The Stroke Oxygen Study: a multi-centre, prospective, randomised, open, blinded-endpoint study of routine oxygen treatment in the first 72 hours after a stroke
| ISRCTN | ISRCTN52416964 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52416964 |
| EudraCT/CTIS number | 2006-003479-11 |
| Secondary identifying numbers | 06/Q2604/109 |
- Submission date
- 19/06/2007
- Registration date
- 10/07/2007
- Last edited
- 03/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Christine Roffe
Scientific
Scientific
SOS STudy, Stroke Research, Medical Illustrations
Royal Infirmary
Prince's Road
Hartshill
Stoke-on-Trent
ST4 7LN
United Kingdom
| Phone | +44 (0)1782 555875 |
|---|---|
| Christine.roffe@northstaffs.nhs.uk |
Study information
| Study design | Multi-centre prospective randomised open blinded-endpoint study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at http://www.so2s.co.uk/ |
| Scientific title | The Stroke Oxygen Study: a multi-centre, prospective, randomised, open, blinded-endpoint study of routine oxygen treatment in the first 72 hours after a stroke |
| Study acronym | SO2S |
| Study objectives | Main hypothesis: Fixed dose oxygen treatment during the first three days after an acute stroke improves outcome. Secondary hypothesis: Restricting oxygen supplementation to night time only is more effective than continuous supplementation. The pilot study of this trial can be found at ISRCTN12362720 (http://www.isrctn.com/ISRCTN12362720). |
| Ethics approval(s) | Local Research Ethics Committee (Mellor House, Corporation Street, Stafford, ST16 3SR, UK), 31/10/2006, ref: 06/Q260/109. Protocol version 2 approved on 24/01/2007 and on 26/06/2008. |
| Health condition(s) or problem(s) studied | Stroke, cerebral infarct, intracerebral haemorrhage, cerebrovascular disease |
| Intervention | Treatment group 1: no routine oxygen supplementation during the first 72 hours after randomisation. Treatment group 2: oxygen per nasal cannula overnight (21:00 - 7:00) at a flow rate of 3 L/min (if baseline oxygen saturation is 93% or below) or at a flow rate of 2 L/min (if baseline oxygen saturation is greater than 93%) during the first three nights after randomisation. Treatment group 3: oxygen per nasal cannula continuously (day and night) at a flow rate of 3 L/min (if baseline oxygen saturation is 93% or below) or a flow rate of 2 L/min (if baseline oxygen saturation is greater than 93%) during the first 72 hours after randomisation. All patients will have regular observations of vital signs (blood pressure, heart rate, temperature and oxygen saturation) as per the local protocol of the stroke unit, but at least six-hourly. Treatment of any abnormal findings will be independent of trial allocation. Patients who require oxygen or changes in the dose of oxygen for clinical reasons at any time of the trial will be given the concentration of oxygen they require. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Oxygen |
| Primary outcome measure | Modified Rankin Scale score at 3 months |
| Secondary outcome measures | 1. Secondary outcomes at 1 week: 1.1. Mortality 1.2. Number of patients with neurological deterioration (death or a greater than 4 point increase in the National Institutes of Health Stroke Scale [NIHSS]) 1.3. Deaths 1.4. Highest oxygen saturation during the first 72 hours 1.5. Lowest oxygen saturation during the first 72 hours 2. Secondary outcomes at 3 months: 2.1. Mortality 2.2. Percentage of patients living at home 2.3. Ability to perform activities of daily living (Barthel index) 2.4. Quality of life (EuroQuol) 2.5. Extended Activities of Daily Living (Nottingham EADL score) |
| Overall study start date | 20/04/2008 |
| Completion date | 01/11/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 6000 |
| Key inclusion criteria | Adult patients (either sex) are eligible for trial inclusion if they were admitted with symptoms of an acute stroke within the preceding 24 hours, and if, in the doctors opinion, there is no clear indication for and no clear contraindication against oxygen treatment: 1. Potential indications for oxygen treatment could be: 1.1. Oxygen saturation on air less than 90% 1.2. Hypoxia associated with acute left ventricular failure 1.3. Severe pneumonia 1.4. Pulmonary embolus 1.5. Chronic respiratory failure patients treated with long term oxygen at home 2. Potential contraindications to fixed dose oxygen treatment could be: 2.1. Type 2 respiratory failure 2.2. Very severe hypoxia 3. Medical centres are eligible for participation in the study if they admit patients with acute stroke, are able to provide oxygen treatment and monitor oxygen saturation, and if there is a local researcher who will act as the principal investigator for the locality |
| Key exclusion criteria | Patients will be excluded from the trial if: 1. The responsible doctor considers the patient to have definite indications for or contraindications to oxygen treatment at a rate of 2 - 3 L/min. The decision will be left to the responsible clinician 2. The stroke is not the main clinical problem 3. He/she has another serious life-threatening illness likely to lead to death within the next few months. This group of patients is excluded because it is unlikely that they are going to derive any benefit from the trial treatment |
| Date of first enrolment | 20/04/2008 |
| Date of final enrolment | 01/11/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Infirmary
Stoke-on-Trent
ST4 7LN
United Kingdom
ST4 7LN
United Kingdom
Sponsor information
North Staffordshire Combined Healthcare NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research & Development Department
North Staffordshire Combined Healthcare NHS Trust
Trust Headquarters
Bellringer Road
Trentham
Stoke-on-Trent
ST4 8HH
England
United Kingdom
| Phone | +44 (0)1782 441687 |
|---|---|
| r&d@northstaffs.nhs.uk | |
| Website | http://www.nsch-tr.wmids.nhs.uk/site/show_page.php3?page_id=1 |
"ROR" |
https://ror.org/02d5d0r05 |
Funders
Funder type
Government
North Staffordshire Combined Healthcare NHS Trust (UK)
No information available
Keele University
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Alternative name(s)
- La Universidad de Keele
- Location
- United Kingdom
Research for Patient Benefit Programme
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NIHR Research for Patient Benefit Programme, RfPB
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 31/03/2014 | Yes | No | |
| Statistical Analysis Plan | statistical analysis plan | 16/06/2014 | No | No | |
| Results article | results | 26/09/2017 | Yes | No | |
| Results article | results | 01/03/2018 | Yes | No |
Editorial Notes
03/04/2018: Publication reference added.
04/10/2017: Publication reference added.
01/05/2008: The overall trial start date was changed from 01/11/2007 to 20/04/2008.
