The SOS pilot study: A RCT of routine Oxygen supplementation early after acute stroke-effect on recovery of neurological function at one week

PLoS ONE

Volumn 6, Issue 5, 2011, Pages

  Roffe, Christine ^a,b   Ali, Khalid ^c   Warusevitane, Anushka ^a   Sills, Sheila ^a   Pountain, Sarah ^a   Allen, Martin ^d   Hodsoll, John ^a   Lally, Frank ^b   Jones, Peter ^e   Crome, Peter ^e  

^a Staffordshire   (United Kingdom)

^b KEELE UNIVERSITY   (United Kingdom)

^c BRIGHTON AND SUSSEX MEDICAL SCHOOL   (United Kingdom)

^d UNIVERSITY HOSPITAL OF NORTH STAFFORDSHIRE   (United Kingdom)

^e KEELE UNIVERSITY   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

OXYGEN;

ACUTE DISEASE; AGED; AMBIENT AIR; ARTICLE; BRAIN HYPOXIA; CONTROLLED STUDY; CONVALESCENCE; DRUG EFFECT; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; NATIONAL INSTITUTES OF HEALTH STROKE SCALE; OXYGEN SATURATION; OXYGEN THERAPY; PILOT STUDY; RANDOMIZED CONTROLLED TRIAL; SINGLE BLIND PROCEDURE; STROKE; TREATMENT OUTCOME; ANOXIA; BLOOD; BRAIN ISCHEMIA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; HOSPITALIZATION; INTERVENTION STUDY; NERVOUS SYSTEM FUNCTION; OXIMETRY; TIME;

AGED; ANOXIA; BRAIN ISCHEMIA; FEMALE; HOSPITALIZATION; HUMANS; INTERVENTION STUDIES; MALE; NERVOUS SYSTEM PHYSIOLOGICAL PHENOMENA; OXIMETRY; OXYGEN; OXYGEN INHALATION THERAPY; PILOT PROJECTS; RECOVERY OF FUNCTION; SINGLE-BLIND METHOD; STROKE; TIME FACTORS; TREATMENT OUTCOME;

EID: 79956327274     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0019113     Document Type: Article

References (49)

1. Sulter G, Elting JW, Stewart R, Arend A, De Keyser J, (2000) Continuous pulse oximetry in acute hemiparetic stroke. Journal of the neurological sciences 179 (1): 65-69.
2. Roffe C, Sills S, Halim M, Wilde K, Allen MB, et al. (2003) Unexpected Nocturnal Hypoxia in Patients With Acute Stroke. Stroke 34 (11): 2641-2645.
3. Silva Y, Puigdemont M, Castellanos M, Serena J, Suner RM, et al. (2005) Semi-intensive monitoring in acute stroke and long-term outcome. Cerebrovasc Dis 19 (1): 23-30.
4. Rowat AM, Dennis MS, Wardlaw JM, (2006) Hypoxaemia in acute stroke is frequent and worsens outcome. Cerebrovasc Dis 21 (3): 166-172.
5. Lewis L, Ponten U, Siesjo B, (1973) Homeostatic regulation of brain energy metabolism in hypoxia. Acta Physiol Scand 88 (2): 284-286.
6. Nakajima S, Meyer JS, Amano T, Shaw T, Okabe T, et al. (1983) Cerebral vasomotor responsiveness during 100% oxygen inhalation in cerebral ischemia. Arch Neurol 40 (5): 271-276.
7. Yager JY, Thornhill JA, (1997) The Effect of Age on Susceptibility to Hypoxic-Ischemic Brain Damage. Neuroscience & Biobehavioral Reviews 21 (2): 167-174.
8. Yamamoto M, Meyer JS, Sakai F, Yamaguchi F, (1980) Aging and cerebral vasodilator responses to hypercarbia: responses in normal aging and in persons with risk factors for stroke. Arch.Neurol 37 (8): 489-496.
9. Silva Y, Serena J, Osuna T, Castellanos M, Suner RM, et al. (2001) Hypoxaemia as an early predictor of progressing stroke and poor outcome in the acute phase. Cerebrovasc Dis 11 (S14): 70.
10. Rocco A, Pasquini M, Cecconi E, Sirimarco G, Ricciardi MC, et al. (2007) Monitoring After the Acute Stage of Stroke: A Prospective Study. Stroke 38 (4): 1225-1228.
11. Stroke Unit Trialists' Collaboration (2007) Organised inpatient (stroke unit) care for stroke. Cochrane Database Syst.Rev 4 pp. CD000197.
12. Sulter G, Elting JW, Langedijk M, Maurits NM, De Keyser J, (2003) Admitting Acute Ischemic Stroke Patients to a Stroke Care Monitoring Unit Versus a Conventional Stroke Unit: A Randomized Pilot Study. Stroke 34 (1): 101-104.
13. Indredavik B, Bakke F, Slordahl S, Rokseth R, Haheim L, (1999) Treatment in a Combined Acute and Rehabilitation Stroke Unit: Which Aspects Are Most Important? Stroke 30 (5): 917-923.
14. Bateman N, Leach R, (1998) ABC of Oxygen: Acute oxygen therapy. BMJ 317 (7161): 798-801.
15. Roffe C, Thakkar A, (2009) Diagnosis and management of hypoxia after acute stroke. CME Journal Geriatric Medicine 11: 3-8.
16. McCord JM, (1985) Oxygen-derived free radicals in postischemic tissue injury. N Engl J Med 312 (3): 159-163.
17. Kontos HA, (2001) Oxygen Radicals in Cerebral Ischemia: The 2001 Willis Lecture. Stroke 32 (11): 2712-2716.
18. Mattson MP, Culmsee C, Yu ZF, (2000) Apoptotic and antiapoptotic mechanisms in stroke. Cell Tissue Res 301 (1): 173-187.
19. Sugawara T, Fujimura M, Noshita N, Kim GW, Saito A, et al. (2004) Neuronal Death/Survival Signaling Pathways in Cerebral Ischemia. NeuroRX 1 (1): 17-25.
20. Chan PH, (1996) Role of Oxidants in Ischemic Brain Damage. Stroke 27 (6): 1124-1129.
21. Sims NR, Anderson MF, (2002) Mitochondrial contributions to tissue damage in stroke. Neurochemistry International 40 (6): 511-526.
22. Crack PJ, Taylor JM, (2005) Reactive oxygen species and the modulation of stroke. Free Radical Biology and Medicine 38 (11): 1433-1444.
23. Flynn E, Auer R, (2002) Eubaric hyperoxemia and experimental cerebral infarction. Ann.Neurol 52 (5): 566-572.
24. Liu S, Liu W, Ding W, Miyake M, Rosenberg GA, et al. (2006) Electron paramagnetic resonance-guided normobaric hyperoxia treatment protects the brain by maintaining penumbral oxygenation in a rat model of transient focal cerebral ischemia. J Cereb Blood Flow Metab 26 (10): 1274-1284.
25. Singhal AB, Wang X, Sumii T, Mori T, Lo EH, (2002) Effects of Normobaric Hyperoxia in a Rat Model of Focal Cerebral Ischemia-Reperfusion. J Cereb Blood Flow Metab 22 (7): 861-868.
26. Ronning OM, Guldvog B, (1999) Should Stroke Victims Routinely Receive Supplemental Oxygen?: A Quasi-Randomized Controlled Trial. Stroke 30 (10): 2033-2037.
27. Singhal AB, Benner T, Roccatagliata L, Koroshetz WJ, Schaefer PW, et al. (2005) A Pilot Study of Normobaric Oxygen Therapy in Acute Ischemic Stroke. Stroke 36 (4): 797-802.
28. Wijesinghe M, Perrin K, Ranchord A, Simmonds M, Weatherall M, et al. (2009) Routine use of oxygen in the treatment of myocardial infarction: systematic review. Heart 95 (3): 198-202.
29. Roffe C, Sills S, Pountain S, Allen M, (2010) A Randomized Controlled Trial of the Effect of Fixed-dose Routine Nocturnal Oxygen Supplementation on Oxygen Saturation in Patients with Acute Stroke. Journal of Stroke and Cerebrovascular Diseases 19 (1): 29-35.
30. Adams HP Jr, del Zoppo G, Alberts MJ, Bhatt DL, Brass L, et al. (2007) Guidelines for the Early Management of Adults With Ischemic Stroke: A Guideline From the American Heart Association/American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups: The American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists. Stroke 38 (5): 1655-1711.
31. European Stroke Organization Guidelines for the management of ischaemic stroke and transient ischaemic attack. European Stroke Organization (Accessed 6-2-2009).
32. Intercollegiate Stroke Working party National Clinical Guideline for Stroke. Royal College of Physicians (Accessed 6-2-2009).
33. Thorvaldsen P, Asplund K, Kuulasmaa K, Rajakangas AM, Schroll M, (1995) Stroke Incidence, Case Fatality, and Mortality in the WHO MONICA Project. Stroke 26 (3): 361-367.
34. Ali K, Sills S, Roffe C, (2005) The effect of different doses of oxygen administration on oxygen saturation in patients with stroke. Neurocrit Care 3 (1): 24-26.
35. Bamford J, Sandercock P, Dennis M, Warlow C, Burn J, (1991) Classification and natural history of clinically identifiable subtypes of cerebral infarction. The Lancet 337 (8756): 1521-1526.
36. Brott T, Adams H Jr, Olinger C, Marler JR, Barsan W, et al. (1989) Measurements of acute cerebral infarction: a clinical examination scale. Stroke 20 (7): 864-870.
37. (1985) Multicenter trial of hemodilution in ischemic stroke--background and study protocol. Scandinavian Stroke Study Group. Stroke 16 (5): 885-890.
38. Roffe C, Sills S, Wilde K, Crome P, (2001) Effect of Hemiparetic Stroke on Pulse Oximetry Readings on the Affected Side. Stroke 32 (8): 1808-1810.
39. Wityk RJ, Pessin MS, Kaplan RF, Caplan LR, (1994) Serial assessment of acute stroke using the NIH Stroke Scale. Stroke 25 (2): 362-365.
40. Young FB, Weir CJ, Lees KR, for the GAIN International Trial Steering Committee and Investigators. (2005) Comparison of the National Institutes of Health Stroke Scale With Disability Outcome Measures in Acute Stroke Trials. Stroke 36 (10): 2187-2192.
41. Nuutinen J, Liu Y, Laakso MP, Karonen JO, Roivainen R, et al. (2006) Assessing the outcome of stroke: a comparison between MRI and clinical stroke scales. Acta Neurol Scand 113 (2): 100-107.
42. Appelros P, Terent A, (2004) Characteristics of the National Institute of Health Stroke Scale: results from a population-based stroke cohort at baseline and after one year. Cerebrovasc Dis 17 (1): 21-27.
43. Bruno A, Saha C, Williams LS, (2006) Using Change in the National Institutes of Health Stroke Scale to Measure Treatment Effect in Acute Stroke Trials. Stroke 37 (3): 920-921.
44. Schulz KF, Grimes DA, (2005) Multiplicity in randomised trials II: subgroup and interim analyses. The Lancet 365 (9471): 1657-1661 5-13-2005.
45. Bennett M, Wasiak J, Schnabel A, Kranke P, French C, (2005) Hyperbaric oxygen therapy for acute ischaemic stroke. Cochrane Database Syst Rev 3 pp. CD004954.
46. Koops L, Lindley R, (2002) Thrombolysis for acute ischaemic stroke: consumer involvement in design of new randomised controlled trial. BMJ 325 (7361): 415.
47. Ali K, Roffe C, Crome P, (2006) What Patients Want: Consumer Involvement in the Design of a Randomized Controlled Trial of Routine Oxygen Supplementation After Acute Stroke. Stroke 37 (3): 865-871.
48. BTS guideline for emergency oxygen use in adult patients. Thorax (Accessed 2-8-2009).
49. Roffe C, Crome, Peter, Gray R, Jones P, Handy P&L, The Stroke Oxygen Study. and http://www.so2s.co.uk/.