Protocol summary

Study aim
Comparison of the Oxyhemoglobin saturation accuracy in pulse oximeters of the fingers, toes, foreheads, and ears in patients undergoing open heart surgery
Design
Trial without control group, before and after, without blindness
Settings and conduct
The present study will be conducted in the intensive care unit. At first, 2 cc of blood is taken from each of the samples through the arterial catheter. The blood samples in a container of ice will be sent immediately to the laboratory. In the form of arterial blood gas analysis, hemoglobin and body temperature are also recorded. Tympanic thermometer is used to determine the patient's temperature. All patients will be in the supine position while the head of the bed is 30 degrees above the body level. To prevent ambient light from interfering with the operation of each of the four types of pulsed oximetry probes, a cover is placed around the probes. The amount of spo2 from four types of the forehead, ear, toe and finger probes will be measured simultaneously by sampling arterial blood gas at a time interval of 0, 1, 2, 3, 4, and 5 minutes. All probes are calibrated before use. The average difference between the amount of sao2 and spo2 and the agreement between them will be calculated using the Bland-Altman analysis. The higher the agreement, the more accurate the probe is.
Participants/Inclusion and exclusion criteria
Open heart surgery patients, lack of left ventricular failure, lack of peripheral vascular disease, lack of renal failure, and temperatures above 35 °C
Intervention groups
The intervention involves the placement of four types of pulsed oximetry probes in the forehead, ear, fingers and toes.
Main outcome variables
arterial oxygen saturation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100913004736N22
Registration date: 2018-03-19, 1396/12/28
Registration timing: retrospective

Last update: 2018-03-19, 1396/12/28
Update count: 0
Registration date
2018-03-19, 1396/12/28
Registrant information
Name
Alireza Khatony
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3827 9394
Email address
akhatony@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-30, 1397/01/10
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
2016-11-21, 1395/09/01
Actual recruitment end date
2017-04-09, 1396/01/20
Trial completion date
empty
Scientific title
Accuracy of pulse oximetry in detection of oxygen saturation in patients admitted to the intensive care unit of heart surgery: comparison of finger, toe, forehead and earlobe probes
Public title
Comparison of pulse oximeter accuracy in determining oxygen saturation
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Have been undergoing open heart surgery Have an arterial line Temperature higher than 35 ° C Hemoglobin greater than 9 g/dl Mean arterial blood pressure above 60 mm Hg PaO2 between 70 to 100% PCo2 less than 45 mm Lack of hematologic problems (anemia, methemoglobinemia, carboxyhemoglobinemia) The absence of left ventricular dysfunction, peripheral vascular disease, acute and chronic renal failure The absence of clubbing fingers No history of smoking The absence of scars, burns, edema, and dressing in place of probing Not receiving medications that affect blood vessel diameter
Exclusion criteria:
Patients requiring suction Patients need to change position
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 67
Actual sample size reached: 67
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
Ethical Committee of Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences, Shahid Beheshty Blvd., Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
62663455667
Approval date
2018-03-14, 1396/12/23
Ethics committee reference number
ir.kums.rec.1396.710

Health conditions studied

1

Description of health condition studied
cardiovascular diseases
ICD-10 code
R94.30
ICD-10 code description
Abnormal result of cardiovascular function study, unspecified

Primary outcomes

1

Description
Percentage of arterial oxygen saturation
Timepoint
At intervals of zero, one, two, three, four, and five minutes
Method of measurement
Using five pulse oximetry probes

Secondary outcomes

1

Description
Arterial oxygen concentration(Pao2)
Timepoint
Once at the beginning of the intervention
Method of measurement
By taking arterial blood sample

Intervention groups

1

Description
The intervention group is the patients undergoing cardiac surgery. At the beginning of the study, the oxygen levels of the arterial blood of all samples will be measured.Then the pulse oximeter probes will be placed in the forehead, ear, throat, fingers, toes, and nose. At intervals of zero, one, two, three, four, and five minutes, the amount of arterial oxygen saturation will be measured by pulse oximeter.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Alireza Khatony
Street address
Imam Ali Hospital, Shahid Beheshty Blvd., Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Phone
+98 83 3836 0295
Email
akhatony@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Blvd., Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Phone
+98 83 3837 6967
Email
farid_n32@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Khatony
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
School of Nursing and Midwifery, Ashayer Ave., Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Phone
+98 83 3827 9394
Email
akhatony@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Khatony
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
School of nursing and midwifery, Ashayer Blvd., Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Phone
+98 988338279394
Email
akhatony@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Khatony
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
School of nursing and midwifery, Ashayer Blvd., Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714634698
Phone
+98 83 3827 9394
Email
akhatony@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
Not applicable
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
Yes - There is 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 main consequence is the possibility of sharing information.
When the data will become available and for how long
Six months after the publication of the article
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
There is no right to extract the article from the documentation.
From where data/document is obtainable
Dr. Alireza Khatony
What processes are involved for a request to access data/document
Within a week of receiving the email, it will be answered.
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