High Flow Oxygen Therapy and Acute Ischemic Stroke

January 11, 2018 updated by: Chulalongkorn University

Effects of High Flow Oxygen Therapy on Oxygen Desaturation Index in Patients With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No oxygen
No oxygen supplementation given
Active Comparator: Low flow oxygen
Oxygen cannula with a flow rate of 2 liter/minute
Device: Low flow oxygen
Oxygen cannula with a flow rate of 2 liter/minute
Experimental: 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
Device: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

March 31, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

January 11, 2018

First Submitted That Met QC Criteria

January 11, 2018

First Posted (Actual)

January 18, 2018

Study Record Updates

Last Update Posted (Actual)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 11, 2018

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 436/59

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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