SO2S
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
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Purpose:
To determine if a fixed dose oxygen treatment during the first three days after an acute stroke improves outcome and
if restricting oxygen supplementation to night time only is more effective than continuous supplementation.
Location(s):
United Kingdom
Year Started:
2008
Design:
A multi-centre, prospective, randomised, open, blinded-endpoint study.
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 doctor’s opinion, there is no clear indication for and no clear contraindication against oxygen treatment; potential indications for oxygen treatment could be: oxygen saturation on air less than 90%, hypoxia associated with acute left ventricular failure, severe pneumonia, pulmonary embolus, or chronic respiratory failure patients treated with long term oxygen at home; potential contraindications to fixed dose oxygen treatment could be: type 2 respiratory failure or very severe hypoxia.
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
Exclusion Criteria
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); stroke is not the main clinical problem; has another serious life-threatening illness likely to lead to death within the next few months.
Patient Involvement:
Patients will be randomized to one of three treatment groups: 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;
and 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. Patients will be assessed for outcome after one week using NIHSS, death and oxygen saturations. Patients will be assessed at 3 monts using Modified Rankin Scale, Barthel Index, EuroQuol, Nottingham EADL score, mortality, and percentage of patients living at home.
Primary Outcome:
Modified Rankin Scale score at three months.
Secondary Outcome:
Secondary outcomes at one week: mortality, number of patients with neurological deterioration (death or a greater than 4 point increase in the National Institutes of Health Stroke Scale [NIHSS]), deaths, highest oxygen saturation during the first 72 hours and lowest oxygen saturation during the first 72 hours .
Secondary outcomes at three months: mortality, percentage of patients living at home, ability to perform activities of daily living (Barthel index), quality of life (EuroQuol),
and Extended Activities of Daily Living (Nottingham EADL score).
Source of Information:
Controlled Trials.com
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Web Links and Publications:
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This information last updated on: 5/4/2010
Reviewed on: 09/09/2009.
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