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Access Document BMJ Confidential: For Review Only A Pragmatic, Cluster-Randomised Cross- Over Comparison of Two Oxygen Protocols in Patients with a Suspected Acute Coronary Syndrome Journal: BMJ Manuscript ID BMJ-2020-060486.R1 Article Type: Research BMJ Journal: BMJ Date Submitted by the 08-Oct-2020 Author: Complete List of Authors: Stewart, Ralph; Auckland City Hospital, Green Lane Cardiovascular Service; The University of Auckland Jones, Peter; Auckland City Hospital, and Department of Surgery, Emergency Medicine Department; The University of Auckland Dicker, Bridget; St John, Clinical Audit and Research; Auckland University of Technology, Paramedicine Jiang, Yannan; The University of Auckland National Institute for Health Innovation, Department of Statistics Smith, Tony; St John Ambulance, Clinical Audit and Research Swain, Andrew; Wellington Free Ambulance, Paramedicine; Auckland University of Technology, Paramedicine Kerr, Andrew; Middlemore Hospital, Department of Cardiology; The University of Auckland, Section of Epidemiology and Biostatistics Scott, Tony; North Shore Hospital, Department of Cardiology Smyth, David; Canterbury District Health Board, Department of Cardiology Ranchord, Anil; Capital and Coast District Health Board, Department of Cardiology Edmond, John; Southern District Health Board; University of Otago Faculty of Medicine Than, Martin; Christchurch Hospital, Emergency Medicine Webster, Mark; Auckland City Hospital, Green Lane Cardiovascular Service; The University of Auckland White, Harvey; Auckland City Hospital, Green Lane Cardiovascular Service; The University of Auckland Devlin, Gerard; Hauroa Tairāwhiti, Gisborne and Heart Foundation of New Zealand Keywords: Acute Coronary Syndrome, Oxygen, Pragmatic Clinical Trial https://mc.manuscriptcentral.com/bmj Page 1 of 49 BMJ 1 2 3 4 5 6 7 8 9 10 11 Confidential: For Review Only 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 https://mc.manuscriptcentral.com/bmj BMJ Page 2 of 49 1 2 3 1 A Pragmatic, Cluster-Randomised Cross- Over Comparison of Two Oxygen 4 5 6 2 Protocols in Patients with a Suspected Acute Coronary Syndrome 7 8 3 9 10 4 Ralph A H Stewart M.D., Peter Jones MB ChB, Bridget Dicker PhD, Yannan Jiang PhD, 11 12 5 Tony SmithConfidential: MB ChB, Andrew Swain PhD, Andrew For Kerr Review M.D., Tony Scott MB Only ChB, David Smyth M.D., 13 14 6 Anil Ranchord MB ChB, John Edmond M.D., Martin Than MBBS, Mark Webster MB ChB, 15 16 7 Harvey D White DSc, Gerard Devlin M.D 17 18 8 19 20 9 Green Lane Cardiovascular Services Auckland City Hospital (R.A.H.S, M.W., H.D.W.) 21 22 10 and University of Auckland (R.A.H.S., M.W., H.D.W.); Emergency Medicine Research, Auckland City 23 24 11 Hospital, and Department of Surgery, University of Auckland, (P.J.); St John Auckland & 25 26 12 Paramedicine Department, Auckland University of Technology (B.D.); National Institute for Health 27 28 13 Innovation, University of Auckland, Auckland (Y.J.); St John Ambulance, New Zealand (T.S.); 29 30 14 Wellington Free Ambulance, Wellington (A.S.); Department of Cardiology, Middlemore Hospital, 31 15 and Section of Epidemiology and Biostatistics, University of Auckland (A.K.); Cardiology Department, 32 33 16 Northshore Hospital (T.S.); Canterbury District Health Board, Christchurch (D.S.); 34 35 17 Cardiology Department, Capital & Coast District Health Board, Wellington Hospital (A.R.); 36 37 18 Southern District Health Board, Dunedin and Dunedin School of Medicine, University of Otago, 38 39 19 Dunedin (J.E.); Department of Emergency Medicine, Christchurch Hospital (M.T.); 40 41 20 Hauroa Tairāwhiti, Gisborne and Heart Foundation of New Zealand (G.D.) 42 43 21 44 45 22 CORRESPONDING AUTHOR 46 47 23 Professor Ralph A.H. Stewart 48 49 24 Green Lane Cardiovascular Service, Auckland City Hospital 50 51 25 Private Bag 92024, 52 53 26 Auckland 1030, New Zealand 54 55 27 Phone +64-9-3074949 Ext 23668 56 57 28 Email [email protected] 58 59 29 Word count: 4476 (excluding title page, abstract, references, figures and tables) 60 1 | P a g e https://mc.manuscriptcentral.com/bmj Page 3 of 49 BMJ 1 2 3 1 ABSTRACT 4 5 2 6 7 3 Objective: To determine whether high flow supplementary oxygen influences 30 day mortality in 8 9 4 patients presenting with a suspected acute coronary syndrome (ACS). 10 11 5 Design: Pragmatic, cluster-randomized, cross-over trial. 12 Confidential: For Review Only 13 6 Setting: Two oxygen protocols were used as part of routine care in patients with suspected ACS in 14 15 7 ambulances and hospitals throughout New Zealand. All four New Zealand geographic regions were 16 17 8 randomly allocated to each oxygen protocol in 6 month blocks over 2 years. 18 19 9 Participants: 40,872 patients with suspected ACS included in the All NZ ACS-Quality Improvement 20 21 10 register or ambulance ACS pathway during the study periods, 4159 (10%) had a final diagnosis of 22 23 11 STEMI and 10,218 (25%) non-STEMI. 24 25 12 Interventions: The “high” oxygen protocol recommended oxygen at 6-8 litres/minute by face mask for 26 13 ischaemic symptoms or electrocardiographic changes, irrespective of the oxygen saturation (SpO ). 27 2 28 14 The “low” oxygen protocol recommended oxygen only if SpO was <90%, with a target SpO <95%. 29 2 2 30 15 Main outcome measure: 30 day all cause mortality determined from linkage to administrative data. 31 32 16 Results: Demographic and clinical characteristics of patients managed under the high (n=20,304) 33 34 17 and the low oxygen (n=20,568) protocols were well matched. For all patients with suspected ACS 30 35 36 18 day mortality for the high and low oxygen groups respectively was 613 (3.0%) versus 642 (3.1%), 37 38 19 odds ratio [OR] 0.97, 95% CI 0.86, 1.08. In patients with STEMI 30 day mortality for the high and low 39 40 20 protocols was 178 (8.8%) and 225 (10.6%) respectively, OR 0.81, 95% CI 0.66, 1.00, and for patients 41 42 21 with non-STEMI high 187 (3.6%) and low 176 (3.5%), OR 1.05, 95% CI 0.85, 1.29. 43 44 22 Conclusion: High flow oxygen did not increase or decrease 30 day mortality in a large patient cohort 45 46 23 presenting with suspected ACS. 47 48 24 49 25 Trial Registration: ANZ Clinical Trials Website (ACTRN12616000461493); 50 51 26 https://www.anzctr.org.au/Default.aspx 52 53 27 Keywords: acute coronary syndromes, oxygen, pragmatic clinical trial 54 55 28 Abstract Word Count: 276 56 57 58 59 60 2 | P a g e https://mc.manuscriptcentral.com/bmj BMJ Page 4 of 49 1 2 3 1 INTRODUCTION 4 5 2 Oxygen has been given to patients with acute myocardial infarction for over 50 years, despite limited 6 7 3 evidence that this improves outcomes.(1) Supplementary oxygen can correct or reduce hypoxemia, 8 9 4 which is common in patients with acute coronary syndromes. However there is some evidence that 10 11 5 arterial oxygen saturation levels above normal could be harmful by causing coronary vasoconstriction 12 Confidential: For Review Only 13 6 or increasing oxidative stress.(1, 2) The possibility of harm from supplementary oxygen was 14 15 7 supported by a meta-analysis of clinical trials which compared liberal with conservative oxygen 16 17 8 strategies in predominantly normoxemic patients with a range of critical medical conditions.(3) The 18 19 9 only previous large, randomised trial in patients with suspected myocardial infarction, ‘DETO2X-AMI’, 20 21 10 reported no difference in one year mortality in patients given 12 hours of high flow oxygen, compared 22 23 11 to limited oxygen.(4) Current clinical practice guidelines recommend that oxygen is not given to 24 25 12 patients with ST elevation myocardial infarction (STEMI) or non-STEMI who are not hypoxemic.(5-9) 26 13 27 28 14 There are limitations with the available evidence. First, patients included in randomised trials 29 30 15 generally have a lower risk and may not be representative of all patients managed in usual care. 31 32 16 Second, all previous trials including DETO2X-AMI, had insufficient power to identify a small, but 33 34 17 clinically relevant, 1-2% absolute difference in mortality with oxygen treatment. Third, most patients 35 36 18 included in previous trials had normal oxygen saturation levels. A benefit from oxygen may require the 37 38 19 presence of hypoxemia. The saturation threshold for starting oxygen (e.g. <95% or <90%), and the 39 40 20 target oxygen saturation level when on oxygen, are uncertain. Fourth, it is possible the effects of 41 42 21 oxygen depend upon the diagnosis. For example, patients having an acute STEMI typically have 43 44 22 prolonged and severe myocardial ischemia, and may show greater benefit than those with other 45 46 23 conditions. 47 48 24 49 25 Recommendations for treating hypoxaemia would be better informed if there was clear evidence on 50 51 26 whether there is harm from high flow oxygen, suggesting that high SpO need to be avoided, or 52 2 53 27 evidence there was benefit from giving oxygen to correct modest reductions in SpO . To determine 54 2 55 28 whether and when oxygen may be indicated in patients with a suspected ACS we undertook a 56 57 29 pragmatic, randomised comparison of ‘high’ and ‘low’ oxygen delivery strategies as part of usual care 58 59 60 3 | P a g e https://mc.manuscriptcentral.com/bmj Page 5 of 49 BMJ 1 2 3 1 in a large cohort of patients presenting to ambulances and acute cardiac care units thoughout New 4 5 2 Zealand (NZ) over 2 years.
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