StrokeNCT03402594
High Flow Oxygen Therapy and Acute Ischemic Stroke
A study testing High flow oxygen and Low flow oxygen in people with Stroke, run by Chulalongkorn University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- High flow oxygen and Low flow oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Stroke
- Being tested
- High flow oxygen, Low flow oxygen
- Keywords
- High flow oxygen therapy, Oxygen desaturation index, Acute ischemic stroke
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Low flow oxygenDevice
Oxygen cannula with a flow rate of 2 liter/minute
| Study group | Role | What they receive |
|---|---|---|
| No oxygen | No intervention | No oxygen supplementation given |
| Low flow oxygen | Active comparator | Oxygen cannula with a flow rate of 2 liter/minute Receives: 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 Receives: Device: High flow oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: In the first 24 hours of study period
Secondary outcomes (6)
Mean oxygen saturation
Measured: In the first 24 hours of study period
Lowest oxygen saturation
Measured: In the first 24 hours of study period
The number of subjects with oxygen desaturation
Measured: In the first 24 hours of study period
Percentages of cumulative time of oxygen desaturation
Measured: In the first 24 hours of study period
NIHSS changes
The NIHSS at randomization minus the NIHSS at the 7th day of admission
Measured: at the 7th day of admission or at discharge date
The number of subjects with NIHSS improvement by 4 or more
Measured: at the 7th day of admission or at discharge date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start1 Jul 2016
- Primary completion31 Mar 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402594
- Sponsor's protocol ID
- 436/59
- Status last verified
- Nov 2017
- First submitted
- 11 Jan 2018
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Flow Oxygen Therapy on Oxygen Desaturation Index in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03402594
- Acronym / sponsor ID
- 436/59
- Conditions
- Stroke
- Keywords
- High flow oxygen therapy, Oxygen desaturation index, Acute ischemic stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 18 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No oxygen | No intervention | –No oxygen supplementation given |
| Low flow oxygen | Active comparator | Device: Low flow oxygenOxygen cannula with a flow rate of 2 liter/minute |
| High flow oxygen | Experimental | Device: High flow oxygenHeated 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High flow oxygenHeated 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 |
| Low flow oxygenOxygen cannula with a flow rate of 2 liter/minute | Device | Low flow oxygen |
Primary outcome
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
6 secondary outcomes
Mean oxygen saturation
Time frame: In the first 24 hours of study period
Lowest oxygen saturation
Time frame: 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
Percentages of cumulative time of oxygen desaturation
Time frame: In the first 24 hours of study period
NIHSS changes
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing High flow oxygen and Low flow oxygen in people with Stroke, run by Chulalongkorn University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen desaturation index (time frame: In the first 24 hours of study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.