Protocol summary

Summary
This study aims to effect of supine, semi sitting and lateral positions on results of arterial blood gases and vital signs in coronery artery bypass graft surgery patients. inclusion criteria include: Age18-60 years, intubated Patients and undergoing mechanical ventilation, Fi o2=50%, hemodynamic stability, have intra-arterial line and exclusion criteria include: evidence of chest and spinal trauma, evidence of acute respiratory disease, intake extra liquid, Pump time>120 minute. research population consists of patients hospitalized in open heart surgery intensive care unit of Imam Khomeini Hospital, Ahvaz, who have undergone coronary artery bypass graft surgery. Sample size is 60. in this study, at first, all patients are lying in supine position and after 30 minute the arterial blood sample baseline is collected and vital signs are checked.then the patients are lying in the different positions: semi sitting, right and left lateral respectively for 30 minutes and at the end of period, the amount of 1cc arterial blood gases sample is drawn (in order to arterial blood gases analysis ) and vital signs are recorded before and after the change position.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201202149003N1
Registration date: 2012-06-18, 1391/03/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-06-18, 1391/03/29
Registrant information
Name
Fahimeh Sabeti
Name of organization / entity
Abadan Faculty Medicine
Country
Iran (Islamic Republic of)
Phone
+98 63 1333 3385
Email address
sabetgolpa@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice-Chancellor of Ahvaz University of Medical Sciences and Arvand International Division
Expected recruitment start date
2012-03-05, 1390/12/15
Expected recruitment end date
2012-05-04, 1391/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of supine, semi sitting, and lateral positions on arterial blood gases results and vital signs in patients undergoing coronery artery bypass graft surgery
Public title
The effect of different positions on arterial blood gases results and vital signs in patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age18-60year; intubated Patients and undergoing mechanical ventilation; Fi o2=50%, hemodynamic stability; have intra-arterial line; hemoglobin(HB)>10 g/dl. Exclusion criteria: evidence of chest and spinal trauma; evidence of acute respiratory disease; intake extra liquid; Pump time>120 minute.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapur of Medical Sciences
Street address
Research Vice-Chancellor of Ahvaz Jundishapur University of Medical Sciences, Golestan boulevard , university campus
City
Ahvaz
Postal code
6135715794
Approval date
2012-01-09, 1390/10/19
Ethics committee reference number
358

Health conditions studied

1

Description of health condition studied
CABG
ICD-10 code
I25.9
ICD-10 code description
ischaemic heart disease (chronic)

Primary outcomes

1

Description
Arterial blood gases results
Timepoint
After each change position(30 minute)
Method of measurement
Arterial blood gases analyzer( premier 3000(American)series machines-Radiometer)

2

Description
Vital signs
Timepoint
After each change position(30 minute)
Method of measurement
Recording of vital signs on monitor.Temperature using tympanic digital thermometer

Secondary outcomes

1

Description
Age
Timepoint
Before intervention
Method of measurement
Recording of information in patient document

2

Description
Sex
Timepoint
Befoe intervention
Method of measurement
Observation

Intervention groups

1

Description
patients are lying in supine position and after 30 minute the arterial blood sample is collected and vital signs are checked.
Category
Treatment - Other

2

Description
patients are lying in semi siting position and after 30 minute the arterial blood sample is collected and vital signs are checked.
Category
Treatment - Other

3

Description
patients are lying in right lateral position and after 30 minute the arterial blood sample is collected and vital signs are checked.
Category
Treatment - Other

4

Description
patients are lying in left lateral position and after 30 minute the arterial blood sample is collected and vital signs are checked.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Imam Khomeini Hospital
Full name of responsible person
Tayebeh Mahvar
Street address
Ahvaz Imam Khomeini Hospital, Azadegan Street,Ahvaz
City
kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Vice-Chancellor of Ahvaz Jundishapur University of Medical Scienses
Full name of responsible person
Dr Mostafa Feghhi
Street address
Research Vice-Chancellor of Ahvaz Jundishapur University of Medical Sciences, Golestan boulevard , university campus
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice-Chancellor of Ahvaz Jundishapur University of Medical Scienses
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Arvand International Division, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Mohammad-Jafar Yadyad
Street address
Arvand International Division, International Airport, Abadan
City
Abadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arvand International Division, Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
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
Abadan Faculty of Medicine
Full name of responsible person
Fahimeh Sabeti
Position
Faculty Member, MS
Other areas of specialty/work
Street address
Abadan Faculty of Medicine,Taleghani Hospital,Abadan
City
Abadan
Postal code
صندوق پستی 517
Phone
+98 63 1333 3385
Fax
+98 63 1333 5363
Email
sabetifa@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Abadan Faculty of Medicine
Full name of responsible person
Fahimeh Sabeti
Position
Faculty Member, MS
Other areas of specialty/work
Street address
Abadan Faculty of Medicine, Taleghani Hospital, Abadan
City
Abadan
Postal code
Post Box 517
Phone
+98 63 1333 3385
Fax
+98 63 1333 5363
Email
sabetifa@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Abadan Faculty of Medicine
Full name of responsible person
Fahimeh Sabeti
Position
Faculty Member, MS
Other areas of specialty/work
Street address
Abadan Faculty of Medicine,Taleghani Hospital, Abadan
City
Abadan
Postal code
Post Box 517
Phone
+98 63 1333 3385
Fax
+98 63 1333 5363
Email
sabetifa@yahoo.com
Web page address

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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