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IRCT20200901048576N1 IRCT 2021-03-15 Zahedan University of Medical Sciences The Effect of Oxygen Therapy in Acute Myocardial Infraction Electro Cardio Gram=ECG/Acute Myocardial Infraction=AMI Comparison of The Effect of Taking Oxygen with Not Taking Oxygen in the Prognosis of Patients with Acute Myocardial Infarction 2019-03-25 anticipated 50 Complete https://irct.ir/trial/50628 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: NA, 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. 3 Acute myocardial infarction. Intervention 1: 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. Intervention 2: Control group: A total of 25 people are selected to receive oxygen existing at the room without any intervention. Yes - There is a plan to make this available What will be shared: 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 be available six months after publishing the first draft of data analysis and results in national and international journals and conferences. To whom: All sorts of findings and data analyses for future academic and industrial researchers. Conditions: 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. Where to obtain: They should be in touch with Mahsa Zeiasaeidi as chief investigator of this research via mahsa.zsd@zaums.ac.ir. How to obtain: 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. Comments:
public Mahsa Zeiaesaeidi
Level 1, Unit 3, No. 59, Daneshgah Ave., Zahedan
Zahedan Iran (Islamic Republic of) 5719563918 +98 54 3344 4304 mahsa.zsd@zaums.ac.ir Zahedan University of Medical Sciences scientific Mahsa Zeiaesaeidi
Level 1, Unit 3, No. 59, Daneshgah Ave., Zahedan
Zahedan Iran (Islamic Republic of) 5719563918 +98 54 3344 4304 mahsa.zsd@zaums.ac.ir Zahedan University of Medical Sciences Iran (Islamic Republic of) 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 30 years no limit Both 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 . N/A N/A 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. Control group: A total of 25 people are selected to receive oxygen existing at the room without any intervention. 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. 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. 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). 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). Zahedan University of Medical Sciences Approved 2019-02-04 Ethics committee of Zahedan University of Medical Sciences ZAUMS Main campus, Zahedan, Sistan and Baluchestan, Iran Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)