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

Trials

Volumn 16, Issue 1, 2015, Pages

  Muñoz Venturelli, Paula ^a,b   Arima, Hisatomi ^a   Lavados, Pablo ^b,c   Brunser, Alejandro ^b   Peng, Bin ^d   Cui, Liying ^d   Song, Lily ^e   Billot, Laurent ^a   Boaden, Elizabeth ^f   Hackett, Maree L ^a,f   Heritier, Stephane ^a   Jan, Stephen ^a   Middleton, Sandy ^g   Olavarría, Verónica V ^b   Lim, Joyce Y ^a   Lindley, Richard I ^a   Heeley, Emma ^a   Robinson, Thompson ^h   Pontes Neto, Octavio ⁱ   Natsagdorj, Lkhamtsoo ^j   Lin, Ruey Tay ^k   Watkins, Caroline ^f,g   Anderson, Craig S ^a   more..

^a UNIVERSITY OF SYDNEY   (Australia)

^b UNIVERSIDAD DEL DESARROLLO   (Chile)

^c UNIVERSITY OF CHILE   (Chile)

^d PEKING UNION MEDICAL COLLEGE HOSPITAL   (China)

^e No 85 Hospital of PLA   (China)

^f UNIVERSITY OF CENTRAL LANCASHIRE   (United Kingdom)

^g AUSTRALIAN CATHOLIC UNIVERSITY   (Australia)

^h UNIVERSITY OF LEICESTER   (United Kingdom)

ⁱ UNIVERSITY OF SÃO PAULO   (Brazil)

^j Stroke Unit State Third Hospital   (Mongolia)

^k KAOHSIUNG MEDICAL UNIVERSITY HOSPITAL   (Taiwan)

more..

Author keywords

Cluster clinical trial; Head position; Ischemic stroke; Management; Nursing care; Outcomes; Stroke

Indexed keywords

ADOLESCENT; ADULT; ARTICLE; BRAIN HEMORRHAGE; BRAIN ISCHEMIA; CEREBROVASCULAR ACCIDENT; CLUSTER ANALYSIS; CONTROLLED STUDY; CROSSOVER PROCEDURE; FOLLOW UP; HEALTH CARE POLICY; HOSPITAL ADMISSION; HUMAN; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MULTICENTER STUDY; OPEN STUDY; OUTCOME ASSESSMENT; PATIENT CARE; PATIENT POSITIONING; PRACTICE GUIDELINE; PROGRAM EVALUATION; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SITTING; SUPINE POSITION; ADVERSE EFFECTS; ASIA; AUSTRALIA; BRAIN CIRCULATION; BRAZIL; CEREBRAL HEMORRHAGE; CHILE; CLINICAL PROTOCOL; CLINICAL TRIAL; COMPARATIVE STUDY; DISABILITY; HEAD; MORTALITY; PATHOPHYSIOLOGY; PREDICTIVE VALUE; PROCEDURES; RISK FACTOR; SAMPLE SIZE; STATISTICAL MODEL; STROKE; TIME FACTOR; TREATMENT OUTCOME; UNITED KINGDOM; VASCULARIZATION;

ASIA; AUSTRALIA; BRAZIL; CEREBRAL HEMORRHAGE; CEREBROVASCULAR CIRCULATION; CHILE; CLINICAL PROTOCOLS; CROSS-OVER STUDIES; DISABILITY EVALUATION; HEAD; HUMANS; LOGISTIC MODELS; PATIENT POSITIONING; PREDICTIVE VALUE OF TESTS; PROSPECTIVE STUDIES; RISK FACTORS; SAMPLE SIZE; STROKE; SUPINE POSITION; TIME FACTORS; TREATMENT OUTCOME; UNITED KINGDOM;

EID: 84934917911     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-015-0767-1     Document Type: Article

References (56)

1. Feigin VL, Lawes CM, Bennett DA, Barker-Collo SL, Parag V. Worldwide stroke incidence and early case fatality reported in 56 population-based studies: a systematic review. Lancet Neurol. 2009;8(4):355-69.
2. Feigin V, Lawes C, Bennett D, Anderson C. Stroke epidemiology: a review of population-based studies of incidence, prevalence, and case-fatality in the late 20th century. Lancet Neurol. 2003;2:43-53.
3. Astrup J, Siesjö BK, Symon L. Thresholds in cerebral ischemia - the ischemic penumbra. Stroke. 1981;12(6):723-5.
4. Eames PJ, Blake MJ, Dawson SL, Panerai RB, Potter JF. Dynamic cerebral autoregulation and beat to beat blood pressure control are impaired in acute ischaemic stroke. J Neurol Neurosurg Psychiatry. 2002;72(4):467-72.
5. Miyamoto Y, Tamura T, Hiura T, Nakamura T, Higuchi J, Mikami T. The dynamic response of the cardiopulmonary parameters to passive head-up tilt. Jpn J Physiol. 1982;32(2):245-58.
6. Butler GC, Xing HC, Hughson RL. Cardiovascular response to 4 hours of 6 degrees head-down tilt or of 30 degrees head-up tilt bed rest. Aviat Space Environ Med. 1990;61(3):240-6.
7. Olavarría VV, Arima H, Anderson CS, Brunser AM, Muñoz-Venturelli P, Heritier S, et al. Head position and cerebral blood flow velocity in acute ischemic stroke: a systematic review and meta-analysis. Cerebrovasc Dis. 2014;37(6):401-8.
8. Demchuk AM, Burgin WS, Christou I, Felberg RA, Barber PA, Hill MD, et al. Thrombolysis in brain ischemia (TIBI) transcranial Doppler flow grades predict clinical severity, early recovery, and mortality in patients treated with intravenous tissue plasminogen activator. Stroke. 2001;32(1):89-93.
9. Treger I, Streifler JY, Ring H. The relationship between mean flow velocity and functional and neurologic parameters of ischemic stroke patients undergoing rehabilitation. Arch Phys Med Rehabil. 2005;86(3):427-30.
10. Fan JY. Effect of backrest position on intracranial pressure and cerebral perfusion pressure in individuals with brain injury: a systematic review. J Neurosci Nurs. 2004;36(5):278-88.
11. Zhang Y, Rabinstein AA. Lower head of the bed position does not change blood flow velocity in subarachnoid hemorrhage. Neurocrit Care. 2011;14(1):73-6.
12. Schwarz S, Georgiadis D, Aschoff A, Schwab S. Effects of body position on intracranial pressure and cerebral perfusion in patients with large hemispheric stroke. Stroke. 2002;33(2):497-501.
13. Martino R, Foley N, Bhogal S, Diamant N, Speechley M, Teasell R. Dysphagia after stroke: incidence, diagnosis, and pulmonary complications. Stroke. 2005;36(12):2756-63.
14. Sellars C, Bowie L, Bagg J, Sweeney MP, Miller H, Tilston J, et al. Risk factors for chest infection in acute stroke: a prospective cohort study. Stroke. 2007;38(8):2284-91.
15. Grap MJ, Munro CL, Hummel 3rd RS, Elswick Jr RK, McKinney JL, Sessler CN. Effect of backrest elevation on the development of ventilator-associated pneumonia. Am J Crit Care. 2005;14(4):325-33.
16. Metheny NA, Davis-Jackson J, Stewart BJ. Effectiveness of an aspiration risk-reduction protocol. Nurs Res. 2010;59(1):18-25.
17. American Association of Neuroscience Nurses. Guide to the care of the hospitalized patient with ischemic stroke. 2nd ed. Glenview, IL: American Association of Neuroscience Nurses; 2008.
18. Brooks A, Lyerly MJ, Sands MA, James D, More R, Shahripour RB, et al. Risk of pneumonia associated with zero-degree head positioning (heads down) in acute ischemic stroke patients treated with intravenous tPA. Cerebrovasc Dis. 2013;35 Suppl 3:667.
19. Brethour MK, Nyström KV, Broughton S, Kiernan TE, Perez A, Handler D, et al. Controversies in acute stroke treatment. AACN Adv Crit Care. 2012;23(2):158-74.
20. Kagaya H, Inamoto Y, Okada S, Saitoh E. Body positions and functional training to reduce aspiration in patients with dysphagia. JMAJ. 2011;54(1):35-8.
21. Bernhardt J, Dewey H, Thrift A, Collier J, Donnan G. A very early rehabilitation trial for stroke (AVERT): phase II safety and feasibility. Stroke. 2008;39(2):390-6.
22. Cumming TB, Thrift AG, Collier JM, Churilov L, Dewey HM, Donnan GA, et al. Very early mobilization after stroke fast-tracks return to walking: further results from the phase II AVERT randomized controlled trial. Stroke. 2011;42(1):153-8.
23. AVERT Trial Collaboration group. Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial. Lancet. In press. doi: 10.1016/S0140-6736(15)60690-0 .
24. Rowat AM, Wardlaw JM, Dennis MS, Warlow CP. Patient positioning influences oxygen saturation in the acute phase of stroke. Cerebrovasc Dis. 2001;12(1):66-72.
25. Bhalla A, Tallis RC, Pomeroy VM. The effects of positioning after stroke on physiological homeostasis: a review. Age Ageing. 2005;34(4):401-6.
26. Bruno A, Shah N, Lin C, Close B, Hess DC, Davis K, et al. Improving modified Rankin Scale assessment with a simplified questionnaire. Stroke. 2010;41(5):1048-50.
27. Brott T, Adams Jr HP, Olinger CP, Marler JR, Barsan WG, Biller J, et al. Measurements of acute cerebral infarction: a clinical examination scale. Stroke. 1989;20(7):864-70.
28. Medical Research Council (MRC). Cluster randomised trials: methodological and ethical considerations. London: MRC; November 2002. http://www.cebma.org/wp-content/uploads/Cluster-randomised-trials-Methodological-and-ethical-considerations.pdf . Accessed 27 May 2015.
29. Eldridge S, Kerry S. A practical guide to cluster randomised trials in health services research. Chichester, UK: John Wiley & Sons; 2012.
30. Saver JL. Optimal end points for acute stroke therapy trials: best ways to measure treatment effects of drugs and devices. Stroke. 2011;42(8):2356-62.
31. American Thoracic Society, Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005;171(4):388-416.
32. National Stroke Foundation. National Stroke Audit - acute services organisational survey report 2013. http://www.pdfdrive.net/organisational-survey-report-2013-national-stroke-foundation-e12333650.html . Melbourne, Australia: National Stroke Foundation; October 2013. Accessed 27 May 2015.
33. Redfern J, Hyun K, Chew DP, Astley C, Chow C, Aliprandi-Costa B, et al. Prescription of secondary prevention medications, lifestyle advice, and referral to rehabilitation among acute coronary syndrome inpatients: results from a large prospective audit in Australia and New Zealand. Heart. 2014;100(16):1281-8.
34. Delcourt C, Hackett M, Wu Y, Huang Y, Wang J, Heeley E, et al. Determinants of quality of life after stroke in China: the ChinaQUEST (QUality Evaluation of Stroke care and Treatment) study. Stroke. 2011;42(2):433-8.
35. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH): Clinical safety data management: definitions and standards for expedited reporting (ICH harmonised tripartite guideline E2A). Step 4 version; 27 Oct 1994. http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html . Accessed 27 May 2015.
36. Wojner AW, El-Mitwalli A, Alexandrov AV. Effect of head positioning on intracranial blood flow velocities in acute ischemic stroke: a pilot study. Crit Care Nurs Q. 2002;24(4):57-66.
37. Wojner-Alexander AW, Garami Z, Chernyshev OY, Alexandrov AV. Heads down: flat positioning improves blood flow velocity in acute ischemic stroke. Neurology. 2005;64(8):1354-7.
38. Hunter AJ, Snodgrass SJ, Quain D, Parsons MW, Levi CR. HOBOE (Head-of-Bed Optimization of Elevation) Study: association of higher angle with reduced cerebral blood flow velocity in acute ischemic stroke. Phys Ther. 2011;91(10):1503-12.
39. Strbian D, Atula S, Meretoja A, Kaste M. Tatlisumak T; Helsinki Stroke Thrombolysis Registry Group. Outcome of ischemic stroke patients with serious post-thrombolysis neurological deficits Acta Neurol Scand. 2013;127(4):221-6.
40. Olavarría V, Lavados PM. The distribution of Modified Rankin scale scores change according to eligibility criteria in acute ischemic stroke trials. The European Stroke Organisation Conference 17-19 April 2015, date presented 17 April, Glasgow, United Kingdom. Abstract number 139
41. Middleton S, McElduff P, Ward J, Grimshaw JM, Dale S, D'Este C, et al. Implementation of evidence-based treatment protocols to manage fever, hyperglycaemia, and swallowing dysfunction in acute stroke (QASC): a cluster randomised controlled trial. Lancet. 2011;378(9804):1699-706.
42. Whitehead J. Sample size calculations for ordered categorical data. Stat Med. 1993;12(24):2257-71.
43. The Optimising Analysis of Stroke Trials (OAST) collaboration. Calculation of sample size for stroke trials assessing functional outcome: comparison of binary and ordinal approaches. Int J Stroke. 2008;3(2):78-84.
44. Wei JW, Arima H, Huang Y, Wang JG, Yang Q, Liu Z, et al. Variation in the frequency of intracerebral haemorrhage and ischaemic stroke in China: a national, multicentre, hospital register study. Cerebrovasc Dis. 2010;29(4):321-7.
45. Kerr DM, Fulton RL, Lees KR. Seven-day NIHSS is a sensitive outcome measure for exploratory clinical trials in acute stroke: evidence from the Virtual International Stroke Trials Archive. Stroke. 2012;43(5):1401-3.
46. Lin DY, Wei LJ. The robust inference for the Cox proportional hazard model. J Am Stat Assoc. 1989;84:1074-8.
47. Oakley A, Strange V, Bonell C, Allen E. Stephenson J; RIPPLE Study Team. Process evaluation in randomised controlled trials of complex interventions BMJ. 2006;332(7538):413-6.
48. Craig P, Petticrew M. Developing and evaluating complex interventions: reflections on the 2008 MRC guidance. Int J Nurs Stud. 2013;50(5):585-7.
49. Durlak JA, DuPre EP. Implementation matters: a review of research on the influence of implementation on program outcomes and the factors affecting implementation. Am J Community Psychol. 2008;41(3-4):327-50.
50. Dane AV, Schneider BH. Program integrity in primary and early secondary prevention: are implementation effects out of control? Clin Psychol Rev. 1998;18(1):23-45.
51. Grol R. Implementation of changes in practice. In: Grol R, Wensing M, Eccles M, editors. Improving patient care: the implementation of change in clinical practice. Edinburgh: Elsevier Butterworth Heinemann; 2005. p. 6-15.
52. Shuaib A, Butcher K, Mohammad AA, Saqqur M, Liebeskind DS. Collateral blood vessels in acute ischaemic stroke: a potential therapeutic target. Lancet Neurol. 2011;10(10):909-21.
53. Lima FO, Furie KL, Silva GS, Lev MH, Camargo EC, Singhal AB, et al. The pattern of leptomeningeal collaterals on CT angiography is a strong predictor of long-term functional outcome in stroke patients with large vessel intracranial occlusion. Stroke. 2010;41(10):2316-22.
54. Bang OY, Saver JL, Kim SJ, Kim GM, Chung CS, Ovbiagele B, et al. Collateral flow predicts response to endovascular therapy for acute ischemic stroke. Stroke. 2011;42(3):693-9.
55. Alexandrov AW, Ribo M, Wong KS, Sugg RM, Garami Z, Jesurum JT, et al. Perfusion augmentation in acute stroke using mechanical counter-pulsation-phase IIa: effect of external counterpulsation on middle cerebral artery mean flow velocity in five healthy subjects. Stroke. 2008;39(10):2760-4.
56. Saqqur M, Ibrahim M, Butcher K, Khan K, Emery D, Manawadu D, et al. Transcranial Doppler and cerebral augmentation in acute ischemic stroke. J Neuroimaging. 2013;23(3):460-5.