High Flow Oxygen Therapy and Acute Ischemic Stroke

NCT ID: NCT03402594

Last Updated: 2018-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2017-06-30

Brief Summary

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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

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No oxygen

No oxygen supplementation given

Group Type NO_INTERVENTION

No interventions assigned to this group

Low flow oxygen

Oxygen cannula with a flow rate of 2 liter/minute

Group Type ACTIVE_COMPARATOR

Low flow oxygen

Intervention Type DEVICE

Oxygen cannula with a flow rate of 2 liter/minute

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

Group Type EXPERIMENTAL

High flow oxygen

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Low flow oxygen

Oxygen cannula with a flow rate of 2 liter/minute

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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436/59

Identifier Type: -

Identifier Source: org_study_id

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