Stroke
Conditions
Keywords
High flow oxygen therapy, Oxygen desaturation index, Acute ischemic stroke
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.
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
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen desaturation index | 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
| Measure | Time frame | Description |
|---|---|---|
| Lowest oxygen saturation | In the first 24 hours of study period | — |
| The number of subjects with oxygen desaturation | In the first 24 hours of study period | — |
| Mean oxygen saturation | In the first 24 hours of study period | — |
| NIHSS changes | at the 7th day of admission or at discharge date | The NIHSS at randomization minus the NIHSS at the 7th day of admission |
| The number of subjects with NIHSS improvement by 4 or more | at the 7th day of admission or at discharge date | — |
| Percentages of cumulative time of oxygen desaturation | In the first 24 hours of study period | — |
Outcome results
None listed