Clinical trial NCT03122210: Comparaison of 2 SpO2 Level Measured by Pulse Oxymetry in Complications of Acute Coronary Syndrome.
Official title: Comparaison of 2 SpO2 Level Measured by Pulse Oxymetry in Complications of Acute Coronary Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infarction, Myocardial
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2017-04-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: During acute coronary syndrome, the American College of Cardiology and the American Heart Association recommend oxygen delivery to patients with less than 90% oxygen saturation. Oxygen therapy in these patients for a duration of at least 6 hours, but also stipulates that it is reasonable to administer oxygen to all acute coronary syndrome patients during the first six hours following the presentation. Hyperoxia also has well-established risks.

Our research hypotheses are:

(I) that current practices tend to use high oxygen flows resulting in high SpO2 levels during acute coronary syndrome.

(II) there is a high rate of desaturation in patients with acute coronary syndrome and an automatic adaptation of oxygen flows may reduce this frequency.

(III) that excessive oxygenation targets have no advantage. Our hypothesis is that maintaining a SpO2 of 90 to 94% is at least equivalent when compared to higher saturation objectives (SpO2 of 94 to 100%) with regard to the occurrence of complications in the patient in acute coronary syndrome . We will use two SpO2 targets with the FreeO2 system, 92 and 97%.

Detailed description: Hypoxemia is a common problem encountered during acute coronary syndrome. During acute coronary syndrome, the American College of Cardiology and the American Heart Association recommend oxygen delivery to patients with less than 90% oxygen saturation. Oxygen therapy in these patients for a duration of at least 6 hours , but also stipulates that it is reasonable to administer oxygen to all acute coronary syndrome patients during the first six hours Following the presentation. However, the studies underlying these guidelines are few and far between, most of them having been done more than forty years ago.

Hyperoxia also has well-established risks.

Our research hypotheses are:

(I) that current practices tend to use high oxygen flows resulting in high SpO2 levels during acute coronary syndrome.

(II) there is a high rate of desaturation in patients with acute coronary syndrome and an automatic adaptation of oxygen flows may reduce this frequency. This will be our primary endpoint and will be tested with the use of the automated oxygen delivery system.

(III) that excessive oxygenation targets have no advantage. Our hypothesis is that maintaining a SpO2 of 90 to 94% is at least equivalent when compared to higher saturation objectives (SpO2 of 94 to 100%) with regard to the occurrence of complications in the patient in acute coronary syndrome . We will use two SpO2 targets with the FreeO2 system, 92 and 97%.

Eligibility criteria: Inclusion Criteria:

* Patients should have a proven diagnosis of acute high risk coronary syndrome as defined by the American Heart Association:
* myocardial infarction with or without ST segment elevation: Ischemic changes in the electrocardiogram and positive cardiac biomarkers.
* or Unstable angina: Typical or atypical cardiac symptoms, Ischemic electrocardiographic changes, Normal cardiac biomarkers.

Exclusion Criteria:

* inclusion in another study refusing co-enrollment
* chronic obstructive pulmonary disease with CO2 retention
* sleep apnea-hypopnea syndrome with CPAP
* traumatic brain injury
* pregnancy
* Age \<18 years
* Mechanical invasive or non-invasive ventilation
* patient needing more than 5 lpm of oxygen to have SpO2 \> 95%

Primary outcomes:
measure: The frequency of significant desaturations (SpO2 <90% for at least 30 seconds)
timeFrame: 24 hours
Secondary outcomes:
measure: Significant rhythm disorders, ischemic events
timeFrame: 24 hours
measure: The percentage of time spent in the target SpO2 area in the second and third groups, defined as SpO2 +/- 2% of the targeted SpO2 (range 90-94% for group 92% and range 95-99% for group 97%)
timeFrame: 24 hours
Other outcomes:
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