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The effect of planned mobilization on indexes of care improvement in patient undergoing coronary artery bypass surgery, Jamaran heart hospital, 2013

Protocol summary

Summary
The aim of this Study was to Assess the effect of planned mobilization on indexes of Care improvement in patients undergoing cardiac Surgery .This study is a randomized controlled clinical trial in patients undergoing coronary artery bypass surgery. A total number of 100 patients who had inclusion criteria ( stable hemodynamic; fully consciousness; and limited drainage), for this study were randomly assigned in control and Exprimental groups. After obtaining the written informed consent from all patients, the patient in experimental group, were trained about the benefits of faster mobilization and complications of long-term effects of inactivity. After transferring the patient from the operating room to the intensive care unit and extubation, patients who were fully alert, hemodynamically stable without inotropic support, and had respiratory stable condition and limited drainage, the intervention was carried out. In the first day the program was consisted of sitting at the edge of the bed, stand and then walk 10 meters in the morning and afternoon of the second day, and followed by thirty meters walking in the third day two times (morning and evening). In the control group we had no intervention and patients received their routine care and were mobilized in the third post operation day, after drain removal. Then patients were compared based on care improvement indexes such as atelectasis, pleural effusion, and hospital stay. chest x ray was interpreted by a anesthesiologist who were blind to the patients allocation in groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201309176778N2
Registration date: 2013-10-11, 1392/07/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-10-11, 1392/07/19
Registrant information
Name
Seyed Tayeb Moradian Vafaei
Name of organization / entity
School of nursing and midwifery, Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2303 4258
Email address
t-moradian@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Baghiyattallah university of medical sciences, Nursing faculty
Expected recruitment start date
2013-05-24, 1392/03/03
Expected recruitment end date
2013-09-29, 1392/07/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of planned mobilization on indexes of care improvement in patient undergoing coronary artery bypass surgery, Jamaran heart hospital, 2013
Public title
The effect of planned mobilization on indexes of care improvement in patient undergoing heart surgery
Purpose
Prevention
Inclusion/Exclusion criteria
(Inclusion criteria: Patient with no history of chronic obstructive pulmonary disease; patients without mobility problems; patients without neurological problems; lack of concurrent surgery) (Exclusion criteria: severe unstable hemodynamic; Drainage more than 150 cc per hour)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Nursing faculty ethic commetee
Street address
nursing faculty, Baghyattallah university of medical sciences, Tehran
City
Tehran
Postal code
Approval date
2013-05-12, 1392/02/22
Ethics committee reference number
1

Health conditions studied

1

Description of health condition studied
Atelectasis
ICD-10 code
j98.1
ICD-10 code description
Collapse of lung

Primary outcomes

1

Description
Atelectasis
Timepoint
First, second and third day after surgery
Method of measurement
Chest X ray

Secondary outcomes

1

Description
Hospital stay
Timepoint
Discharge day
Method of measurement
Reffer to patients medical document

Intervention groups

1

Description
After obtaining the written informed consent from all patients, the patient in experimental group, were trained about the benefits of faster mobilization and complications of long-term inactivity. After transferring the patient from the operating room to the intensive care unit and extubation, in patients who were fully alert, hemodynamically stable without inotropic support, and had respiratory stable condition and limited drainage, the intervention was carried out. In the first day the program was consisted of sitting at the edge of the bed, stand and then walk 10 meters in the morning and afternoon of the second day, and followed by thirty meters walking in the third day two times (morning and evening).
Category
Prevention

2

Description
In the control group we don't have any intervention. they will receive the routine hospital care. in these patients mobilization will be done in the third post operation day after removing the chest tubes.routine care. As part of the process, leaving them flat on the third day after the operation is performed by removing the drain location.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Jamaran heart hospital
Full name of responsible person
Dr Mohammad Saeid Ghiasi
Street address
Jamaran Heart Hospital, Jamaran Street, Niavaran Street, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Nursing faculty, Baghiyatallah University of medical sciences
Full name of responsible person
Dr Abbas Ebbadi
Street address
Baghiyatallah University of medical sciences, Sheykh Bahaei street, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nursing faculty, Baghiyatallah University of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nursing Faculty, Baghiyyatallah university of medical sciences
Full name of responsible person
Seyed Tayeb Moradian
Position
Faculty Member
Other areas of specialty/work
Street address
Nursing Faculty, Baghiyyatallah university of medical sciences
City
Tehran
Postal code
Phone
+98 21 2228 6057
Fax
Email
t-moradian@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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