Determining the Effect of Implementing the Early Movement Protocol on the amount of Postoperative Bleeding in patients undergoing Open Heart Surgery
Design
A clinical trial with a control group will be conducted on 92 patients with non-random allocation.
Settings and conduct
In the ICU Open Heart department of Imam Ali Hospital in Zahedan, patients after Open Heart Surgery will be brought from the patient's bed during the second day to implement the patient movement protocol, The patients will not know whether they will be in the intervention or control group.
Participants/Inclusion and exclusion criteria
Patients undergoing open heart surgery, With entry criteria including the Age range of 18 to 100 years, Getting a score of 19 and below from the Bleeding prediction questionnaire after Open Heart Surgery (people who will have moderate and severe risk), definite diagnosis The need for Open Heart Surgery, Undergoing CABG Heart Surgery, The ability to move (not having a disability or specific movement restriction after the operation), Extubation after 18 hours after the operation, Elective and non-emergency open heart surgery ؛ the conditions of not Entry into the study includes getting a score of 20 or higher on the Postoperative Bleeding questionnaire in Open Heart Surgery patients, Having an uncorrected coagulation disorder, Having a specific restriction of movement after the operation, Having severe uncontrollable bleeding, Stable Lack of hemodynamic status after surgery, Mechanical ventilation for more than 48 hours
Intervention groups
For the people in the intervention group, The Early Movement Protocol will be implemented so that they will be taken out of bed on the second day after the operation. The people of the control group will be taken out of bed according to the ward routine on the third day.
Main outcome variables
Blood drainage rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231120060120N2
Registration date:2024-02-10, 1402/11/21
Registration timing:prospective
Last update:2024-02-10, 1402/11/21
Update count:0
Registration date
2024-02-10, 1402/11/21
Registrant information
Name
Mahla Dahmardeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3348 6610
Email address
mahla.dahmardeh.nurse1999@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-19, 1402/12/29
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Implementing the Early Movement Protocol on the amount of Postoperative Bleeding in patients undergoing Open Heart Surgery
Public title
Effect of Implementing the Early Movement Protocol on the amount of Postoperative Bleeding
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range from 18 to 100 years
Getting a score of 19 and below from the bleeding prediction questionnaire after open heart surgery (people who will have moderate and severe risk)
Definitive diagnosis of the need for open heart surgery
Undergoing CABG heart surgery
The ability to move (not having a disability or restriction of specific movement after the operation)
Extubation from 18 hours after the operation
Elective and non-emergency open heart surgery
Exclusion criteria:
Getting a score of 20 or higher from the postoperative bleeding questionnaire in open heart surgery patients
Having an uncorrected coagulation disorder
Having a specific restriction of movement after the operation
Having uncontrollable heavy bleeding
Having severe changes in hemodynamic status
Unstable hemodynamic status after surgery
Mechanical ventilation for more than 48 hours
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher will be present at the bedside of the patients, will explain to them the purpose of the study, and the informed consent form will be completed by the patients to participate in the study, but the people in the intervention and control groups will not know which group they will be in. Both groups will receive routine ward care. That is, they will be taken out of bed on the third day after the operation. The people of the intervention group will be taken out of bed on the second day to move, but they will not know that they will be part of the intervention group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Dr. Hasabi Square, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816113876
Approval date
2023-12-24, 1402/10/03
Ethics committee reference number
IR.ZAUMS.REC.1402.391
Health conditions studied
1
Description of health condition studied
Open Heart Surgery
ICD-10 code
T82.0
ICD-10 code description
Mechanical complication of heart valve prosthesis
Primary outcomes
1
Description
Bleeding volume measured in Bottle Chest
Timepoint
The first, Second and Third days after Open Heart Surgery
Method of measurement
Blood volume and drainage measured in Bottle Chest
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: On the second day after open heart surgery, they will be taken out of bed to perform the movement protocol. Early movement will be done in such a way that first the patient will be placed in the bed in a semi-sitting position, he will be in this condition for 15 minutes, then he will return to the lying position. After one hour in bed, he will be in a sitting position, he will be in this position for 15 minutes, then he will return to the lying position. An hour later, he will be placed on the edge of the bed with his legs hanging for 15 minutes, then he will return to the lying position, after an hour he will sit on the side of the bed for 15 minutes and return to the bed again. An hour later, he will walk a few steps next to the bed and return to the bed again. All steps will be according to the patient's tolerance.
Category
Other
2
Description
Control group: On the third day, according to the department's routine, they will be taken out of bed to implement the movement protocol
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital, Zahedan University of Medical Sciences
Full name of responsible person
Mahla Dahmardeh
Street address
Dr. Hasabi Square, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816113876
Phone
+98 993 706 8022
Email
Mahla.dahmardeh.nurse1999@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohsen Taheri
Street address
Dr. Hasabi Square, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816113876
Phone
+98 54 3348 6610
Email
info@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
80
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
Zahedan University of Medical Sciences
Full name of responsible person
Mahla Dahmardeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Dr. Hasabi Square, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816113876
Phone
+98 54 3348 6610
Email
mahla.dahmardeh.nurse1999@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahla Dahmardeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Dr. Hasabi Square, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816113876
Phone
+98 54 3348 6610
Email
mahla.dahmardeh.nurse1999@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahla Dahmardeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Dr. Hasabi Square, Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816113876
Phone
+98 54 3348 6610
Email
mahla.dahmardeh.nurse1999@gmail.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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data will be analyzed and the results will be presented in the article.
When the data will become available and for how long
Since 2024
To whom data/document is available
The data will be presented in the form of results in the article and researchers can access it
Under which criteria data/document could be used
The data will be presented in the form of results in the article and researchers can access it
From where data/document is obtainable
By sending an email to Mehla Dehmardeh, mahla.dahmardeh.nurse1999@gmail.com
What processes are involved for a request to access data/document