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The S troke O xygen S upplementation Study. 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. Hypoxia .

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the s troke o xygen s upplementation study

The Stroke Oxygen Supplementation Study

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



ABG [kPa] Saturation [%]

Normal 12.6 ±0.1 97 ±2

Mild hypoxia 9.3<95

Moderate hypoxia8.0<92%

Severe hypoxia 6.7<85

Life threatening 5.3<75

oxygen saturation in acute stroke patients
Oxygen saturation in acute stroke patients

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


Unexpected nocturnal hypoxia in

acute 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

post stroke hypoxia is usually caused by complications
Post-stroke hypoxia is usually caused by complications



SpO2 (%)


  • Airway Obstruction
  • Aspiration
  • Pneumonia
  • Pulmonary emboli
  • Fluid overload
  • Sleep apnoea

68 year old male with left hemiparesis and pneumonia.

adverse effects of hypoxia after stroke early deterioration
Adverse effects of hypoxia after stroke Early 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 increased mortality
Adverse effects of hypoxia after stroke Increased 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.


Adverse effects nocturnal hypoxia after stroke

Increased level of disability

£10 desaturations/h

>10 desaturations/h

Good, Stroke 1996;27:252-259

Silva,Cerebrovasc Dis 2001;11(suppl 4):70, Sandberg, JAGS 2001;49:391-397.

national and international stroke guidelines
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 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.

when to start oxygen views of british stroke physicians
When to start oxygen?Views of British Stroke Physicians

Arora et al, Br J Cardiol 2005;12:456-458.


Oxygen saturation on arrival in hospital

Oxygen Saturation (%)

Age (years)


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,


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.

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.


Routine oxygen supplementation

No oxygen


No oxygen



No oxygen

All strokes

Mild strokes SSS>40 (top)

Severe strokes SSS £ 40 (bottom)

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

potential adverse effects of oxygen
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

oxygen for stroke
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
s o s study
SOS Study

A multi-centre, randomised, open, blinded-endpoint study

Routine oxygen treatment for 72 h after a stroke

aims of s o s study
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.

eligibility for the study
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 <90%
      • 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
types of consent for s o s study
Types of consent forSOS Study
  • Patient written consent
  • Relative/carer or legal representative consent
  • Independent Physician consent
  • Patient confirmation of consent (after recovery)
baseline and randomisation
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
    • Tel: 0300 123 0891
  • Assigned to a treatment group
treatment groups
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 > 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 > 93%
1 week post recruitment
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
3 6 12 month post recruitment
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
outcome measures
Outcome Measures

No. of patients with neurological deterioration


Highest/lowest oxygen saturation during the first 72hr

Modified Rankin score

Quality of life

Level of disability

sos study file
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
1 sos study contact details
1. SOS Study Contact Details
  • SOSStudy Manager

Dr Sarah Pountain


Tel: 0300 123 0891

  • SOSChief Investigator

Dr Christine Roffe


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



Mobile No 07740 372852 (main) 07734 068408 (back-up)

2 study documents
2. Study Documents
  • 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
3 investigator site personnel
3. Investigator Site Personnel
  • Delegation Log
  • Training Log
  • CVs & Job Description
  • Financial Information
  • CTA
4 regulatory ethics committee
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
5 subject documentation
5. Subject Documentation
  • Screening Log
  • Subject Enrolment/Identification Log
  • Signed consent forms
6 safety reporting
6. Safety Reporting
  • Adverse Events – report on R&D-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 R&D-RF-SOS-002 (from website) fax or e-mail to study centre AND sponsor, within 24 hours.
7 data collection
7. Data Collection
  • Completing the CRF
  • Consent – types of, obtaining, consent procedure dialogue
  • Information sheets and consent forms
  • Randomising patient’s 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
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)
Medical History – COAD, other chronic lung problem, heart failure, IHD, AF
  • GCS
  • Prognostic factors - live alone?, independent in daily living, lift affect arm, walk unaided, O2 sat. at randomisation
  • Consent
  • Confirm all details
  • Check randomisation options
1 week follow up data input
1 Week follow up data input
  • Log into database from

  • Click on patient forms
  • Select relevant patient
notification of death
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 (
  • 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.
8 study monitoring reports
8. Study Monitoring & Reports
  • Final Study Reports
  • Interim Reports
  • Publications/Abstracts
  • Safety Updates and Reports
  • Initiation Visit Report
  • Visit Log
  • Close out Letter
9 correspondence
9. Correspondence
  • General Correspondence
  • SOS Newsletter
  • Minutes of Meetings
study contacts
Study Contacts
  • SOSStudy Manager

Dr Sarah Pountain


Tel: 0300 123 0891

  • SOSChief Investigator

Dr Christine Roffe


Tel: 0300 123 1465

Stroke Research Office, North Staffordshire Combined Healthcare NHS Trust, Holly Lodge, 62 Queens Road, Hartshill, Stoke-on-Trent ST4 7LH

Trial Management Committee

Trial Steering 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


  • Prof. Richard Lindley
  • North Staffordshire Combined Healthcare NHS Trust