The main aim is to compare the effect of oxygen with non-oxygen on the prognosis of patients with acute myocardial infarction.
Design
In this project, a randomized trial will be performed based on the evaluation of supplemental oxygen versus air in patients with AMI who were not initially hypoxic. This random sampling will be done from a computer catalogue using an online random model. Oxygen saturation is recorded at the beginning and end of treatment.
Settings and conduct
The study areas are all Zahedan educational hospitals. The study includes patients aged 30 years or older who came to the emergency or cardiac intensive care by ambulance or by themself.
During this research, evaluations are provided to the research team without the information of the study group. Descriptive statistics are used to describe the data, standard deviation, frequency and percentage. The comparison and difference between the results of oxygen therapy in patients with myocardial infarction are determined by chi-square test. The T-test is used to compare the average time of patients' hospitalizations. The p-value (>0.05) is considered to show the statistical difference. All analyses are performed with SPSS software.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- Patients who have symptoms suggestive of MI
- ECG changes with elevated cardiac troponin
- Oxygen saturation of 90% or higher on pulse oximetry
Exclusion criteria:
- Patients who have continuous oxygen therapy
- Patients who have suffered cardiac arrest prior to inclusion
- If supplemental oxygen therapy is started before evaluation for inclusion for less than 20 minutes
Intervention groups
Patients are randomly selected to receive oxygen through an oral mask (6 litres per minute for the next 6 to 12 hours) or room air.
Main outcome variables
Effect of supplemental oxygen versus air in patients with AMI
Comparison of The Effect of Taking Oxygen with Not Taking Oxygen in the Prognosis of Patients with Acute Myocardial Infarction
Public title
The Effect of Oxygen Therapy in Acute Myocardial Infraction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who present to emergency department Zahedan University Hospital
Patients who have symptoms suggestive of MI
ECG changes with elevated cardiac troponin
Oxygen saturation of 90% or higher on pulse oximetry
Patients who have Iranian nationality
Patients who orally are agreed to participate and have signed consent forms
Exclusion criteria:
Patients who have continuous oxygen therapy
Patients who have suffered cardiac arrest prior to inclusion
If supplemental oxygen therapy is started before evaluation for inclusion for less than 20 minutes, new evaluation can take place after discontinuation of oxygen delivery and ten minutes of wash-out .
Age
From 30 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In this method, based on the sample size, we will prepare a number of envelopes whose contents are not known at all, and then on the cards, random sequences that have been generated online through the randomization website for random allocation. We put them in envelopes.
Now the concealment must be done on the method used to execute the random sequence on the participants. So that before the assignment of each person, his / her assigned group is not known.
Without this, there is a possibility of disclosing the sequences, which will weaken the research. On the other hand, it can lead to the elimination of certain patients based on their prognosis, or patients with better conditions enter the intervention group and patients with worse conditions. Be the control group and cause the selection bias in the study as a whole.
Therefore, it is necessary to make a decision to participate or reject the study from the beginning and fill in the informed consent forms and then the participants are randomly assigned to each group.
In the implementation of the random allocation process, what is important is the person who performs this process, who should not be in other stages of this research and should be separate from other researchers in order to reduce possible bias.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
NA
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
ZAUMS Main campus, Zahedan, Sistan and Baluchestan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2019-02-04, 1397/11/15
Ethics committee reference number
IR.ZAUMS.REC.1397.430
Health conditions studied
1
Description of health condition studied
Acute myocardial infarction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The mortality rate of people who were diagnosed by MI and have been treated with oxygen
Timepoint
During one and three months after oxygen therapy
Method of measurement
Number of patients who died or survived during follow-up
2
Description
The mortality rate in people with acute MI without receiving oxygen
Timepoint
During one and three months after oxygen therapy
Method of measurement
Number of patients who died or survived during follow-up
3
Description
The rate of re-hospitalization of people due to acute MI with receiving oxygen
Timepoint
During one and three months after oxygen therapy
Method of measurement
Re-hospitalization (measured by the number of patients who have been re-admitted for three months)
4
Description
The rate of re-hospitalization of people due to acute MI without receiving oxygen
Timepoint
During one and three months after oxygen therapy
Method of measurement
Re-hospitalization (measured by the number of patients who have been re-admitted for three months)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 25 people are randomly selected to receive oxygen through an oral mask at 6 litres per minute during the 6 to 12 hours of emergency hospitalization.
Category
N/A
2
Description
Control group: A total of 25 people are selected to receive oxygen existing at the room without any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Hospital/Imam Ali Research Hospital
Full name of responsible person
Mahsa Zeiaesaeidi
Street address
Khatam Hospital, Jame Jam Blvd, Zahedan, Sistan and Baluchestan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
009815733169
Phone
+98 54 3322 0501
Email
khatamhospital_zah@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Prof. Nourmohammad Bakhshani
Street address
ZAUMS Main campus, Zahedan, Sistan and Baluchestan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2116
Email
zaums.research@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Mahsa Zeiaesaeidi
Position
Physicians assistant
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Level 1, Unit 3, No. 59, Daneshgah Ave., Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
5719563918
Phone
+98 54 3344 4304
Email
mahsa.zsd@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahsa Zeiaesaeidi
Position
Physicians assistant
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Level 1, Unit 3, No. 59, Daneshgah Ave., Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
5719563918
Phone
+98 54 3344 4304
Email
mahsa.zsd@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahsa Zeiaesaeidi
Position
Physicians assistant
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Level 1, Unit 3, No. 59, Daneshgah Ave., Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
5719563918
Phone
+98 54 3344 4304
Email
mahsa.zsd@zaums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All types of data (related to changes of oxygen therapy in acute myocardial infarction) will be published as anonymous for each planned publication.
When the data will become available and for how long
The data will be available six months after publishing the first draft of data analysis and results in national and international journals and conferences.
To whom data/document is available
All sorts of findings and data analyses for future academic and industrial researchers.
Under which criteria data/document could be used
It may be necessary to use these research findings to write-up future research on this topic. Therefore, by maintaining the anonymity of the patients, the findings are available for other researchers.
From where data/document is obtainable
They should be in touch with Mahsa Zeiasaeidi as chief investigator of this research via mahsa.zsd@zaums.ac.ir.
What processes are involved for a request to access data/document
There is a need to contact Mahsa Zeiasaeidi (chief investigator of this research) via email. She will share all available data to the inquirer within less than six months.