AzTrials
AzTrials

CABGCABGNCT07574411

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

A study testing IMT Threshold device in people with CABG, run by Riphah International University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 70 years
Conditions the study is for
CABG
What is being tested?
IMT Threshold device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
No sites listed yet
Study dates
10 May 2026to 2 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 .

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Laiba Rani, MS CPPT contact

03498009007

dr.laiba0303@gmail.com

About this study

Official title: Effects of E-care Protocol in Length of Hospital Stay and Respiratory Failure in Patients With Coronary Artery Bypass Graft

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.

Conditions
CABG
Being tested
IMT Threshold device
Keywords
CAD, CABG, E CARE protocol, RESPIRATORY FAILURE
Medical subject headings
Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMT Threshold deviceDevice

    Also called Ankle pump, Bed pedal exercise

    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

Study groups in NCT07574411
Study groupRoleWhat they receive
Group BActive comparatorNot described
Receives: Device: IMT Threshold device
Group ANo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in Length of stay

    Length of stay in ward will be noted

    Measured: Total days 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2026
  2. Study start10 May 2026 (estimated)
  3. Primary completion2 Aug 2026 (estimated)
  4. Study completion2 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07574411
Sponsor's protocol ID
Laiba rani
Other IDs
64146
Acronym
CABG
Status last verified
May 2026
First submitted
23 Feb 2026
Last updated
7 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing IMT Threshold device in people with CABG, run by Riphah International University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Laiba Rani, MS CPPT (03498009007, dr.laiba0303@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in Length of stay (time frame: Total days 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07574411, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

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