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Head Position in Stroke Trial (HeadPoST)--sitting-up vs lying-flat positioning of patients with acute stroke: study protocol for a cluster randomised controlled trial.

ABSTRACT: Positioning a patient lying-flat in the acute phase of ischaemic stroke may improve recovery and reduce disability, but such a possibility has not been formally tested in a randomised trial. We therefore initiated the Head Position in Stroke Trial (HeadPoST) to determine the effects of lying-flat (0°) compared with sitting-up (? 30°) head positioning in the first 24 hours of hospital admission for patients with acute stroke.We plan to conduct an international, cluster randomised, crossover, open, blinded outcome-assessed clinical trial involving 140 study hospitals (clusters) with established acute stroke care programs. Each hospital will be randomly assigned to sequential policies of lying-flat (0°) or sitting-up (? 30°) head position as a 'business as usual' stroke care policy during the first 24 hours of admittance. Each hospital is required to recruit 60 consecutive patients with acute ischaemic stroke (AIS), and all patients with acute intracerebral haemorrhage (ICH) (an estimated average of 10), in the first randomised head position policy before crossing over to the second head position policy with a similar recruitment target. After collection of in-hospital clinical and management data and 7-day outcomes, central trained blinded assessors will conduct a telephone disability assessment with the modified Rankin Scale at 90 days. The primary outcome for analysis is a shift (defined as improvement) in death or disability on this scale. For a cluster size of 60 patients with AIS per intervention and with various assumptions including an intracluster correlation coefficient of 0.03, a sample size of 16,800 patients at 140 centres will provide 90 % power (? 0.05) to detect at least a 16 % relative improvement (shift) in an ordinal logistic regression analysis of the primary outcome. The treatment effect will also be assessed in all patients with ICH who are recruited during each treatment study period.HeadPoST is a large international clinical trial in which we will rigorously evaluate the effects of different head positioning in patients with acute stroke.ClinicalTrials.gov identifier: NCT02162017 (date of registration: 27 April 2014); ANZCTR identifier: ACTRN12614000483651 (date of registration: 9 May 2014). Protocol version and date: version 2.2, 19 June 2014.

SUBMITTER: Munoz-Venturelli P

PROVIDER: S-EPMC4460701 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature

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Head Position in Stroke Trial (HeadPoST)--sitting-up vs lying-flat positioning of patients with acute stroke: study protocol for a cluster randomised controlled trial.

Muñoz-Venturelli Paula P Arima Hisatomi H Lavados Pablo P Brunser Alejandro A Peng Bin B Cui Liying L Song Lily L Billot Laurent L Boaden Elizabeth E Hackett Maree L ML Heritier Stephane S Jan Stephen S Middleton Sandy S Olavarría Verónica V VV Lim Joyce Y JY Lindley Richard I RI Heeley Emma E Robinson Thompson T Pontes-Neto Octavio O Natsagdorj Lkhamtsoo L Lin Ruey-Tay RT Watkins Caroline C Anderson Craig S CS

Trials 20150605

<h4>Background</h4>Positioning a patient lying-flat in the acute phase of ischaemic stroke may improve recovery and reduce disability, but such a possibility has not been formally tested in a randomised trial. We therefore initiated the Head Position in Stroke Trial (HeadPoST) to determine the effects of lying-flat (0°) compared with sitting-up (≥ 30°) head positioning in the first 24 hours of hospital admission for patients with acute stroke.<h4>Methods/design</h4>We plan to conduct an internat ...[more]

PMID: 26040944

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Project description:Extended immobility has been associated with medical complications during hospitalization. However no clear recommendations are available for mobilization of ischemic stroke patients.As early mobilization has been shown to be feasible and safe, we tested the hypothesis that early sitting could be beneficial to stroke patient outcome.This prospective multicenter study tested two sitting procedures at the acute phase of ischemic stroke, in a randomized controlled fashion (clinicaltrials.org registration number NCT01573299). Patients were eligible if they were above 18 years of age and showed no sign of massive infarction or any contra-indication for sitting. In the early-sitting group, patients were seated out of bed at the earliest possible time but no later than one calendar day after stroke onset, whereas the progressively-sitting group was first seated out of bed on the third calendar day after stroke onset. Primary outcome measure was the proportion of patients with a modified Rankin score [0-2] at 3 months post stroke. Secondary outcome measures were a.) prevalence of medical complications, b.) length of hospital stay, and c.) tolerance to the procedure.One hundred sixty seven patients were included in the study, of which 29 were excluded after randomization. Data from 138 patients, 63 in the early-sitting group and 75 in the progressively-sitting group were analyzed. There was no difference regarding outcome of people with stroke, with a proportion of Rankin [0-2] score at 3 months of 76.2% and 77.3% of patients in the early- and progressive-sitting groups, respectively (p = 0.52). There was also no difference between groups for secondary outcome measures, and the procedure was well tolerated in both arms.Due to a slow enrollment, fewer patients than anticipated were available for analysis. As a result, we can only detect beneficial/detrimental effects of +/- 15% of the early sitting procedure on stroke outcome with a realized 37% power. However, enrollment was sufficient to rule out effect sizes greater than 25% with 80% power, indicating that early sitting is unlikely to have an extreme effect in either direction on stroke outcome. Additionally, we were not able to provide a blinded assessment of the primary outcome. Taking these limitations into account, our results may help guide the development of more effective acute stroke rehabilitation strategies, and the design of future acute stroke trials involving out of bed activities and other mobilization regimens.ClinicalTrials.gov NCT01573299.

Project description:BACKGROUND:The patient's position during spinal anesthesia administration plays a major role in the success of spinal needle insertion into the subarachnoid space. The traditional sitting position (TSP) is the standard position for spinal anesthesia administration, but the success rate for spinal anesthesia administration in the TSP is still quite low. The crossed-leg sitting position (CLSP) is one of the alternative positions for the administration of spinal anesthesia, which can increase the degree of lumbar flexion. OBJECTIVES:This study aimed to compare successful spinal needle placement to patients in the CLSP and patients in the TSP prior to undergoing urology surgery. METHODS:This study was a non-blinded, randomized controlled trial in patients undergoing spinal anesthesia for urologic procedures from March-October, 2015 in the central national hospital Dr. Cipto Mangunkusumo, Indonesia. After obtaining approval from the FMUI - RSCM (Faculty of Medicine Universitas Indonesia - Rumah Sakit Dr. Cipto Mangunkusumo) Ethical Committee and informed consent from patients, 211 subjects were allocated into two groups: the CLSP group (n = 105) and the TSP group (n = 106). The proportion of successful spinal needle placement to the subarachnoid space, ease of landmark palpation, and the number of needle-bone contacts in both groups were then assessed and analyzed. RESULTS:The rate of first-time successful spinal needle insertion was not significantly different between the CLSP and TSP groups (62.9% versus 55.7%, P > 0.05). Ease of landmark palpation in the CLSP group was not significantly different from that in the TSP group (86.7% versus 76.4%, P > 0.05). The number of needle-bone contacts in both groups were not significantly different (P > 0.05). The complication rates were similar in both groups. CONCLUSIONS:The rate of successful spinal needle placement in the CLSP group was not significantly different from that in the TSP group in patients undergoing urology surgery. The CLSP can be used as an alternative sitting position for administration of spinal anesthesia.

Project description:BACKGROUND:There is now a body of evidence on the effectiveness of interventions to reduce workplace sitting time. However, there has been limited reporting of how such interventions may impact behaviour both during and outside of work. Sitting, standing and stepping changes following a workplace intervention were examined across five timeframes (work time on work days; non-work time on work days; work days; non-work days; overall (i.e. work and non-work time on all days)), and the relationships between changes during and outside of work was assessed. METHODS:The cluster-randomised controlled trial, 'Stand Up Victoria', delivered a multi-component workplace-delivered intervention that successfully reduced workplace and overall sitting time (relative to controls). Separately, over the five timeframes, changes in device (activPAL3)-assessed outcomes - sitting; prolonged sitting (?30?min bouts); standing; and, stepping - were compared between intervention (n?=?114) and controls (n?=?84), along with the time-course of sitting changes during work hours, using mixed models. The potential relationships of changes during work with changes outside of work were examined using compositional data analysis. RESULTS:On workdays, intervention participants significantly (p?<?0.05) improved their activity profile relative to controls, with reduced sitting (-?117?min/8-h workday, 95% CI: -?141, -?93) and prolonged sitting (-?77?min/8?h workday, 95% CI: -?101, -?52); increased standing (114?min/8?h workday, 95% CI: 92, 136) and maintenance of stepping (3?min/8?h workday, 95% CI: -?7, 11, p?=?0.576). Effects were nearly identical for time at work; similar but slightly weaker for overall; and, small and non-significant outside of work on workdays and non-work days. Improvements occurred at all times, but not equally, during work hours (p?<?0.001). Correlations between changes during and outside of work on workdays were very weak in both the intervention group (r?=?-?0.07) and controls (r?=?-?0.09). CONCLUSIONS:Sitting time was reduced almost exclusively during work hours (via replacement with standing), with reductions evident during all working hours, to varying degrees. There was no evidence of compensation, with minimal change in activity outside of work, in response to changes in activity at work. Future interventions may benefit from exploring how best to elicit change throughout the whole day, and across work and non-work domains. TRIAL REGISTRATION:This trial was prospectively registered with the Australian New Zealand Clinical Trials register (ACTRN12611000742976) on 15 July 2011.

Project description:ImportanceBlack individuals and Hispanic individuals are less likely to recognize stroke and call 911 (stroke preparedness), contributing to racial/ethnic disparities in intravenous tissue plasminogen activator use.ObjectiveTo evaluate the effect of culturally tailored 12-minute stroke films on stroke preparedness vs the usual care practice of distributing stroke education pamphlets.Design, setting, and participantsCluster randomized clinical trial between July 26, 2013, and August 16, 2018, with randomization of 13 black and Hispanic churches located in urban neighborhoods to intervention or usual care. In total, 883 congregants were approached, 503 expressed interest, 375 completed eligibility screening, and 312 were randomized. Sixty-three individuals were ineligible (younger than 34 years and/or did not have at least 1 traditional stroke risk factor).InterventionsTwo 12-minute stroke films on stroke preparedness for black and Hispanic audiences.Main outcomes and measuresThe primary outcome was the Stroke Action Test (STAT), assessed at baseline, 6 months, and 12 months.ResultsIn total, 261 of 312 individuals completed the study (83.7% retention rate). Most participants were female (79.1%). The mean (SD) age of participants was 58.57 (11.66) years; 51.1% (n = 159) were non-Hispanic black, 48.9% (n = 152) were Hispanic, and 31.7% (n = 99) had low levels of education. There were no significant end-point differences for the STAT at follow-up periods. The mean (SD) baseline STAT scores were 59.05% (29.12%) correct for intervention and 58.35% (28.83%) correct for usual care. At 12 months, the mean (SD) STAT scores were 64.38% (26.39%) correct for intervention and 61.58% (28.01%) correct for usual care. Adjusted by education, a post hoc subgroup analysis revealed a mean (SE) intervention effect of 1.03% (0.44%) (P = .02) increase per month in the low-education subgroup (about a 10% increase in 12 months). In the high-education subgroup, the mean (SE) intervention effect was -0.05% (0.30%) (P = .86). Regarding percentage correct, the low-education intervention subgroup improved from 52.4% (7 of 21) to 66.7% (14 of 21) compared with the other subgroups.Conclusions and relevanceNo difference was observed in stroke preparedness at 12 months in response to culturally tailored 12-minute stroke films or conventional stroke education pamphlets. Additional studies are required to confirm findings from a post hoc subgroup analysis that suggested a significant education effect.Trial registrationClinicalTrials.gov identifier: NCT01909271.

Project description:BackgroundThe occipito-posterior (OP) fetal head position during the first stage of labour occurs in 10-34% of cephalic presentations. Most will spontaneous rotate in anterior position before delivery, but 5-8% of all births will persist in OP position for the third stage of labour. Previous observations have shown that this can lead to an increase of complications, such as an abnormally long labour, maternal and fetal exhaustion, instrumental delivery, severe perineal tears, and emergency caesarean section. Usual care in the case of diagnosis of OP position is an expectant management. However, maternal postural techniques have been reported to promote the anterior position of the fetal head for delivery. A Cochrane review reported that these maternal positions are well accepted by women and reduce back pain. However, the low sample size of included studies did not allow concluding on their efficacy on delivery outcomes, particularly those related to persistent OP position. Our objective is to evaluate the efficacy of maternal position in the management of OP position during the first stage of labour.Methods/designA randomised clinical trial is ongoing in the maternity unit of the Geneva University Hospitals, Geneva, Switzerland. The unit is the largest in Switzerland with 4,000 births/year. The trial will involve 438 women with a fetus in OP position, confirmed by sonography, during the first stage of the labour. The main outcome measure is the position of the fetal head, diagnosed by ultrasound one hour after randomisation.DiscussionIt is important to evaluate the efficacy of maternal position to correct fetal OP position during the first stage of the labour. Although these positions seem to be well accepted by women and appear easy to implement in the delivery room, the sample size of the last randomised clinical trial published in 2005 to evaluate this intervention had insufficient power to demonstrate clear evidence of effectiveness. If the technique demonstrates efficacy, it would reduce the physical and psychological consequences of complications at birth related to persistent OP position.Trial registrationClinicalTrials.gov, http://www.clinicaltrials.gov: (no. NCT01291355).

Dataset Information

Head Position in Stroke Trial (HeadPoST)--sitting-up vs lying-flat positioning of patients with acute stroke: study protocol for a cluster randomised controlled trial.

Publications

Head Position in Stroke Trial (HeadPoST)--sitting-up vs lying-flat positioning of patients with acute stroke: study protocol for a cluster randomised controlled trial.

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