The effect of oxygen therapy in the basis of blood oxygen saturationlevels monitoring on the heart tissue perfusion in patients with acutemyocardial infarction Hospitalized in the cardiac care unit
Determine the effect of oxygen therapy based on monitoring of arterial oxygen saturation on the status of heart tissue in blood Patients with acute myocardial infarction
Design
This is a clinical trial conducted in parallel in two groups of test and control.
Settings and conduct
This study was performed on patients with acute myocardial infarction admitted to the Cardiac Care Unit of Ziaie Ardakan Hospital.
Participants/Inclusion and exclusion criteria
Entry requirements: Acute myocardial infarction with elevated ST segment; People over 18 years of age who have had more than 12 hours of onset of symptoms of ischemia; No respiratory disease.
Conditions of non-arrival: previous infarction; cardiogenic shock; patient transmission from other departments or hospitals.
Intervention groups
patients will be divided into two groups according to available sampling and simple random assignment in lottery mode.
control group patients, after admission recives oxygen with mask or nasal catheter Based on routine.
But ,the test group, percentage of oxygen saturation will be monitored and if
Less than 90%, Oxygen Therapy will be performed with a simple face mask or nasal catheter.
Main outcome variables
If the results of the study indicate that oxygen can be improved by monitoring SPO2
Heart tissue hemorrhage in patients with STEMI will be used for clinical use.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180321039134N1
Registration date:2018-10-22, 1397/07/30
Registration timing:retrospective
Last update:2018-10-22, 1397/07/30
Update count:0
Registration date
2018-10-22, 1397/07/30
Registrant information
Name
Fatemeh Poorahmadieh ardakan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3223 7096
Email address
F.POORAHMADIEH@SSU.AC.IR
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-08-22, 1397/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oxygen therapy in the basis of blood oxygen saturationlevels monitoring on the heart tissue perfusion in patients with acutemyocardial infarction Hospitalized in the cardiac care unit
Public title
Effect of Oxygen on Myocardial Infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
STEMI
Perad over 15 years of age, more than 12 hours after the onset of symptoms of an ischemic attack
Absence of respiratory illness
Exclusion criteria:
Previous infarction
Cardiogenic shock
Transferring the patient from other departments or hospitals
Cardiac arrest at the time of admission
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients will be divided into two groups according to available sampling and simple random assignment in lottery mode.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of yazd University of Medical Sciences
Street address
Bahonar Square, Central Building of University of Medical Sciences Yazd
City
yazd
Province
Yazd
Postal code
1558738816
Approval date
2018-01-10, 1396/10/20
Ethics committee reference number
ir.ssu.res.1396.168
Health conditions studied
1
Description of health condition studied
Acute myocardial infarction
ICD-10 code
I00–I99
ICD-10 code description
Diseases of the circulatory system
Primary outcomes
1
Description
Measuring Troponin I
Timepoint
Come to study and finish 24 hours and 48 hours after entering the study
Method of measurement
I_chroma device
Secondary outcomes
1
Description
ST segment changes
Timepoint
Admission; End of the first 24 hours; End 48 hours.
Method of measurement
ECG
2
Description
Measurement of creatinine phosphokinase enzyme
Timepoint
At the patient's admission, 12hours later and 24 hours after the initial admission
Method of measurement
BT6400 device
Intervention groups
1
Description
Intervention group: Intervention group: Patients measured by pulse oximetry after the nurse's acceptance of blood oxygen levels. When oxygen saturation in patients is less than 90%, oxygen therapy with a face mask or nasal catheter according to patient selection, by A researcher or researcher assistant will start for the patient until the oxygen arterial blood level reaches 90% or more.
Category
Prevention
2
Description
Control group: Control group: Patients in the control group are those who, after being admitted by the shift nurse, although all the patients undergo cardiac monitoring and controlled by pulse oximetry, control their arterial blood oxygen saturation, they initiate oxygen therapy with a mask or nasal catheter While there may not be a drop in oxygen levels, the oxygen content is between 5 and 7liters per minute.