This is a triple-blind clinical trial that will be performed to evaluate the effects of supplemental oxygen on some clinical outcomes (consumption of analgesics, cardiac dysrhythmias, recurrence of chest pain and readmission) in patients with non ST elevation acute coronary syndrome in Bushehr Heart Center. Seventy patients with non ST-segment elevation acute coronary syndromes who have arterial oxygen saturation greater than 90 percent will be selected with purposive sampling and will be randomly divided into intervention (supplemental oxygen) and placebo (room air) groups. Patients in the intervention group will receive 4-6 liters per minute of oxygen by nasal cannula for up to 6 hours after admission. Patients in the control group will receive the same amount of air with the same way. The incidence of cardiac dysrhythmias in the first 24 hours, the frequency of chest pain and analgesic consumption in second day, and readmission in the first 30 days will be checked.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014081118768N1
Registration date:2014-11-24, 1393/09/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-11-24, 1393/09/03
Registrant information
Name
Fatemeh Heidari
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3501
Email address
f.heidari@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of oxygen and placebo on clinical outcomes in patients with non ST elevation acute coronary syndrome
Public title
Comparison of the effect of oxygen and placebo in treatment of non ST elevation acute coronary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18-84 years; diagnosed with acute coronary syndrome with non ST segment elevation according to Branvald criteria; no clinical evidence of heart failure; no chronic lung disease or other respiratory problems; lack of cardiac arrest or cardiogenic shock before entering the hospital; oxygen saturation above 90% on admission; absence of congenital heart disease.
Exclusion criteria: Need for inotropic support; having ST elevation acute myocardial infarction; oxygen saturation less than 90% during hospitalization; emergency coronary angioplasty or emergency coronary artery bypass during hospitalization; death.
Age
From 18 years old to 84 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Bushehr University of Medical Sciences
Street address
Bushehr University of Medical Sciences, Salman Farsi street, Bushehr, Bushehr, Iran