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Comparaison of 2 SpO2 Level Measured by Pulse Oxymetry in Complications of Acute Coronary Syndrome. (FreeO2 SCA)

Primary Purpose

Infarction, Myocardial

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Automated oxygen administration
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infarction, Myocardial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Other

    Other

    Other

    Arm Label

    Control group

    FreeO2 with SpO2 target = 92%

    FreeO2 with SpO2 target =97%

    Arm Description

    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.

    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%.

    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%.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Significant rhythm disorders, ischemic events
    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%)

    Full Information

    First Posted
    April 18, 2017
    Last Updated
    December 18, 2017
    Sponsor
    Laval University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03122210
    Brief Title
    Comparaison of 2 SpO2 Level Measured by Pulse Oxymetry in Complications of Acute Coronary Syndrome.
    Acronym
    FreeO2 SCA
    Official Title
    Comparaison of 2 SpO2 Level Measured by Pulse Oxymetry in Complications of Acute Coronary Syndrome.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 5, 2010 (Actual)
    Primary Completion Date
    August 8, 2013 (Actual)
    Study Completion Date
    April 13, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Laval University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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%.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infarction, Myocardial

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    Other
    Arm Description
    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.
    Arm Title
    FreeO2 with SpO2 target = 92%
    Arm Type
    Other
    Arm Description
    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%.
    Arm Title
    FreeO2 with SpO2 target =97%
    Arm Type
    Other
    Arm Description
    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%.
    Intervention Type
    Device
    Intervention Name(s)
    Automated oxygen administration
    Other Intervention Name(s)
    Usual oxygen administration
    Intervention Description
    In the control group, usual oxygen administration and titration is planned
    Primary Outcome Measure Information:
    Title
    The frequency of significant desaturations (SpO2 <90% for at least 30 seconds)
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    Significant rhythm disorders, ischemic events
    Time Frame
    24 hours
    Title
    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%)
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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%

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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