Comparaison of 2 SpO2 Level Measured by Pulse Oxymetry in Complications of Acute Coronary Syndrome.

Infarction, Myocardial Clinical Trial

— FreeO2 SCA  

Official title:

Comparaison of 2 SpO2 Level Measured by Pulse Oxymetry in Complications of Acute Coronary Syndrome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03122210
• Other study ID #: 20502
• Status: Completed
• Phase: N/A
• First received: April 18, 2017
• Last updated: December 18, 2017
• Start date: January 5, 2010
• Est. completion date: April 13, 2017

Study information

• Verified date: December 2017
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 13, 2017
• Est. primary completion date: August 8, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Infarction
• Infarction, Myocardial
• Myocardial Infarction

Intervention

Device:
• Automated oxygen administration
In the control group, usual oxygen administration and titration is planned

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The frequency of significant desaturations (SpO2 <90% for at least 30 seconds)		24 hours
Secondary	Significant rhythm disorders, ischemic events		24 hours
Secondary	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%)		24 hours