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IRCT20221231056998N4 IRCT 2026-01-27 Bagheiat-allah University of Medical Sciences valuation of a Deep Learning-Based Patient Assistant Model after Coronary Artery Bypass Graft Surgery Development and Evaluation of a Deep Learning-Based Patient Assistant Model after Coronary Artery Bypass Graft Surgery: A Multi-Method Study 2026-03-03 anticipated 108 Recruiting https://irct.ir/trial/88768 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients are assigned in a 1:1 ratio to one of the experimental (B) and control (A) groups using a computer-generated random number sequence using a block of four. Given the block size of four, there will be a total of six blocks as AABB, ABAB, ABBA, BBAA, BABA, BAAB. After the blocks are numbered, each block is used for four patients. In this case, if block number one is randomly selected, the first patient will be in group A, the second patient in group A, the third patient in group B, and the fourth patient in group B. For the fifth patient, one of the blocks is randomly selected again, and the fifth to eighth patients will be assigned to group A or B, respectively. This method will continue until the desired sample size is reached. N/A Patients undergoing coronary artery bypass graft surgery. Intervention 1: Control group: Recipient of standard post-coronary artery bypass grafting care protocols. Intervention 2: Intervention group: User of the deep learning-based patient assistant model and recipient of in-person and video training. Yes - There is a plan to make this available What will be shared: De-identified patient demographic information, limited images of categories used in designing the de-identified deep learning model, de-identified study outcome information When: Accessible after results are printed. To whom: For researchers at academic institutions Conditions: No decision has been made yet. Where to obtain: No decision has been made yet. How to obtain: No decision has been made yet. Comments:
public Malihe Sadat Moayed
Baqiyatallah University of Medical Sciences, Shahid Nosrati Alley, South Sheikh Bahai Street, Vanak Square
Tehran Iran (Islamic Republic of) ۱۱۲۲۵۵۸۸۹۹ +98 21 8862 0880 msmoayed@yahoo.com Bagheiat-allah University of Medical Sciences scientific Malihe Sadat Moayed
Baqiyatallah University of Medical Sciences, South Sheikh Bahai Street, Vanak Square
Tehran Iran (Islamic Republic of) ۱۱۲۲۵۵۸۸۹۹ +98 21 8862 0880 msmoayed@yahoo.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Access and ability to use a deep learning-based model Willingness and consent to participate in the study Age over 18 Elective surgery patients Patients with EF ≥ 30% 18 years no limit Both Rehabilitation Rehabilitation Control group: Recipient of standard post-coronary artery bypass grafting care protocols Intervention group: User of the deep learning-based patient assistant model and recipient of in-person and video training Effectiveness of the combined care package after coronary artery bypass graft surgery by measuring the outcomes of blood oxygen saturation, heart rate, distance traveled by the patient to assess pulmonary and motor function measured using the 6-minute walk test and the outcome of the incidence of surgical site infection checked with the SSI checklist recommended by CDC. Timepoint: The 6MWT will be used to evaluate the effect of the combined care package on the patients' pulmonary and motor function. After 30 days, the researcher will be present at the doctor's visit at the clinic and will perform a 6-minute walk test for both intervention and control groups. In this test, patients must walk along a specified 30-meter corridor. Before starting the test, the instructions for the test are explained to the patients, and the heart rate and oxygen saturation percentage of the patients are measured by the researcher with a pulse oximeter. Patients can rest if necessary, but they will start walking again as soon as they are able. Then, after 6 minutes, the distance covered by the patient, heart rate, and oxygen saturation percentage will be recorded. Finally, the results of the 6MWT will be compared in the two groups. The evaluation of the effect of the combined care package on the incidence of infection will be performed using the SSI checklist recommended by the CDC. At the patient's first visit (approximately two weeks after surgery), the researcher will examine and judge the wound status through a checklist that includes items such as local pain or tenderness, local swelling in the wound area, redness or warmth in the wound area, purulent drainage, spontaneous separation of the wound edges, opening or aspiration as determined by the surgeon, and microbial growth in the culture sample if requested by the physician. The results of the wound examination in the two groups will be compared. Method of measurement: Before and after the 6-minute walk test, the heart rate and oxygen saturation of the patients will be measured by the researcher with a pulse oximetry device. The distance traveled will be measured using a meter and corridor markings. The incidence of infection will be assessed using the SSI checklist recommended by the CDC. Bagheiat-allah University of Medical Sciences Approved 2026-01-12 Research Ethics Committees of Baqiyatallah University of Medical Sciences Baqiyatallah University of Medical Sciences, Sheikh Bahai street, Vanak Square Tehran Tehran Iran (Islamic Republic of)