Very early rehabilitation or intensive telemetry after stroke: a pilot randomised trial. A randomized, controlled trial of computerized physiologic trend monitoring in an intensive care unit. Role of monitoring in management of acute ischemic stroke patients. Physiologic and behavioral effects of gentle human touch on preterm infants. Randomised controlled trial of graded exercise in chronic fatigue syndrome. Intermittent versus continuous electronic monitoring in labour: a randomised study. Physiologic stress reduction by a local anesthetic during newborn circumcision. Randomized, double-blind, placebo-controlled crossover trials of venlafaxine for hot flashes after breast cancer. A lower ongoing pregnancy rate can be expected when GnRH agonist is used for triggering final oocyte maturation instead of HCG in patients undergoing IVF with GnRH antagonists. Continuous glucose monitoring-guided insulin adjustment in children and adolescents on near-physiological insulin regimens: a randomized controlled trial. Parental presence during induction of anesthesia: physiological effects on parents.
Stroke patients are more likely to make a good recovery if they receive care in a well-organised stroke unit. However, there are uncertainties about how best to provide such care. We studied 2 key aspects of early stroke unit care: early active mobilisation (EM) and automated monitoring (AM) for physiological complications such as hypoxia.
                This was an observer-blinded, factorial (2 x 2) pilot randomised controlled trial recruiting stroke patients within 36 h of symptom onset. The patients were randomised to 1 of 4 nurse-led treatment protocols: (a) standard stroke unit care, (b) EM, (c) AM or (d) combined EM and AM. The primary outcome was the Rankin score at 3 months. We also report the data on feasibility and safety.
                We randomised 32 patients (mean age = 65 years; mean baseline modified NIH score = 6). On unadjusted comparisons, the EM patients were significantly (p < 0.05) more likely to mobilise very early (within 1 h of randomisation) and to achieve walking by day 5 and were less likely to develop complications of immobility. The AM group was significantly (p < 0.05) more likely to have pre-defined physiological complication events detected. All these associations remained, but were less statistically significant, after correcting for age, baseline NIH score and co-interventions. There were no significant safety concerns.
                We have demonstrated the feasibility of implementing EM and AM for physiological complications in a randomised controlled trial. Larger trials are warranted to determine whether these interventions have clinical benefits.
                (c) 2010 S. Karger AG, Basel. To assess whether the provision of computerized physiologic trend data could improve outcome in newborn infants requiring intensive care.
                Randomized, controlled trial, with subsidiary questionnaire studies.
                Tertiary neonatal intensive care unit with 12 intensive care cots.
                All infants admitted between January 1991 and September 1993 who were < or =32 wks gestation or >32 wks gestation, and ventilated for >4 hrs or asphyxiated.
                Randomization to one of four groups for first 7 days of life: A) no display of trend data; B) continuous display of trend data; C1) alternating 24-hr display of trend data, starting with display in first 24 hrs; and C2) alternating 24-hr display of trend data, starting with no display in first 24 hrs.
                The short-term effects of monitoring on patient outcome was judged by volume of colloid given, number of blood gases taken, and by measurement taken from cranial Doppler ultrasound. Medium-term measures included time ventilated, time given supplemental oxygen, death, time to death or discharge, and cranial ultrasound at discharge. Long-term outcome was assessed by neurodevelopmental status at age 1 to 4 yrs of age. Staff and parent questionnaires assessed their respective attitudes to the introduction of this technology. None of the patient outcome measures, short-, medium-, or long-term, demonstrated any significant benefit from the provision of computerized physiologic trend monitoring. Staff questionnaires demonstrated an acceptance of the system and an improved understanding of neonatal physiology as a result of computerized physiologic trends. Parent questionnaires demonstrated increased anxiety caused by the system in 11% of parents, although only 1% of parents continued to have concerns if the system were able to help their child.
                A randomized, controlled trial was unable to demonstrate any benefit to patients resulting from the introduction of a computerized physiologic trend monitoring system. Benefits of the system have been recognized, however, in subsidiary studies, staff education, and research studies. Although several studies have demonstrated the effectiveness of specialist Stroke Unit (SU) care of stroke patients, there is still disagreement over how these units are best organized. We sought to clarify the role of continuous monitoring of physiological parameters in acute ischemic stroke.
                We conducted a prospective study of 268 first-ever ischemic stroke patients admitted to our Cerebrovascular Department and allocated, according to the availability of beds, to the SU or Cerebrovascular Unit (CU). Statistical analysis compared mortality and outcome at discharge, medical and neurological complications, and length of hospitalization in the 2 care settings.
                Two hundred sixty-eight patients were enrolled. A good outcome at discharge, observed in 114 SU patients (85%) and 78 CU patients (58%) (odds ratio, 2.63; 95% CI, 1.4 to 4.8; P<0.02), was found, on multivariate analysis, to be significantly related to type of care (SU versus CU). A significantly greater proportion of SU patients showed adverse changes in monitored parameters, which required acute medical treatment (SU: 64%; CU: 19%; P<0.0001). The mean duration of these complications was significantly shorter in the SU patients (SU: 1.0 day; CU: 2.4 days; P<0.02), and the outcome in patients experiencing complications covered by the monitoring protocol was significantly better in the SU (66%) than in the CU (35%) group (P<0.0001).
                Admission of acute stroke patients to a monitoring SU may positively influence their outcome at discharge. Confirmation of our findings in larger trials will indicate the need for a revision of the minimum requirements of SUs, with the addition of monitoring as a new requirement. The purpose of this study was to evaluate the effects of a gentle human touch (GHT) intervention provided to 42 preterm infants (27-33 weeks gestational age), for 10 min, three times daily for 10 days. There was no significant difference in mean HR levels or in percent of abnormal heart rate (HR) or O2 saturation comparing 10-min baseline (B), GHT, and 10-min post-touch (PT) phases. There were significantly lower levels of active sleep, motor activity, and behavioral distress during GHT compared to B and P phases. There were no differences among the 42 infants in the GHT group and 42 infants in a randomly assigned control group on any outcome variable including weight gain, morbidity status, or behavioral organization. The findings suggest that GHT generally is a safe and soothing type of touch to provide to young preterm infants, but that individual infant responses to touch need to be continuously monitored by NICU staff and parents. To investigate whether 12 weeks of graded exercise with pacing would improve specific physiological, psychological and cognitive functions in people with chronic fatigue syndrome (CFS).
                Randomised controlled trial.
                Human performance laboratory at the University of Western Australia.
                61 patients aged between 16 and 74 years diagnosed with CFS.
                Either graded exercise with pacing (32 patients) or relaxation/flexibility therapy (29 patients) performed twice a day over 12 weeks.
                Changes in any of the physiological, psychological or cognitive variables assessed.
                Following the graded exercise intervention, scores were improved for resting systolic blood pressure (P = 0.018), work capacity (W.kg(-1)) (P = 0.019), net blood lactate production (P = 0.036), depression (P = 0.027) and performance on a modified Stroop Colour Word test (P = 0.029). Rating of perceived exertion scores, associated with an exercise test, was lower after graded exercise (P = 0.013). No such changes were observed in the relaxation/flexibility condition, which served as an attention-placebo control.
                Graded exercise was associated with improvements in physical work capacity, as well as in specific psychological and cognitive variables. Improvements may be associated with the abandonment of avoidance behaviours. To compare the efficacy in detecting signs of fetal hypoxia in labour of intermittent (I-group) versus continuous (C-group) electronic fetal monitoring in women with low or moderate risk factors for fetal distress.
                A prospective, randomised study.
                A tertiary referral centre.
                Four thousand and forty-four parturients at low risk for obstetric complications with a reactive fetal heart rate admission test at arrival in labour. During the study period (October 5 1989 to May 31 1991), 5647 women were delivered in the labour ward. Of these, 1178 women (20.9%) were excluded because of high risk factors in pregnancy or at admission for labour, including women undergoing elective caesarean section. Of the remaining 4469 women 4044 (90.5%) were randomised to either intermittent (n = 2015) or continuous monitoring (n = 2029) during the first stage of labour.
                In the C-group the fetal heart rate was recorded continuously with electronic fetal monitoring during the first stage of labour. In the I-group the fetal heart rate was recorded with electronic fetal monitoring for 10 to 30 min every 2 to 2.5 h during the first stage of labour, and the fetal heart rate was auscultated every 15 to 30 min in between recording periods. If complications occurred, recording was changed to continuous. In the second stage of labour all the women were monitored continuously. Umbilical cord artery acid-base status was assessed at birth.
                Duration of electronic fetal monitoring, rates of abnormal fetal heart rate patterns, caesarean section for fetal distress, acidosis in umbilical cord arterial blood at birth, Apgar scores of less than 7 at 1 or 5 min, and referrals to the neonatal intensive care unit.
                There were no significant differences between the study groups in the incidence of ominous fetal heart rate recordings: 6.3% (I-group) versus 6.6% (C-group), or the interval from arrival to first detected abnormal fetal heart rate, although the number of suspicious fetal heart rate patterns was higher in the C-group (28.6%) than in the I-group (24.6%). In the I-group electronic fetal monitoring was performed for (median monitoring time) 38.8% of the first stage of labour as compared with 78.6% in the C-group. The incidence of caesarean section for fetal distress was similarly low in both groups: 1.2% versus 1.0%. There were no significant differences in the immediate neonatal outcome in terms of umbilical artery pH, Apgar scores, or admissions to the neonatal care unit.
                Intermittent use of electronic fetal monitoring at regular intervals (with stethoscopic auscultation in between) appears to be as safe as continuous electronic fetal monitoring in low risk labours. To evaluate the effectiveness of the dorsal penile nerve block in reducing the stress of circumcision upon newborns, physiologic measurements in 30 healthy full-term infants (including transcutaneous oxygen levels, crying time, heart rate, and respiratory rate) were monitored continuously before, during, and after the operation. Infants receiving the dorsal penile nerve block with lidocaine (1% Xylocaine) (N = 20) experienced significantly less stress, as evidenced by smaller decreases in transcutaneous oxygen pressure levels, less time spent crying, and smaller increases in heart rate, than infants circumcised in an identical manner without anesthetic (N = 10). No complications resulted from injection of the local anesthetic or from the circumcision procedure itself. Inasmuch as dorsal penile nerve block has a low complication rate, is simple to learn, and adds little time or expense to the overall procedure, and if it proves to be as effective clinically as the physiologic data indicate, the dorsal penile nerve block should be considered for every infant undergoing circumcision. Although venlafaxine reduces self-reported hot flashes, no data have established the drug's impact on physiologically documented hot flashes. Two randomized, double-blind, placebo-controlled crossover trials examined the efficacy of two doses of venlafaxine in relation to physiological and self-reported hot flashes and other outcomes, including negative affect, fatigue, sleep, and quality of life.
                Sample: 57 breast cancer survivors in the low-dose study; 20 in the high-dose study. Setting: university cancer clinics in the Southeast and Midwest. Intervention: 37.5 mg of venlafaxine (low-dose study) or 75 mg of venlafaxine (high-dose study). Measures: hot flash frequency (physiological monitor, diary, and event marker), hot flash severity (diary), hot flash bother (diary), and questionnaires for hot flash impact on daily life, negative affect, fatigue, sleep, and quality of life.
                Subjective but not physiological hot flash measures showed placebo effects. Venlafaxine resulted in modest decreases in hot flashes, but only hot flash interference improved differentially at the higher dose. The timing of venlafaxine's effects on hot flashes varied by dose. Only women with a > or =50% decrease in physiological hot flashes experienced significant improvement in fatigue, sleep quality, and quality of life. Although side effects were mild, most patients discontinued venlafaxine long-term.
                Although venlafaxine resulted in modest and acute reductions in hot flashes with few side effects, it may not be tolerable to some patients long-term. At least 50% relief in physiological hot flashes may be needed for patients to demonstrate improvement in other outcomes, including decreased fatigue, improved sleep, and improved quality of life. Eliciting an endogenous LH surge by GnRH-agonist for the induction of final oocyte maturation may be more physiological compared with the administration of HCG. However, the efficacy of this intervention in patients treated for IVF with GnRH antagonists remains to be assessed.
                106 patients were randomized to receive either 10 000 IU urinary HCG or 0.2 mg Triptorelin for triggering final oocyte maturation. Ovarian stimulation for IVF was performed with a fixed dose of 200 IU recombinant FSH and GnRH antagonist was started on stimulation day 6. Luteal phase was supported with micronized vaginal progesterone and oral estradiol. The study was monitored continuously for safety and stopping rules were established.
                No significant differences were present in the number of cumulus-oocyte complexes retrieved, in the proportion of metaphase II oocytes, in fertilization rates or in the number and quality of the embryos transferred between the two groups. However, a significantly lower probability of ongoing pregnancy in the GnRH agonist arm prompted discontinuation of the trial, according to the stopping rules established (odds ratio 0.11; 95% confidence interval 0.02-0.52).
                Lower probability of ongoing pregnancy can be expected when GnRH agonist is used for triggering final oocyte maturation instead of HCG in patients undergoing ovarian stimulation for IVF with GnRH antagonists. This randomized controlled trial assesses the effect on glycemic control of continuous glucose monitoring system (CGMS)-guided insulin therapy adjustment in young people with type 1 diabetes on intensive diabetes treatment regimens with continuous subcutaneous insulin infusion (CSII) or glargine.
                Pediatric subjects were recruited if they had an HbA(1c) (A1C) <10% and had been on CSII or glargine for at least 3 months. Thirty-six subjects were randomized to insulin adjustment on the basis of 72 h of CGMS every 3 weeks or intermittent self-monitoring of blood glucose (SMBG) for 3 months. A1C and fructosamine were measured at baseline and 6 and 12 weeks. Follow-up A1C was measured at 6 months. Mean baseline A1C was 8.2% (n = 19) in the CGMS group and 7.9% (n = 17) in the control group.
                There was a significant improvement in A1C from baseline values in both groups, but there was no difference in the degree of improvement in A1C at 12 weeks between the CGMS (-0.4% [95% CI -0.7 to -0.1]) and the control group (-0.4% [-0.8 to 0.2]). In the CGMS group, improved A1C was at the cost of increased duration of hypoglycemia.
                CGMS is no more useful than intermittent fingerstick SMBG and frequent review in improving diabetes control in reasonably well-controlled patients on near-physiological insulin regimens when used in an outpatient clinic setting. The authors conducted a randomized controlled trial to determine whether parental presence during induction of anesthesia (PPIA) is associated with parental physiologic and behavioral manifestations of stress.
                Children and their parents (N = 80) were randomly assigned to one of three groups: (1) PPIA; (2) PPIA plus 0.5 mg/kg oral midazolam; and (3) control (no PPIA or midazolam). The effect of the group assignment on parental heart rate (HR), parental blood pressure, and parental skin conductance level (SCL) were assessed. Both parental HR and parental SCL were monitored continually. Anxiety of the parent and child was also assessed.
                Parental HR increased from baseline until the induction of anesthesia (P = 0.001). A group-by-time effect ( P= 0.005) was also found. That is, throughout the induction period there were several time points at which parents in the two PPIA groups had a significantly higher HR than did parents in the control group (P < 0.05). Similarly, SCL was found to increase in all parents from baseline until induction of anesthesia (P = 0.001). Significant group differences in SCL changes over time were found as well (P = 0.009). State anxiety and blood pressure following induction of anesthesia did not differ significantly between groups ( P= nonsignificant). Examination of parental Holter data revealed no rhythm abnormalities and no electrocardiogram changes indicating ischemia.
                The authors found that PPIA is associated with increased parental HR and SCL. However, no increased incidence of electrocardiogram abnormalities were found in parents present during induction of anesthesia.
Continuous monitoring of physiological variables for the first two to three days may improve outcomes and prevent complications. Attention to the changes in physiological variables is a key feature of a stroke unit, and can most likely be aided by continuous monitoring without complications related to immobility or to treatments triggered by the relief of abnormal physiological variables. Well-designed, high-quality studies are needed because many questions remain open and deserve further research. These include when to start continuous monitoring, when to interrupt it, which people should be given priority, and which treatments are most appropriate after the identification of abnormalities in physiological variables.