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Development and Evaluation of a Deep Learning-Based Patient Assistant Model after Coronary Artery Bypass Graft Surgery: A Multi-Method Study

Protocol summary

Study aim
Design and evaluation of a combined care package after Coronary Artery Bypass Graft (CABG) Design and evaluation of the performance of a patient assistant model for identifying surgical site infection and performing incentive spirometry based on deep learning after CABG Determine and compare the effectiveness of a combined care package on pulmonary and motor function of patients after CABG in the experimental and control groups Determine and compare the effectiveness of a combined care package on the incidence of surgical site infection in the experimental and control groups
Design
Randomized clinical trial, with control group, with parallel groups, without blinding, randomization in a 1:1 ratio with a computer-generated random number sequence and using a block of four
Settings and conduct
Patients undergoing CABG at Jamaran Hospital will be randomly assigned to the intervention group, who will receive in-person and video training and use a deep learning-based patient assistant model, while the control group will receive only standard postoperative care.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Access and ability to use a deep learning-based model; Willingness and consent to participate in the study; Elective surgery patients; Patients with EF≥ 30% Exclusion criteria: Postoperative complications; infection before discharge; Patients requiring re-surgery or other medical intervention; Kidney failure requiring alternative treatment; Cognitive disorders; Hearing and vision disorders; Severe respiratory disorders; Long-term hospitalization after surgery
Intervention groups
The intervention group uses a deep learning-based patient assistant model and receives in-person and video training, and the control group receives standard post-coronary artery bypass grafting care protocols.
Main outcome variables
6-minute walk test results and incidence of surgical site infection

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221231056998N4
Registration date: 2026-01-27, 1404/11/07
Registration timing: prospective

Last update: 2026-01-27, 1404/11/07
Update count: 0
Registration date
2026-01-27, 1404/11/07
Registrant information
Name
Malihe Sadat Moayed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8755 5503
Email address
msmoayed@bmsu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-03-03, 1404/12/12
Expected recruitment end date
2027-02-01, 1405/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Development and Evaluation of a Deep Learning-Based Patient Assistant Model after Coronary Artery Bypass Graft Surgery: A Multi-Method Study
Public title
valuation of a Deep Learning-Based Patient Assistant Model after Coronary Artery Bypass Graft Surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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%
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 108
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences, Sheikh Bahai street, Vanak Square
City
Tehran
Province
Tehran
Postal code
۱۴۳۵۹۱۵۳۸۱
Approval date
2026-01-12, 1404/10/22
Ethics committee reference number
IR.BMSU.REC.1404.176

Health conditions studied

1

Description of health condition studied
Patients undergoing coronary artery bypass graft surgery
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
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.

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Recipient of standard post-coronary artery bypass grafting care protocols
Category
Rehabilitation

2

Description
Intervention group: User of the deep learning-based patient assistant model and recipient of in-person and video training
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Jamaran hospital
Full name of responsible person
Malihe Sadat Moayed
Street address
Baqiyatallah University of Medical Sciences, Sheikh Bahai street, Vanak Square
City
Tehran
Province
Tehran
Postal code
۱۴۳۵۹۱۵۳۸۱
Phone
+98 21 8862 0880
Email
msmoayed@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Abbas Ali Imani Fooladi
Street address
Baqiyatallah University of Medical Sciences, Shahid Nosrati Alley, South Sheikh Bahai Street,Vanak Square
City
Tehran
Province
Tehran
Postal code
۱۴۳۵۹۱۶۴۷۱
Phone
+98 21 8755 5250
Email
researchcenter@bmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Malihe Sadat Moayed
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Baqiyatallah University of Medical Sciences, Shahid Nosrati Alley, South Sheikh Bahai Street, Vanak Square
City
Tehran
Province
Tehran
Postal code
۱۱۲۲۵۵۸۸۹۹
Phone
+98 21 8862 0880
Email
msmoayed@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Malihe Sadat Moayed
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Baqiyatallah University of Medical Sciences, South Sheikh Bahai Street, Vanak Square
City
Tehran
Province
Tehran
Postal code
۱۱۲۲۵۵۸۸۹۹
Phone
+98 21 8862 0880
Email
msmoayed@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Malihe Sadat Moayed
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Baqiyatallah University of Medical Sciences, South Sheikh Bahai Street, Vanak Square
City
Tehran
Province
Tehran
Postal code
۱۱۲۲۵۵۸۸۹۹
Phone
+98 21 8862 0880
Email
msmoayed@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
De-identified patient demographic information, limited images of categories used in designing the de-identified deep learning model, de-identified study outcome information
When the data will become available and for how long
Accessible after results are printed.
To whom data/document is available
For researchers at academic institutions
Under which criteria data/document could be used
No decision has been made yet.
From where data/document is obtainable
No decision has been made yet.
What processes are involved for a request to access data/document
No decision has been made yet.
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