NCT03402594

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jul 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
Last Updated

January 18, 2018

Status Verified

November 1, 2017

Enrollment Period

9 months

First QC Date

January 11, 2018

Last Update Submit

January 11, 2018

Conditions

Stroke

Keywords

High flow oxygen therapyOxygen desaturation indexAcute ischemic stroke

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

    at the 7th day of admission or at discharge date

  • +1 more secondary outcomes

Study Arms (3)

No oxygen

NO INTERVENTION

No oxygen supplementation given

Low flow oxygen

ACTIVE COMPARATOR

Oxygen cannula with a flow rate of 2 liter/minute

Device: Low flow oxygen

High flow oxygen

EXPERIMENTAL

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

Interventions

High flow oxygenDEVICE

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

High flow oxygen
Low flow oxygenDEVICE

Oxygen cannula with a flow rate of 2 liter/minute

Low flow oxygen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

StrokeIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 18, 2018

Study Start

July 1, 2016

Primary Completion

March 31, 2017

Study Completion

June 30, 2017

Last Updated

January 18, 2018

Record last verified: 2017-11