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Completed

NCT Number: NCT03402594

High Flow Oxygen Therapy and Acute Ischemic Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High flow oxygen

Device

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

Low flow oxygen

Device

Oxygen cannula with a flow rate of 2 liter/minute

Primary outcomes

  1. Oxygen desaturation index

    Time frame: In the first 24 hours of study period

    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 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

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

    The NIHSS at randomization minus the NIHSS at the 7th day of admission

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

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

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

Effects of High Flow Oxygen Therapy on Oxygen Desaturation Index in Patients With Acute Ischemic Stroke

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 18, 2018
Registry last updated
Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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