Background High blood pressure is common in acute stroke and is a predictor of poor outcome; however, large trials of lowering blood pressure have given variable results, and the management of high blood pressure in ultra-acute stroke remains unclear. We investigated whether transdermal glyceryl trinitrate (GTN; also known as nitroglycerin), a nitric oxide donor, might improve outcome when administered very early after stroke onset. Methods We did a multicentre, paramedic-delivered, ambulance-based, prospective, randomised, sham-controlled, blinded-endpoint, phase 3 trial in adults with presumed stroke within 4 h of onset, face-arm-speech-time score of 2 or 3, and systolic blood pressure 120 mm Hg or higher. Participants were randomly assigned (1:1) to receive transdermal GTN (5 mg once daily for 4 days; the GTN group) or a similar sham dressing (the sham group) in UKbased ambulances by paramedics, with treatment continued in hospital. Paramedics were unmasked to treatment, whereas participants were masked. The primary outcome was the 7-level modified Rankin Scale (mRS; a measure of functional outcome) at 90 days, assessed by central telephone follow-up with masking to treatment. Analysis was hierarchical, first in participants with a confirmed stroke or transient ischaemic attack (cohort 1), and then in all participants who were randomly assigned (intention to treat, cohort 2) according to the statistical analysis plan. This trial is registered with ISRCTN, number ISRCTN26986053.
The prevalence of hemiplegic shoulder pain (HSP) and associated factors was studied in patients with a stroke followed for 6 months after discharge from hospital. A questionnaire was used to evaluate shoulder symptoms and an examination of the shoulder and arm was carried out three times over 6 months. A total of 108 patients were studied with a mean age of 71 years. Sixty-nine patients (63.8%) developed HSP at some time during the study period. The number with HSP was 39 at discharge from hospital, 59 at 8 weeks post-discharge and 36 at 6 months. Nine carers reported lifting the patient by pulling on the hemiplegic arm, even though six of them had received advice about correct lifting techniques. Reduced shoulder shrug was associated with HSP at all times and reduced pinch grip was also associated with HSP at discharge from hospital. Patients who required help with transfers were more likely to suffer with HSP. There was no difference in the prevalence of HSP in patients treated at the day hospital compared to those who received domiciliary physiotherapy. It is concluded that HSP is common after a stroke and the prevalence increases in the first weeks after discharge from hospital. Stroke patients and their carers need advice about correct handling of the hemiplegic arm, and more work is required to ensure that correct handling occurs after discharge in patients at high risk of this unpleasant complication.
SummaryBackgroundResults of small trials indicate that fluoxetine might improve functional outcomes after stroke. The FOCUS trial aimed to provide a precise estimate of these effects.MethodsFOCUS was a pragmatic, multicentre, parallel group, double-blind, randomised, placebo-controlled trial done at 103 hospitals in the UK. Patients were eligible if they were aged 18 years or older, had a clinical stroke diagnosis, were enrolled and randomly assigned between 2 days and 15 days after onset, and had focal neurological deficits. Patients were randomly allocated fluoxetine 20 mg or matching placebo orally once daily for 6 months via a web-based system by use of a minimisation algorithm. The primary outcome was functional status, measured with the modified Rankin Scale (mRS), at 6 months. Patients, carers, health-care staff, and the trial team were masked to treatment allocation. Functional status was assessed at 6 months and 12 months after randomisation. Patients were analysed according to their treatment allocation. This trial is registered with the ISRCTN registry, number ISRCTN83290762.FindingsBetween Sept 10, 2012, and March 31, 2017, 3127 patients were recruited. 1564 patients were allocated fluoxetine and 1563 allocated placebo. mRS data at 6 months were available for 1553 (99·3%) patients in each treatment group. The distribution across mRS categories at 6 months was similar in the fluoxetine and placebo groups (common odds ratio adjusted for minimisation variables 0·951 [95% CI 0·839–1·079]; p=0·439). Patients allocated fluoxetine were less likely than those allocated placebo to develop new depression by 6 months (210 [13·43%] patients vs 269 [17·21%]; difference 3·78% [95% CI 1·26–6·30]; p=0·0033), but they had more bone fractures (45 [2·88%] vs 23 [1·47%]; difference 1·41% [95% CI 0·38–2·43]; p=0·0070). There were no significant differences in any other event at 6 or 12 months.InterpretationFluoxetine 20 mg given daily for 6 months after acute stroke does not seem to improve functional outcomes. Although the treatment reduced the occurrence of depression, it increased the frequency of bone fractures. These results do not support the routine use of fluoxetine either for the prevention of post-stroke depression or to promote recovery of function.FundingUK Stroke Association and NIHR Health Technology Assessment Programme.
Background: The aim of this study was to determine whether upper airway obstruction occurring within the first 24 hours of stroke onset has an effect on outcome following stroke at 6 months. Traditional definitions used for obstructive sleep apnoea (OSA) are arbitrary and may not apply in the acute stroke setting, so a further aim of the study was to redefine respiratory events and to assess their impact on outcome. Methods: 120 patients with acute stroke underwent a sleep study within 24 hours of onset to determine the severity of upper airway obstruction (respiratory disturbance index, RDI-total study). Stroke severity (Scandinavian Stroke Scale, SSS) and disability (Barthel score) were also recorded. Each patient was subsequently followed up at 6 months to determine morbidity and mortality. Results: Death was independently associated with SSS (OR (95% CI) 0.92 (0.88 to 0.95), p,0.00001) and RDI-total study (OR (95% CI) 1.07 (1.03 to 1.12), p,0.01). The Barthel index was independently predicted by SSS (p = 0.0001; r = 0.259; 95% CI 0.191 to 0.327) and minimum oxygen saturation during the night (p = 0.037; r = 0.16; 95% CI 0.006 to 0.184). The mean length of the respiratory event most significantly associated with death at 6 months was 15 seconds (sensitivity 0.625, specificity 0.525) using ROC curve analysis. Conclusion: The severity of upper airway obstruction appears to be associated with a worse functional outcome following stroke, increasing the likelihood of death and dependency. Longer respiratory events appear to have a greater effect. These data suggest that long term outcome might be improved by reducing upper airway obstruction in acute stroke.
Background and Purpose-The prevalence of sleep-disordered breathing after stroke has been reported to be between 32% and 71%. However, the first 24-hour period, when upper airway obstruction may have a critical effect on the cerebral circulation because of hemodynamic fluctuations and repetitive hypoxia, has not been studied. Furthermore, data on prediction of upper airway obstruction after stroke are limited. This study sought to assess the prevalence of upper airway obstruction in the first 24 hours of stroke and to ascertain whether its occurrence could be predicted. Methods-One hundred twenty patients with acute stroke underwent a respiratory variable-only sleep study, started within 24 hours of onset of neurological symptoms. Sleep history and stroke characteristics were recorded on admission. Results-We found that 79%, 61%, and 45% of the patients had a respiratory disturbance index greater than 5, 10, and 15 events per hour, respectively. Patients had a significantly higher respiratory disturbance index when nursed in the supine (29 events per
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