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The Stroke Oxygen Supplementation PILOT Study

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The Stroke Oxygen Supplementation PILOT Study. C. Roffe, K.Ali, A. Warusevitane, ... mRS modified Rankin Scale; Conclusion 1. This pilot study demonstrates ... – PowerPoint PPT presentation

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Title: The Stroke Oxygen Supplementation PILOT Study


1
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
2
Background
  • Incidence of hypoxia
  • 63 in the first 2 days
  • Sulter et al, J Neurol Sci 200017965-9.

3
Oxygen saturation within the first 72 hours of
acute stroke
Roffe et al, Stroke 2003342641-2645.
4
Adverse effects of hypoxia after stroke I Early
deterioration
381 consecutive patients with acute
stroke Oxygen saturation lt90 doubles risk of
early deterioration.
Silva et al, Cerebrovasc Dis 200111(suppl 4)70
5
Adverse effects of hypoxia after stroke II
Increased mortality
  • N153 assessed from arrival and during transfers
    till ward admission
  • Hypoxia defined as SpO2lt90 for gt10 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 200621166-172.

6
Unexpected nocturnal hypoxia in stroke patients
Time spent with an oxygen saturation lt90 at
night 52 more than 5 minutes 23 more than 30
minutes 15 more than 1 hour
Roffe et al, Stroke 2003342641-2645
7
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 1301631-1642
  • 95 O2 reduced neurological deficit and infarct
    size in rats
  • Liu et al J Cereb Blood Flow Metab.
    2006261274-84.

8
Routine oxygen supplementation
No oxygen
Oxygen
No oxygen
Oxygen
Oxygen
No oxygen
All strokes
Mild strokes SSSgt40 (top) Severe strokes SSS 40
(bottom)
Ronning and Guldvog, Stroke 1999302033-37.
9
Selective high dose (45L/min) short burst oxygen
supplementation
  • Methods
  • acute stroke lt12 h and perfusion-diffusion
    "mismatch" on MRI
  • RCT of high-flow oxygen via mask for 8 hours
    (n9) vs room air (n7)
  • 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. 200536797-802.
10
National and international Stroke Guidelines
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 saturationlt92 in 2007 American
Stroke Association Guidelines Oxygen if
saturation lt95 in 2003 and 2005 Oxygen if
saturation lt/92 in 2007
National Clinical Guidelines for Stroke. RCP
2004, 2008, NICE 2008, EUSI 2004, ESO 2007
ASA, Stroke. 200334(4)1056-83,
200536916-23, 2007381655-1711.
11
Stroke Oxygen PILOT Study
Routine oxygen supplementation during the first
three days after an acute stroke Prospective
randomized open study
12
(No Transcript)
13
SOS PILOT Study patient recruitment
14
Recruitment

15
Baseline Results
16
Baseline Results Cont…
17
Effect of oxygen supplementation on oxygen
saturation
SpO2 oxygen saturation a Time corrected to a
standard 8 hour night plt0.05, plt0.01,
plt0.01
18
Neurological Outcome at 1 week
NIHSS National Institute for Health Stroke
Scale plt0.001
19
Other results at 1 week
20
Completeness of follow up at 6 months
21
How was the questionnaire completed?
22
Outcomes at 6 months
mRS modified Rankin Scale
23
Conclusion 1
  • 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)

24
Conclusion 2
  • 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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