High Flow Oxygen Therapy and Acute Ischemic Stroke

Study Overview
=================
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.

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

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Device: High flow oxygen
* Device: Low flow oxygen


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No oxygen<br>No oxygen supplementation given | |
| Active Comparator: Low flow oxygen<br>Oxygen cannula with a flow rate of 2 liter/minute | Device: Low flow oxygen<br>* Oxygen cannula with a flow rate of 2 liter/minute<br>|
| Experimental: High flow oxygen<br>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<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | In the first 24 hours of study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean oxygen saturation |  | In the first 24 hours of study period | 
| 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 | 
| Percentages of cumulative time of oxygen desaturation |  | In the first 24 hours of study period | 
| NIHSS changes | The NIHSS at randomization minus the NIHSS at the 7th day of admission | at the 7th day of admission or at discharge date | 
| The number of subjects with NIHSS improvement by 4 or more |  | at the 7th day of admission or at discharge date | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High flow oxygen therapy, Oxygen desaturation index, Acute ischemic stroke