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The S troke O xygen S upplementation PILOT Study. C. Roffe, K. Ali, A. Warusevitane, S. Sills, S. Pountain, P Jones, R Gray, P. Crome North Staffordshire Combined Healthcare Trust University Hospital of North Staffordshire Brighton and Sussex University Hospital

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The s troke o xygen s upplementation pilot study

The Stroke Oxygen Supplementation PILOT Study

C. Roffe, K.Ali, A. Warusevitane, S. Sills, S. Pountain, P Jones, R Gray, P. Crome

North Staffordshire Combined Healthcare Trust

University Hospital of North Staffordshire

Brighton and Sussex University Hospital

University Hospital Birmingham

Keele University

The North Staffordshire

Medical Institute


Background
Background

Incidence of hypoxia

63% in the first 2 days

Sulter et al, J Neurol Sci 2000;179:65-9.


Oxygen saturation within the first 72 hours of acute stroke
Oxygen saturation within the first 72 hours of acute stroke

Roffe et al, Stroke 2003;34:2641-2645.


Adverse effects of hypoxia after stroke i early deterioration
Adverse effects of hypoxia after stroke IEarly deterioration

381 consecutive patients with acute stroke

Oxygen saturation <90 doubles risk of early deterioration.

Silva et al, Cerebrovasc Dis 2001;11(suppl 4):70


Adverse effects of hypoxia after stroke ii increased mortality
Adverse effects of hypoxia after stroke IIIncreased mortality

  • N=153 assessed from arrival and during transfers till ward admission

  • Hypoxia defined as SpO2<90 for >10% of assessment phase

  • Oxygen saturation lowest during transfers

  • Hypoxic pts are more likely to have a history of chest problems

  • Hypoxia doubles mortality, but no longer significant if corrected for stroke severity

  • No effect on long-term disability

    Rowat et al. Cerebrovasc Dis 2006;21:166-172.


Unexpected nocturnal hypoxia in stroke patients

Time spent with an oxygen saturation <90% at night

52% more than 5 minutes

23% more than 30 minutes

15% more than 1 hour

Roffe et al, Stroke 2003;34:2641-2645


Experimental Evidence

  • 100% oxygen increases oxygen delivery to the ischaemic brain in mice

  • Infarct size at 2 days reduced by 45%

    Shin, H. K. et al. Brain 2007 130:1631-1642

  • 95% O2 reduced neurological deficit and infarct size in rats

    Liu et al J Cereb Blood Flow Metab. 2006;26:1274-84.


Routine oxygen supplementation

No oxygen

Oxygen

No oxygen

Oxygen

Oxygen

No oxygen

All strokes

Mild strokes SSS>40 (top)

Severe strokes SSS £ 40 (bottom)

Ronning and Guldvog, Stroke 1999;30:2033-37.


Selective high dose 45l min short burst oxygen supplementation
Selective high dose (45L/min) short burst oxygen supplementation

Methods—

  • acute stroke <12 h and perfusion-diffusion "mismatch" on MRI

  • RCT of high-flow oxygen via mask for 8 hours (n=9) vs room air (n=7)

    Results—

  • Oxygen tended to improve stroke scale scores at 4 h and 1 week, and significantly at 24 h, but there was no significant difference at 3 months.

  • MRI lesion volumes were significantly reduced at 4 hours, but not subsequent time points.

  • Cerebral blood volume and blood flow within ischemic regions improved

  • More petechial hemorrhages (50% w oxygen vs 17% w room air)

Singhal et al . Stroke. 2005;36:797-802.


National and international stroke guidelines
National and international Stroke Guidelines supplementation

UK National Clinical Guidelines for Stroke

Arterial oxygen concentration should be maintained within normal limits 2004

Give Oxygen to maintain oxygen saturation at or above 95% 2008

European Stroke Initiative Recommendations for Stroke Management

2-4L/min when indicated in 2003

Oxygen if saturation<92% in 2007

American Stroke Association Guidelines

Oxygen if saturation <95% in 2003 and 2005

Oxygen if saturation </=92% in 2007

National Clinical Guidelines for Stroke. RCP 2004, 2008, NICE 2008, EUSI 2004, ESO 2007; ASA, Stroke. 2003;34(4):1056-83, 2005;36:916-23, 2007;38:1655-1711.


S troke o xygen pilot s tudy
S supplementation trokeOxygen PILOT Study

Routine oxygen supplementation during the first three days after an acute stroke

Prospective randomized open study



Recruitment
Recruitment supplementation


Baseline results
Baseline Results supplementation


Baseline results cont
Baseline Results Cont… supplementation


Effect of oxygen supplementation on oxygen saturation
Effect of oxygen supplementation on oxygen saturation supplementation

SpO2: oxygen saturation a Time corrected to a standard 8 hour night *p<0.05, **p<0.01, ***p<0.01


Neurological outcome at 1 week
Neurological Outcome supplementation at 1 week

NIHSS: National Institute for Health Stroke Scale; ***p<0.001


Other results at 1 week
Other results supplementation at 1 week


Completeness of follow up at 6 months
Completeness of follow –up supplementation at 6 months



Outcomes at 6 months
Outcomes supplementation at 6 months

mRS modified Rankin Scale;


Conclusion 1
Conclusion 1 supplementation

This pilot study demonstrates

  • That routine oxygen supplementation effectively increased oxygen saturation when given in a non- intensive clinical environment

  • That oxygen supplementation was well tolerated without observable adverse effects

  • That the outcomes are feasible and deliver over 95% returns at 1 week (clinical) and 6 months (questionnaire)


Conclusion 2
Conclusion 2 supplementation

This pilot study was not powered to look at neurological or functional outcomes or to do subgroup analyses

Results so far are that routine oxygen supplementation

  • Led to a small but statistically significant improvement in neurological outcome at 1 week

  • Had no significant effect on mortality and functional outcome at 6 months

    A larger study is required to determine whether routine oxygen supplementation is effective in reducing neurological deficit and improving functional outcome


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