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

NCT03122210 | Completed

• 1 other identifier: 20502
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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%.

Conditions

Infarction, Myocardial

Outcome Measures

Primary Outcomes (1)

• The frequency of significant desaturations (SpO2 <90% for at least 30 seconds)

  24 hours

Secondary Outcomes (2)

• Significant rhythm disorders, ischemic events

  24 hours

• 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

Study Arms (3)

Control group

OTHER

In this group, the nursing staff administed oxygen supply if necessary with the usual pratice in care unit for 24 hours after myocard infarction. In this group the SpO2 was recorded any time with FreeO2 device - recording mode.

Device: Automated oxygen administration

FreeO2 with SpO2 target = 92%

OTHER

In this group oxygen flow was automatically adjusted with the FreeO2 device (automatic titration of oxygen flow) to achived SpO2 target set by clinicial for 24 hours after myocard infarction. In this group, the SpO2 target was set at 92%.

Device: Automated oxygen administration

FreeO2 with SpO2 target =97%

OTHER

In this group oxygen flow was automatically adjusted with the FreeO2 device (automatic titration of oxygen flow) to achived SpO2 target set by clinicial for 24 hours after myocard infarction. In this group, the SpO2 target was set at 97%.

Device: Automated oxygen administration

Interventions

Automated oxygen administration DEVICE

In the control group, usual oxygen administration and titration is planned

Also known as: Usual oxygen administration

Control group; FreeO2 with SpO2 target = 92%; FreeO2 with SpO2 target =97%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%

Sponsors & Collaborators

• Laval University: lead

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: April 20, 2017
• Study Start: January 5, 2010
• Primary Completion: August 8, 2013
• Study Completion: April 13, 2017
• Last Updated: December 20, 2017

Record last verified: 2017-12