Stroke Circulatory System Stroke
Conditions
Interventions
300 patients with a clinical diagnosis of acute stroke will be recruited within 24 hours of hospital admission.
This is a prospective randomised open study of the effects of early routine fixed dose
Sponsors
Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients (either sex) will be eligible for trial inclusion if they were admitted with symptoms of an acute stroke within the preceding 24 h and if, in the doctor's opinion, there is no clear indication for and no clear contraindication against oxygen treatment (added as of 01/05/2008). 1. Identification: All patients admitted to the University Hospital of North Staffordshire with an acute stroke will be eligible to be considered for trial inclusion. They will be identified as potential participants by a member of the research team or by staff in the Medical Admissions Unit, Accident and Emergency (A&E), or the Emergency Admission Unit. 2. Approach: Potential participants will be approached by a member of the research team or the doctor admitting the patient. Because hypoxia is more likely to be detrimental early after the stroke, when the ischaemic penumbra either recovers or expands it is crucial to include patients as soon as possible after the stroke onset into the trial. Patients will therefore be approached as soon as they enter hospital via the Medical Assessment Unit or the Accident and Emergency department, or at the next earliest opportunity on a medical ward up to 24 hours after admission. 3. Recruitment: The study will be explained to potential participants and they will be invited to take part. The patient will then be given an information leaflet. If he/she agrees to take part they will be recruited to the trial after informed consent has been given. If the patient does not disagree, but is incompetent to give fully informed consent, assent will be sought from the next of kin using the same procedure.
Exclusion criteria
Exclusion criteria: Added as of 01/05/2008: 1. Patients who have recognised indications for oxygen treatment such as: 1.1. Oxygen saturation on air less than 90% 1.2. Hypoxia associated with acute left ventricular failure, severe pneumonia and pulmonary embolus 1.3. Chronic respiratory failure treated with long term oxygen at home 2. Recognised contra-indications to fixed dose oxygen treatment (2 - 3 l/min/vy nasal tubes): type II respiratory failure (contra-indication to fixed dose oxygen as given in this trial) 3. The stroke is not the patient's main clinical problem: the patient has another serious life-threatening illness likely to lead to death within the next few months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Death and disability using the following measures: 1. Death and disability (Rankin Score greater than three) at six months 2. Scandinavian Stroke Scale at week one 3. Mortality up to six months 4. Rankin Score at six months 5. Nottingham EADL score at six months | — |
Secondary
| Measure | Time frame |
|---|---|
| Added as of 01/05/2008: 1. Potential side effects of oxygen treatment 2. Frequency of protocol violation 3. National Institutes of Health Stroke Scale (NIHSS)/Scandinavian Stroke Scale (SSS) at one week 4. Oxygen saturation while on treatment To assess the feasibility of recruiting stroke patients within 24 hours of hospital admission. | — |
Countries
United Kingdom
Outcome results
None listed