High Flow Oxygen Therapy and Acute Ischemic Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03402594
• Other study ID #: 436/59
• Status: Completed
• Phase: N/A
• First received: January 11, 2018
• Last updated: January 11, 2018
• Start date: July 1, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: November 2017
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 30, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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
• Low flow oxygen
Oxygen cannula with a flow rate of 2 liter/minute

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Outcome

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