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High Flow Oxygen Therapy and Acute Ischemic Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High flow oxygen
Low flow oxygen
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring High flow oxygen therapy, Oxygen desaturation index, Acute ischemic stroke

Eligibility Criteria

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

Inclusion Criteria:

  1. Age of 18 or more
  2. Clinical and radiographic findings including computerized tomography of brain compatible with acute ischemic stroke
  3. Presentation within 72 hours after the stroke onset
  4. National of Health Stroke Scale (NIHSS) of 5 or more,
  5. Limb weakness defined as motor power grade of 4 or less,
  6. Able to give informed consent, or the next of kin was willing to give assent

Exclusion Criteria:

  1. Recognized indications for oxygen treatment, such as oxygen saturation on room air of less than 92%, acute left ventricular failure, severe pneumonia, pulmonary emboli, and chronic respiratory failure treated with home oxygen supplementation
  2. Recognized contraindications for oxygen treatment including chronic hypercapnia and type II respiratory failure
  3. Subjects with previous diagnosis of obstructive sleep apnea (OSA) or highly suspicious of OSA, screened by STOPBANG score of 5 or more

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Active Comparator

    Experimental

    Arm Label

    No oxygen

    Low flow oxygen

    High flow oxygen

    Arm Description

    No oxygen supplementation given

    Oxygen cannula with a flow rate of 2 liter/minute

    Heated humidified high flow oxygen cannula (Optiflow; temperature of 34°C and fractional inspired oxygen of 0.24) with a flow rate of 20 liter/minute

    Outcomes

    Primary Outcome Measures

    Oxygen desaturation index
    The number of times per hour that the oxygen saturation measured by pulse oximetry drop from baseline more than 4% for at least 10 seconds

    Secondary Outcome Measures

    Mean oxygen saturation
    Lowest oxygen saturation
    The number of subjects with oxygen desaturation
    Percentages of cumulative time of oxygen desaturation
    NIHSS changes
    The NIHSS at randomization minus the NIHSS at the 7th day of admission
    The number of subjects with NIHSS improvement by 4 or more

    Full Information

    First Posted
    January 11, 2018
    Last Updated
    January 11, 2018
    Sponsor
    Chulalongkorn University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03402594
    Brief Title
    High Flow Oxygen Therapy and Acute Ischemic Stroke
    Official Title
    Effects of High Flow Oxygen Therapy on Oxygen Desaturation Index in Patients With Acute Ischemic Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2016 (Actual)
    Primary Completion Date
    March 31, 2017 (Actual)
    Study Completion Date
    June 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chulalongkorn University

    4. Oversight

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

    5. Study Description

    Brief Summary
    Hypoxemia is common in acute ischemic stroke and associated with neurological deterioration and mortality. However, the benefit of oxygen therapy is controversial. Severity of stroke may affect the benefit of oxygen supplementation. Abnormal breathing patterns are commonly found among stroke patients and may increase the risk of hypoxemia. High flow nasal cannula (HFNC) has several advantages from controllable fraction of inspired oxygen (FiO2), reduction of nasopharyngeal resistance and positive end expiratory pressure effect. In this study, we aimed to assess the therapeutic effect of HFNC on oxygen desaturation index (ODI) and neurological outcomes in stroke patients with moderate and severe severities, compared with no and low flow oxygen supplementation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    High flow oxygen therapy, Oxygen desaturation index, Acute ischemic stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    No oxygen
    Arm Type
    No Intervention
    Arm Description
    No oxygen supplementation given
    Arm Title
    Low flow oxygen
    Arm Type
    Active Comparator
    Arm Description
    Oxygen cannula with a flow rate of 2 liter/minute
    Arm Title
    High flow oxygen
    Arm Type
    Experimental
    Arm Description
    Heated humidified high flow oxygen cannula (Optiflow; temperature of 34°C and fractional inspired oxygen of 0.24) with a flow rate of 20 liter/minute
    Intervention Type
    Device
    Intervention Name(s)
    High flow oxygen
    Intervention Description
    Heated humidified high flow oxygen cannula (Optiflow; temperature of 34°C and fractional inspired oxygen of 0.24) with a flow rate of 20 liter/minute
    Intervention Type
    Device
    Intervention Name(s)
    Low flow oxygen
    Intervention Description
    Oxygen cannula with a flow rate of 2 liter/minute
    Primary Outcome Measure Information:
    Title
    Oxygen desaturation index
    Description
    The number of times per hour that the oxygen saturation measured by pulse oximetry drop from baseline more than 4% for at least 10 seconds
    Time Frame
    In the first 24 hours of study period
    Secondary Outcome Measure Information:
    Title
    Mean oxygen saturation
    Time Frame
    In the first 24 hours of study period
    Title
    Lowest oxygen saturation
    Time Frame
    In the first 24 hours of study period
    Title
    The number of subjects with oxygen desaturation
    Time Frame
    In the first 24 hours of study period
    Title
    Percentages of cumulative time of oxygen desaturation
    Time Frame
    In the first 24 hours of study period
    Title
    NIHSS changes
    Description
    The NIHSS at randomization minus the NIHSS at the 7th day of admission
    Time Frame
    at the 7th day of admission or at discharge date
    Title
    The number of subjects with NIHSS improvement by 4 or more
    Time Frame
    at the 7th day of admission or at discharge date

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age of 18 or more Clinical and radiographic findings including computerized tomography of brain compatible with acute ischemic stroke Presentation within 72 hours after the stroke onset National of Health Stroke Scale (NIHSS) of 5 or more, Limb weakness defined as motor power grade of 4 or less, Able to give informed consent, or the next of kin was willing to give assent Exclusion Criteria: Recognized indications for oxygen treatment, such as oxygen saturation on room air of less than 92%, acute left ventricular failure, severe pneumonia, pulmonary emboli, and chronic respiratory failure treated with home oxygen supplementation Recognized contraindications for oxygen treatment including chronic hypercapnia and type II respiratory failure Subjects with previous diagnosis of obstructive sleep apnea (OSA) or highly suspicious of OSA, screened by STOPBANG score of 5 or more

    12. IPD Sharing Statement

    Learn more about this trial

    High Flow Oxygen Therapy and Acute Ischemic Stroke

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