25. Sample size will be conducted via non probability consecutive sampling technique as per inclusion criteria participants will be randomly assigned into two groups. 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. Group B will receive E- CARE protocol with IMT threshold device to improve respiratory muscle strength. This study focuses on the LOHS and the incidence of respiratory failure.

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Conditions studied

  • CABG

Keywords

  • CAD
  • CABG
  • E CARE protocol
  • RESPIRATORY FAILURE
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In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's planned enrollment of 42 is below the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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 .

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
42 participants (estimated)

Study arms

  • Active comparator
    Group B

    Device: IMT Threshold device

  • No intervention
    Group A

Interventions

  • DeviceIMT Threshold 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

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What researchers measure

Primary outcomes

  1. change in Length of stay

    Length of stay in ward will be noted

    Time frame: Total days 7

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Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Maisel WH, Rawn JD, Stevenson WG. Atrial fibrillation after cardiac surgery. Ann Intern Med. 2001 Dec 18;135(12):1061-73. doi: 10.7326/0003-4819-135-12-200112180-00010. PubMed 11747385 ↗
  • Rajaei S, Dabbagh A. Risk factors for postoperative respiratory mortality and morbidity in patients undergoing coronary artery bypass grafting. Anesth Pain Med. 2012 Fall;2(2):60-5. doi: 10.5812/aapm.5228. Epub 2012 Sep 13. PubMed 24223339 ↗
  • Deb S, Wijeysundera HC, Ko DT, Tsubota H, Hill S, Fremes SE. Coronary artery bypass graft surgery vs percutaneous interventions in coronary revascularization: a systematic review. JAMA. 2013 Nov 20;310(19):2086-95. doi: 10.1001/jama.2013.281718. PubMed 24240936 ↗
  • 11. Kazem, S.S., et al., Pulmonary physiotherapy effect on patients undergoing open cardiac surgery. Russian open medical journal, 2014. 3(3): p. 306.
  • Head SJ, Milojevic M, Daemen J, Ahn JM, Boersma E, Christiansen EH, Domanski MJ, Farkouh ME, Flather M, Fuster V, Hlatky MA, Holm NR, Hueb WA, Kamalesh M, Kim YH, Makikallio T, Mohr FW, Papageorgiou G, Park SJ, Rodriguez AE, Sabik JF 3rd, Stables RH, Stone GW, Serruys PW, Kappetein AP. Stroke Rates Following Surgical Versus Percutaneous Coronary Revascularization. J Am Coll Cardiol. 2018 Jul 24;72(4):386-398. doi: 10.1016/j.jacc.2018.04.071. PubMed 30025574 ↗
  • Zanini M, Nery RM, de Lima JB, Buhler RP, da Silveira AD, Stein R. Effects of Different Rehabilitation Protocols in Inpatient Cardiac Rehabilitation After Coronary Artery Bypass Graft Surgery: A RANDOMIZED CLINICAL TRIAL. J Cardiopulm Rehabil Prev. 2019 Nov;39(6):E19-E25. doi: 10.1097/HCR.0000000000000431. PubMed 31343586 ↗
  • Tajti P, Karmpaliotis D, Alaswad K, Jaffer FA, Yeh RW, Patel M, Mahmud E, Choi JW, Burke MN, Doing AH, Dattilo P, Toma C, Smith AJC, Uretsky B, Holper E, Potluri S, Wyman RM, Kandzari DE, Garcia S, Krestyaninov O, Khelimskii D, Koutouzis M, Tsiafoutis I, Jaber W, Samady H, Moses JW, Lembo NJ, Parikh M, Kirtane AJ, Ali ZA, Doshi D, Xenogiannis I, Stanberry LI, Rangan BV, Ungi I, Banerjee S, Brilakis ES. In-Hospital Outcomes of Chronic Total Occlusion Percutaneous Coronary Interventions in Patients With Prior Coronary Artery Bypass Graft Surgery. Circ Cardiovasc Interv. 2019 Mar;12(3):e007338. doi: 10.1161/CIRCINTERVENTIONS.118.007338. PubMed 30871357 ↗
  • Writing Committee Members; Lawton JS, Tamis-Holland JE, Bangalore S, Bates ER, Beckie TM, Bischoff JM, Bittl JA, Cohen MG, DiMaio JM, Don CW, Fremes SE, Gaudino MF, Goldberger ZD, Grant MC, Jaswal JB, Kurlansky PA, Mehran R, Metkus TS Jr, Nnacheta LC, Rao SV, Sellke FW, Sharma G, Yong CM, Zwischenberger BA. 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. J Am Coll Cardiol. 2022 Jan 18;79(2):197-215. doi: 10.1016/j.jacc.2021.09.005. Epub 2021 Dec 9. PubMed 34895951 ↗
  • Zhang S, Li B, Meng X, Zuo H, Hu D. The Effects of Inspiratory Muscle Training (IMT) on Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery: A Systematic Review and Meta-Analysis. Rev Cardiovasc Med. 2023 Jan 9;24(1):16. doi: 10.31083/j.rcm2401016. eCollection 2023 Jan. PubMed 39076880 ↗
  • Hochman JS, Anthopolos R, Reynolds HR, Bangalore S, Xu Y, O'Brien SM, Mavromichalis S, Chang M, Contreras A, Rosenberg Y, Kirby R, Bhargava B, Senior R, Banfield A, Goodman SG, Lopes RD, Pracon R, Lopez-Sendon J, Maggioni AP, Newman JD, Berger JS, Sidhu MS, White HD, Troxel AB, Harrington RA, Boden WE, Stone GW, Mark DB, Spertus JA, Maron DJ; ISCHEMIA-EXTEND Research Group. Survival After Invasive or Conservative Management of Stable Coronary Disease. Circulation. 2023 Jan 3;147(1):8-19. doi: 10.1161/CIRCULATIONAHA.122.062714. Epub 2022 Nov 6. PubMed 36335918 ↗
  • Fernandes GC, Kovacs R, Abbott JD, Subacius H, Dyal MD, Goldberger JJ; Outcomes of Beta-Blocker Therapy After Myocardial Infarction (OBTAIN) Investigators. Determinants of Early and Late In-Hospital Mortality After Acute Myocardial Infarction: A Subanalysis of the OBTAIN Registry. Can J Cardiol. 2023 Apr;39(4):531-537. doi: 10.1016/j.cjca.2022.10.019. Epub 2022 Oct 21. PubMed 36273724 ↗
  • Redfors B, Stone GW, Alexander JH, Bates ER, Bhatt DL, Biondi-Zoccai G, Caldonazo T, Farkouh M, Rahouma M, Puskas J, Sandner S, Gaudino MFL. Outcomes According to Coronary Revascularization Modality in the ISCHEMIA Trial. J Am Coll Cardiol. 2024 Feb 6;83(5):549-558. doi: 10.1016/j.jacc.2023.11.002. Epub 2023 Nov 11. PubMed 37956961 ↗
  • Araujo CO, Araujo Alves CC, Dos Santos FRA, Cahalin LP, Cipriano GFB, Cipriano G. Inspiratory Muscle Training in Phase 1 and 2 Postoperative Cardiac Rehabilitation Following Coronary Artery Bypass Graft Surgery: Systematic Review With Meta-Analysis. Phys Ther. 2024 Jul 2;104(7):pzae061. doi: 10.1093/ptj/pzae061. PubMed 38624192 ↗
  • Yang Q, Wang L, Zhang X, Lu P, Pan D, Li S, Ling Y, Zhi X, Xia L, Zhu Y, Chen Y, Liu C, Jin W, Reinhardt JD, Wang X, Zheng 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 Pulm Med. 2024 Oct 14;24(1):512. doi: 10.1186/s12890-024-03286-1. PubMed 39402537 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07574411
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
May 7, 2026
Start date
May 10, 2026 (estimated)
Primary completion
Aug 2, 2026 (estimated)
Completion
Aug 2, 2026 (estimated)
Last update
May 7, 2026

Study contacts

Laiba Rani, MS CPPT
Contact
dr.laiba0303@gmail.com
03498009007
Wajeeha Zia, PhD
principal investigator · Riphah International University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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