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From the Department of Neurology, Academic Hospital Groningen, Groningen, the Netherlands.
| Abstract |
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Methods— Both units were organized with the same standard care and multidisciplinary approach to nursing and rehabilitation. A blinded observer assessed functional outcome at 3 months with the modified Rankin scale (mRS) and Barthel Index (BI). End points were (1) poor outcome, defined as either mRS 4 or BI <60 or the need for institutional care and (2) mortality.
Results— Fifty-four patients meeting the inclusion criteria were randomized. The groups were well matched for baseline characteristics, stroke subtype, stroke severity, vascular risk factors, and prognostic factors. Poor outcome was seen in 7 (25.9%) patients in the SCMU group and in 13 (48.1%) in the SU group (P=0.16). Mortality was lower in the SCMU group than in the SU group (1 [3.7%] vs 7 [25.9%]; odds ratio, 0.11 [95% CI, 0.02 to 0.96], P=0.05).
Conclusions— This pilot study suggests that admission of acute stroke patients to an SCMU may reduce mortality and poor outcome. A larger trial is required to confirm these findings.
Key Words: ischemia • stroke assessment • stroke management • treatment outcome
| Introduction |
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| Subjects and Methods |
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Patients were stratified for stroke subtype (total anterior circulation syndrome, partial anterior circulation syndrome, or lacunar anterior syndrome), according to the criteria described by Bamford et al,15 and were randomly assigned to the SCMU or SU by an envelope system in a 1-to-1 manner. All patients received a CT scan of the head before randomization. ECG and routine blood tests were performed on admission, and other diagnostic procedures were performed when indicated. Neurological examination and the National Institute of Health stroke scale (NIHSS, a 46-point scale that assesses neurological deficit) scoring were performed by NIHSS-trained neurologists before randomization.
For ethical reasons, we decided to treat all patients in a similar way according to a standardized protocol. Thus, strategies to correct hypotension or excessive hypertension, hypoxia, elevated body temperature, and hyperglycemia, once detected, were identical for both groups . Glucose concentrations were determined every 6 hours. Patients in the SCMU were continuously monitored with Marquette Eagle 4000 monitors for at least 48-hours (and longer if required) for cardiac rhythm (5-lead ECG), body temperature (rectal thermometer), oxygen saturation (pulse oximeter), and blood pressure (noninvasive automatic measurement every 15 minutes), thereby allowing immediate interventions. After the first 48 hours, monitoring was stopped when the condition of patient was stable and the physiological variables showed no abnormality over the last 24 hours. After the monitoring period, patients were further treated in the conventional SU. In the conventional SU, observations consisted of manual measurement of body temperature, blood pressure, and heart rate 4 times a day. Oxygen saturation levels were determined when deemed necessary by the attending physician.
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The protocol for both units also included a swallowing test for the detection of dysphagia.16 A positive test led to immediate precautions to prevent aspiration (nil per os and nasogastric tube feeding). A bladder scan was used to assess urine retention. Saline solutions were administered intravenously 24 hours after admission to avoid or treat dehydration. Aspirin 100 mg was routinely given in the first 12 hours after admission. A low dose of nadroparin (2850 IU subcutaneously once a day) was used for deep venous thrombosis prophylaxis. In patients with suspected cardioembolic stroke or stroke progression, nadroparin 5700 IU subcutaneously was administered twice a day. Both units were organized with a team approach to nursing and rehabilitation. Key members of the team were trained stroke nurses and physiotherapists who developed a specific mobilization program, consisting of functional training and a modified motor relearning program. In the first 2 days after admission, patients were trained in bed; after 48 hours, patients were mobilized. Further plans were developed during weekly multidisciplinary stroke team meetings. An important goal was early discharge (within 14 days after admission) to a specialized stroke rehabilitation unit in either an affiliated nursing home or a rehabilitation clinic.
End Points
End points were assessed at 3 months and included (1) poor outcome, defined as either a modified Rankin scale (mRS) score 4 or a Barthel Index (BI) <60 or the need for institutional care due to the stroke17 and (2) mortality. The mRS is a 7-point scale that assesses overall function; death is rated as 6. The BI is a 100-point scale that assesses activities of daily living. A trained stroke nurse who was unaware of which treatment unit each patient had been allocate to determined both scales. Further end points were the number of abnormalities in physiological parameters that were detected during the acute phase of stroke and the number of interventions.
Statistical Analysis
Means, SD, and statistical tests for significance were calculated and performed using the statistical program SPSS for Windows. A t test was used to compare group means for continuous variables (eg, age, NIHSS). Fisher’s exact test and odd ratios (95% CIs) were used to test group differences for nominal variables (eg, stroke subtype, mortality, poor outcome). No corrections were made for multiple testing.
| Results |
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The groups were well matched for baseline characteristics, stroke subtype, stroke severity, vascular risk factors, and prognostic factors One patient in the SCMU group was admitted to the Intensive Care Unit within 48 hours after admission owing to ventricular fibrillation. Mean±SD time to discharge from the hospital was less in the SCMU group than in the conventional SU group (16±5 vs 25±7 days). None of the patients were lost to follow-up. The number of patients with poor outcome, defined as either mRS4 or BI<60, or institutionalization due to stroke was less in the SCMU group than in the SU group (7 [25.9%] vs 13 [48.1%]; odds ratio, 0.37 [95% CI, 0.12 to 1.18], P=0.15). Mortality was lower in the SCMU group than in the SU group (1 [3.7%] vs 7 [25.9%]; odds ratio, 0.11 [95% CI, 0.02 to 0.96], P=0.05). Causes and time of death are listed in .
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The number of complications and interventions during the first 48 hours after admission are shown . Hypoxia was detected in a higher proportion of patients in the SCMU. Accordingly, in the SCMU more patients promptly received oxygen therapy because of drops in oxygen saturation. Hypotension was observed more often in the SCMU, and plasma expanders were administered more frequently. The proportion of patients in whom elevated body temperature (>37.5°C) was identified was similar between the SCMU and conventional SU. In the conventional SU, antipyretics were given on the basis of 6-hourly temperature recordings, whereas in the SCMU antipyretics were given immediately after continuous rectal temperature monitoring detected a rise above 37.5°C. Continuous monitoring detected more patients with prior unknown (paroxysmal) cardiac arrhythmias, and 1 patient who developed ventricular fibrillation was successfully resuscitated.
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| Discussion |
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The results of a case-control study conducted by the group of Langhorne et al8 lend support to this concept that neurological impairment may be exacerbated by disturbances in these physiological variables. Patients who maintained physiological homeostasis showed improved outcomes. Acute medical interventions, targeted at maintaining these essential physiological variables (body temperature, oxygen saturation, and blood pressure) within a narrow physiological range, can be performed without delay when patients are intensively monitored.
To our knowledge, this is the first prospective, randomized study that examined whether intensive monitoring of acute stroke patients for body temperature, oxygen saturation, blood pressure, and cardiac rhythm further reduces poor outcome and mortality in addition to organized stroke-unit care. We found that admission to an SCMU was associated with a lower proportion of patients who died or had a poor outcome at 3 months. The latter was not significant, which is not unexpected in view of the relatively low number of patients that were included in the study. However, compared with other interventions in acute ischemic stroke, the effect of monitoring and normalization of physiological parameters on outcome was quite impressive. The beneficial effect can be attributed to the intensive physiological monitoring protocol because this was a single-center study wherein patients in both arms were very well matched and received the same standard care.
Patients with acute stroke are at risk of developing (ventricular) arrhythmias.10 In our study, 1 patient in the SCMU could be successfully resuscitated because ventricular fibrillation was promptly identified. Cardiac rhythm monitoring also identified newly diagnosed atrial fibrillation in 5 stroke-care unit patients versus 1 patient in the traditional stroke unit. These findings support the proposal of Oppenheimer and Hachinski10 that continuous cardiac rhythm monitoring should be an integral part of acute stroke management.
In summary, the results of this pilot study suggest that intensive monitoring of physiological variables during at least the first 48 hours after admission for acute ischemic stroke may reduce poor outcome and death. A larger trial is required to confirm these findings.
| Acknowledgments |
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Received May 16, 2002; revision received July 29, 2002; accepted August 14, 2002.
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