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The Stroke Oxygen Supplementation Study

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Title: The Stroke Oxygen Supplementation Study


1
The Stroke Oxygen Supplementation Study
www.so2s.co.uk
  • Chief Investigator Prof. Christine Roffe
  • Trial Manager Dr Sarah Pountain
  • North Staffordshire Combined Healthcare Trust

Funded by National Institute For Research
Research for Patient Benefit
2
Hypoxia
ABG kPa Saturation Normal 12.6
0.1 97 2 Mild hypoxia 9.3 lt95
Moderate hypoxia 8.0 lt92 Severe
hypoxia 6.7 lt85 Life threatening 5.3 lt75
3
Oxygen saturation in acute stroke patients
Roffe et al, Stroke 2003342641-2645.
4
Unexpected nocturnal hypoxia in acute 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
5
Post-stroke hypoxia is usually caused by
complications
100
90
SpO2 ()
80
68 year old male with left hemiparesis and
pneumonia.
  • Airway Obstruction
  • Aspiration
  • Pneumonia
  • Pulmonary emboli
  • Fluid overload
  • Sleep apnoea

6
Adverse effects of hypoxia after stroke 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
7
Adverse effects of hypoxia after stroke
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.

8
Adverse effects nocturnal hypoxia after stroke
Increased level of disability
10 desaturations/h
gt10 desaturations/h
Good, Stroke 199627252-259
Silva,Cerebrovasc Dis 200111(suppl 4)70,
Sandberg, JAGS 200149391-397.
9
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.
10
When to start oxygen? Views of British Stroke
Physicians
Arora et al, Br J Cardiol 200512456-458.
11
Oxygen saturation on arrival in hospital
Oxygen Saturation ()
Age (years)
n105 Mean age 74.0 years (SD 9.6 years) Mean
oxygen saturation 96.3 (SD 1.6)
Stroke Oxygen pilot Study in progress, baseline
demographic data,
12
Should we give oxygen to prevent hypoxia?
13
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.

14
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.
15
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.
16
Potential adverse effects of oxygen
Masking of an important warning sign of
underlying pathology Formation of toxic free
radicals Stress imposed by the mask or
cannula Drying of mucous membranes Hospital
acquired infection through the plastic
tubing Immobilization of the patient Unintended
effects on staff attitude to the
patient Respiratory depression in patients with
severe COPD
17
Oxygen for Stroke
  • Oxygen is increasingly given to acute stroke
    patients
  • No uniform guidelines for the prescription of
    oxygen to acute stroke patients
  • Variation amongst clinicians of when oxygen
    supplementation should be given

18
SOS Study
  • A multi-centre, randomised, open,
    blinded-endpoint study
  • Routine oxygen treatment for 72 h after a stroke

19
Aims of SOS Study
  • Main Hypothesis
  • Fixed dose oxygen treatment during the first 3
    days after an acute stroke improves outcome.
  • Secondary hypothesis
  • Restricting oxygen supplementation to night time
    only is more effective than continuous
    supplementation.

20
Protocol
  • The Stroke Oxygen Supplementation Study

21
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22
Eligibility for the study
  • Inclusion criteria
  • Adult patients with acute stroke
  • No definite indications or definite
    contraindications for O2 treatment
  • Within 24 hours of admission
  • Exclusion criteria
  • Potential indications for O2 treatment
  • O2 saturation on air lt90
  • dyspnoea
  • Medical indications for oxygen (PE, severe
    pneumonia, acute asthma)
  • Patients on long term oxygen for chronic lung
    disease
  • If the stroke is not the main clinical problem
  • Serious life threatening illness

23
Types of consent for SOS Study
  • Patient written consent
  • Relative/carer or legal representative consent
  • Independent Physician consent
  • Patient confirmation of consent (after recovery)

24
Baseline and Randomisation
  • Randomisation form
  • Baseline O2 saturation demographics
  • Date time of event
  • Glasgow Coma Scale
  • NIHSS
  • Predictors of outcome
  • Log on or phone to randomise
  • www.so2s.co.uk
  • Tel 0300 123 0891
  • Assigned to a treatment group

25
Treatment Groups
  • No routine O2
  • O2 per nasal cannulae for 3 nights
  • 3 L/min if O2 saturation at baseline is 93
  • 2 L/min if O2 saturation at baseline is gt 93
  • Continuous oxygen per nasal cannulae for 72 hours
  • 3 L/min if O2 saturation at baseline is 93
  • 2 L/min if O2 saturation at baseline is gt 93

26
1 week post recruitment
  • Local, trained, research team member
  • 7 days 1 day after enrolment
  • Confirm diagnosis
  • Document death
  • NIHSS
  • Compliance with the intervention
  • Complications
  • Data entered online

27
3, 6 12 month post recruitment
  • Centrally by SOS team
  • Questionnaire sent to patient
  • Deaths
  • Discharge status
  • Modified Rankin Score
  • Barthel ADL score
  • Nottingham EADL score
  • EuroQuol score
  • Memory
  • Sleep
  • Speech

28
Outcome Measures
  • No. of patients with neurological deterioration
  • Mortality
  • Highest/lowest oxygen saturation during the first
    72hr
  • Modified Rankin score
  • Quality of life
  • Level of disability

29
Study Documentation
30
SOS Study File
  • SOS Study Contact Details
  • Study Documentation
  • Investigator Site Personnel Signed Agreements
  • Regulatory/Ethics Committee
  • Subject Documentation
  • Safety Reporting
  • Data Collection
  • Study Monitoring Reports
  • Correspondence

31
1. SOS Study Contact Details
  • SOS Study Manager
  • Dr Sarah Pountain
  • E-mail sarah.pountain_at_northstaffs.nhs.uk
  • Tel 0300 123 0891
  • SOS Chief Investigator
  • Dr Christine Roffe
  • E-mail christine.roffe_at_northstaffs.nhs.uk
  • Tel 0300 123 1465
  • Stroke Research Office, North Staffordshire
    Combined Healthcare NHS Trust, Holly Lodge, 62
    Queens Road, Hartshill, Stoke-on-Trent, ST4 7LH.
  • Tel 0300 123 0891
  • 24 HOUR RANDOMISATION
  • http//www.so2s.co.uk
  • EMERGENCY CONTACT DETAILS
  • Mobile No 07740 372852 (main) 07734 068408
    (back-up)

32
2. Study Documents
  • http//www.so2s.co.uk
  • Version updates e-mail PI, announced on website
  • On site headed note paper - consent forms,
    patient information sheets and the GP letter
  • File Notes
  • Equipment Validation
  • Patient Document Tracking Log
  • SOPs

33
3. Investigator Site Personnel
  • Delegation Log
  • Training Log
  • CVs Job Description
  • Financial Information
  • CTA

34
4. Regulatory/Ethics Committee
  • MHRA Approval
  • Oxygen Data Sheet
  • Ethics Application Approval
  • R D Approval
  • Safety updates
  • Reports
  • End of trial notification
  • Correspondence to/from ethics/MHRA

35
5. Subject Documentation
  • Screening Log
  • Subject Enrolment/Identification Log
  • Signed consent forms

36
6. Safety Reporting
  • Adverse Events report on RD-RF-SOS-001 (from
    website) fax and e-mail to Sponsor within 14 days
  • SAEs SUSARs notify study centre immediately,
    complete SAE form and fax to Study centre AND
    sponsor within 24 hours of becoming aware of the
    event.
  • Reporting of Safety Measures - notify study
    centre immediately complete form RD-RF-SOS-002
    (from website) fax or e-mail to study centre AND
    sponsor, within 24 hours.

37
7. Data Collection
  • Completing the CRF
  • Consent types of, obtaining, consent procedure
    dialogue
  • Information sheets and consent forms
  • Randomising patients into SOS study
  • How to randomise using the web based system
  • Completing the week 1 follow up
  • Inputting the week 1 follow up
  • Long term follow up
  • Notification of death
  • Completed notification of death forms

38
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39
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40
  • Click on New Randomisation
  • Confirm your site
  • Select clinician
  • Identifying details - patient surname, forename,
    sex, DOB, Unit no.
  • Eligibility time since admission, time since
    stroke, expected to die within 1 year from
    non-stroke related illness, indications for O2,
    contraindications for O2
  • Patient details date of stroke, time of stroke,
    O2 given in the ambulance (if yes how much), O2
    given on arrival (if yes how much)

41
  • Medical History COAD, other chronic lung
    problem, heart failure, IHD, AF
  • GCS
  • NIHSS
  • Prognostic factors - live alone?, independent in
    daily living, lift affect arm, walk unaided, O2
    sat. at randomisation
  • Consent
  • Confirm all details
  • Check randomisation options

42
Go back
43
1 Week follow up data input
  • Log into database from
  • http//www.so2s.co.uk
  • Click on patient forms
  • Select relevant patient

44
Go back
45
Notification of death
  • In the event of death can you please complete the
    notification of death form for your records and
    complete the form on line.
  • To access the form online log onto the SOS
    website (http//www.so2s.co.uk).
  • Click on Click here to randomise or enter data.
  • Enter user name and password, select live as data
    type.
  • Select Patient forms to enter data.
  • Select the patient and click on View Details.
  • Select Notification of Death from the left hand
    side of the screen and click on View form.
  • Enter details, click on save.
  • Click on Exit.
  • Exit website, will automatically log out when
    website closed down.

46
8. Study Monitoring Reports
  • Final Study Reports
  • Interim Reports
  • Publications/Abstracts
  • Safety Updates and Reports
  • Initiation Visit Report
  • Visit Log
  • Close out Letter

47
9. Correspondence
  • General Correspondence
  • SOS Newsletter
  • Minutes of Meetings

48
Study Contacts
  • SOS Study Manager
  • Dr Sarah Pountain
  • E-mail sarah.pountain_at_northstaffs.nhs.uk
  • Tel 0300 123 0891
  • SOS Chief Investigator
  • Dr Christine Roffe
  • E-mail christine.roffe_at_northstaffs.nhs.uk
  • Tel 0300 123 1465
  • Stroke Research Office, North Staffordshire
    Combined Healthcare NHS Trust, Holly Lodge, 62
    Queens Road, Hartshill, Stoke-on-Trent ST4 7LH

49
  • Trial Steering Committee
  • Trial Management Committee
  • Prof. Richard Lindley
  • Prof. Martin Dennis
  • Prof. Lalit Kalra
  • Prof. Sian Prothero
  • Jane Daniels
  • Mrs Peta Bell
  • Dr Christine Roffe
  • Prof. Peter Jones
  • Prof. Peter Crome
  • Prof. Richard Gray
  • Mr Peter Mrs Linda Handy (Strokes R Us)

Patient Representatives
Data Monitoring Safety Committee
  • Peter Linda Handy
  • Mrs Peta Bell
  • Prof. S Jackson
  • Prof. T Robinson
  • Dr Martyn Lewis

International Advisory Committee
Sponsor
  • Prof. Richard Lindley
  • North Staffordshire Combined Healthcare NHS Trust
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