Protocol summary

Summary
Destruction of heart tissue due to decrease of coronary arteries circulation is called myocardial infarction (MI). Because of the importance of bed rest on physiological indices and myocardial oxygen demand determining an appropriate position can prevent side effects in these patients. Therefore, this study would have be done with purpose of determining the effect of body position on physiologic indices including blood pressure, heart rate, respiratory rate, oxygen saturation and electrocardiogram in patient with acute MI. Methodology: In this clinical trial study, 30 patients with acute MI admitted in CCU will be assessed. Physiological indicators and electrocardiogram will be assessed 15 minutes before and after supine, right and left lateral, semi-fowlers and fowlers position. Data collection instruments included questionnaire and check-list, electrocardiogram, pulse oximetry, barometer.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201112248500N1
Registration date: 2012-01-13, 1390/10/23
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-01-13, 1390/10/23
Registrant information
Name
Maryam Banansharifi
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 53 3722 3028
Email address
banansharifi.m@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Gonabad University of Medical Sciences
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2012-04-20, 1391/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of body position on physiological indicators and electrocardiogram in patients with acute myocardial infarction
Public title
Effect of body position on physiological indicators and electrocardiogram in patients with acute myocardial infarction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1- Patients with a diagnosis of myocardial infarction; 2 – the last 12 hours of their infarction. Exclusion criteria: history of thyroid and hormone disorders, diabetes, congestive heart failure, orthostatic hypotension, Cardiogenic shock, anemia, and fever, underlying lung disease, cardiopulmonary resuscitation, old acute myocardial infarction.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Gonabad University of Medical Sciences
Street address
Sidelines of the Asian Highway
City
Gonabad
Postal code
397
Approval date
2011-12-10, 1390/09/19
Ethics committee reference number
8/90

Health conditions studied

1

Description of health condition studied
acute myocard infarction
ICD-10 code
I21
ICD-10 code description
Acute myocardial infarction

Primary outcomes

1

Description
electrocardigram index
Timepoint
15 minutes before and 15 minutes after the changing position
Method of measurement
electrocardiogram

2

Description
physiological index
Timepoint
15 minutes before and 15 minutes after the changing position
Method of measurement
palseoximetry and barometre

Secondary outcomes

empty

Intervention groups

1

Description
َPhysiological indicators and electrocardiogram will be assessed in position which patient first had been met and this position will be assumed as the base position. Then patient will be placed in supine and after 15 minutes all indices will be measured again and patient will be back to basal position. This process will be repeated for right lateral, semi-fowler’s and fowler’s position.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
22 Bahman hospital
Full name of responsible person
Maryam Banan Shariafi
Street address
Naser Khosrow Street
City
Gonabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy of Gonabad University of Medical Sciences
Full name of responsible person
Ali Ekrami
Street address
Sidelines of the Asian Highway
City
Gonabad
Grant name
معاونت پژوهشی
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Gonabad 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
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Maryam Banansharifi
Position
Msc student in Medical Surgical Nursing
Other areas of specialty/work
Street address
Sidelines of the Asian Highway
City
Gonabad
Postal code
397
Phone
+98 53 3722 3028
Fax
+98 3814
Email
banansharifi.m@gmu.ac.ir
Web page address
gmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Maryam Banansharifi
Position
Msc student in Medical Surgical Nursing
Other areas of specialty/work
Street address
Educational and Research Deputy
City
Gonabad
Postal code
397
Phone
+98 53 3722 3028
Fax
+98 3814
Email
banansharifi.m@gmu.ac.ir
Web page address
gmu.ac.ir

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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