CClinicalTrials.gg
CompletedNCT03402594Updated Jan 18, 2018

High Flow Oxygen Therapy and Acute Ischemic Stroke

An interventional study of High flow oxygen and Low flow oxygen in Stroke, sponsored by Chulalongkorn University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-18.

Sponsored by Chulalongkorn University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Stroke

Keywords

  • High flow oxygen therapy
  • Oxygen desaturation index
  • Acute ischemic stroke
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • No intervention
    No oxygen

    No oxygen supplementation given

  • Active comparator
    Low flow oxygen

    Oxygen cannula with a flow rate of 2 liter/minute

    Device: Low flow oxygen

  • Experimental
    High flow oxygen

    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

    Device: High flow oxygen

Interventions

  • DeviceHigh flow oxygen

    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

  • DeviceLow flow oxygen

    Oxygen cannula with a flow rate of 2 liter/minute

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: In the first 24 hours of study period

Secondary outcomes

  1. Mean oxygen saturation

    Time frame: In the first 24 hours of study period

  2. Lowest oxygen saturation

    Time frame: In the first 24 hours of study period

  3. The number of subjects with oxygen desaturation

    Time frame: In the first 24 hours of study period

  4. Percentages of cumulative time of oxygen desaturation

    Time frame: In the first 24 hours of study period

  5. NIHSS changes

    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

  6. The number of subjects with NIHSS improvement by 4 or more

    Time frame: at the 7th day of admission or at discharge date

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03402594
Lead sponsor
Chulalongkorn University
Responsible party
Sponsor
First posted
Jan 18, 2018
Start date
Jul 1, 2016
Primary completion
Mar 31, 2017
Completion
Jun 30, 2017
Last update
Jan 18, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion