High Flow Oxygen Therapy and Acute Ischemic Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Low flow oxygen; Device: High flow oxygen

• Registration Number: NCT03402594
• Lead Sponsor: Chulalongkorn University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-01
• Primary Completion: 2017-03-31
• Study Completion: 2017-06-30
• Status Verified: 2017-11
• Study First Submitted: 2018-01-11
• Study First Submitted QC: 2018-01-11
• Last Update Submitted: 2018-01-11
• Study First Posted: 2018-01-18
• Last Update Posted: 2018-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low flow oxygen	Low flow oxygen	Oxygen cannula with a flow rate of 2 liter/minute
High flow oxygen	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Percentages of cumulative time of oxygen desaturation	In the first 24 hours of study period
The number of subjects with NIHSS improvement by 4 or more	at the 7th day of admission or at discharge date
Lowest 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