The EXACT protocol: A multi-centre, single-blind, randomised, parallel-group, controlled trial to determine whether early oxygen titration improves survival to hospital discharge in adult OHCA patients
Background: Experimental and observational research suggests hyperoxia following resuscitation from cardiac arrest is associated with neurological injury and worse clinical outcomes. This paper describes the rationale and design of the EXACT trial. EXACT aims to determine whether reducing oxygen in...
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| Format: | Journal Article |
| Language: | English |
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ELSEVIER IRELAND LTD
2019
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| Online Access: | http://hdl.handle.net/20.500.11937/79488 |
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| author | Bray, Janet Smith, K. Hein, C. Finn, Judith Stephenson, M. Cameron, P. Stub, D. Perkins, G.D. Grantham, H. Bailey, P. Brink, D. Dodge, N. Bernard, S. |
| author_facet | Bray, Janet Smith, K. Hein, C. Finn, Judith Stephenson, M. Cameron, P. Stub, D. Perkins, G.D. Grantham, H. Bailey, P. Brink, D. Dodge, N. Bernard, S. |
| author_sort | Bray, Janet |
| building | Curtin Institutional Repository |
| collection | Online Access |
| description | Background: Experimental and observational research suggests hyperoxia following resuscitation from cardiac arrest is associated with neurological injury and worse clinical outcomes. This paper describes the rationale and design of the EXACT trial. EXACT aims to determine whether reducing oxygen in the acute phase of post-resuscitation care for out-of-hospital cardiac arrest (OHCA) improves survival. Methods: EXACT is a multi-centre, randomised (1:1), single-blind, parallel trial. Presumed cardiac OHCA cases who achieve a return of spontaneous circulation will be eligible if they are comatose, with an advanced airway and have an oxygen saturation (SpO2) ≥95% on >10 L/min (or 100% oxygen). Paramedics will randomise 1416 eligible cases to receive oxygen therapy targeting an SpO2 of 90–94% (intervention) or 98–100% (control). Study treatment will continue until admission to an intensive care unit or hospital ward. The primary outcome is survival to hospital discharge. Secondary outcomes include 12-month survival and quality of life. Results: The study has commenced in the Australian states of Victoria and South Australia, and has enrolled 167 eligible cases to date (80 intervention and 87 control). Further sites are due to commence in 2019, recruitment is expected to take three years. Conclusion: This study will determine if early reduction of oxygen leads to improved outcomes in OHCA. Such a finding may potentially change clinical practice with implications on future OHCA survival outcomes. Trial registration number: NCT03138005. |
| first_indexed | 2025-11-14T11:13:19Z |
| format | Journal Article |
| id | curtin-20.500.11937-79488 |
| institution | Curtin University Malaysia |
| institution_category | Local University |
| language | English |
| last_indexed | 2025-11-14T11:13:19Z |
| publishDate | 2019 |
| publisher | ELSEVIER IRELAND LTD |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | curtin-20.500.11937-794882020-08-07T03:46:52Z The EXACT protocol: A multi-centre, single-blind, randomised, parallel-group, controlled trial to determine whether early oxygen titration improves survival to hospital discharge in adult OHCA patients Bray, Janet Smith, K. Hein, C. Finn, Judith Stephenson, M. Cameron, P. Stub, D. Perkins, G.D. Grantham, H. Bailey, P. Brink, D. Dodge, N. Bernard, S. Science & Technology Life Sciences & Biomedicine Critical Care Medicine Emergency Medicine General & Internal Medicine Oxygen Hyperoxia Out-of-hospital cardiac arrest Heart arrest Post-resuscitation care HEART-ASSOCIATION GUIDELINES CARDIAC-ARREST CARDIOPULMONARY-RESUSCITATION THERAPEUTIC HYPOTHERMIA REPERFUSION INJURY INDUCTION HYPEROXIA METAANALYSIS CARE Background: Experimental and observational research suggests hyperoxia following resuscitation from cardiac arrest is associated with neurological injury and worse clinical outcomes. This paper describes the rationale and design of the EXACT trial. EXACT aims to determine whether reducing oxygen in the acute phase of post-resuscitation care for out-of-hospital cardiac arrest (OHCA) improves survival. Methods: EXACT is a multi-centre, randomised (1:1), single-blind, parallel trial. Presumed cardiac OHCA cases who achieve a return of spontaneous circulation will be eligible if they are comatose, with an advanced airway and have an oxygen saturation (SpO2) ≥95% on >10 L/min (or 100% oxygen). Paramedics will randomise 1416 eligible cases to receive oxygen therapy targeting an SpO2 of 90–94% (intervention) or 98–100% (control). Study treatment will continue until admission to an intensive care unit or hospital ward. The primary outcome is survival to hospital discharge. Secondary outcomes include 12-month survival and quality of life. Results: The study has commenced in the Australian states of Victoria and South Australia, and has enrolled 167 eligible cases to date (80 intervention and 87 control). Further sites are due to commence in 2019, recruitment is expected to take three years. Conclusion: This study will determine if early reduction of oxygen leads to improved outcomes in OHCA. Such a finding may potentially change clinical practice with implications on future OHCA survival outcomes. Trial registration number: NCT03138005. 2019 Journal Article http://hdl.handle.net/20.500.11937/79488 10.1016/j.resuscitation.2019.04.023 English ELSEVIER IRELAND LTD restricted |
| spellingShingle | Science & Technology Life Sciences & Biomedicine Critical Care Medicine Emergency Medicine General & Internal Medicine Oxygen Hyperoxia Out-of-hospital cardiac arrest Heart arrest Post-resuscitation care HEART-ASSOCIATION GUIDELINES CARDIAC-ARREST CARDIOPULMONARY-RESUSCITATION THERAPEUTIC HYPOTHERMIA REPERFUSION INJURY INDUCTION HYPEROXIA METAANALYSIS CARE Bray, Janet Smith, K. Hein, C. Finn, Judith Stephenson, M. Cameron, P. Stub, D. Perkins, G.D. Grantham, H. Bailey, P. Brink, D. Dodge, N. Bernard, S. The EXACT protocol: A multi-centre, single-blind, randomised, parallel-group, controlled trial to determine whether early oxygen titration improves survival to hospital discharge in adult OHCA patients |
| title | The EXACT protocol: A multi-centre, single-blind, randomised, parallel-group, controlled trial to determine whether early oxygen titration improves survival to hospital discharge in adult OHCA patients |
| title_full | The EXACT protocol: A multi-centre, single-blind, randomised, parallel-group, controlled trial to determine whether early oxygen titration improves survival to hospital discharge in adult OHCA patients |
| title_fullStr | The EXACT protocol: A multi-centre, single-blind, randomised, parallel-group, controlled trial to determine whether early oxygen titration improves survival to hospital discharge in adult OHCA patients |
| title_full_unstemmed | The EXACT protocol: A multi-centre, single-blind, randomised, parallel-group, controlled trial to determine whether early oxygen titration improves survival to hospital discharge in adult OHCA patients |
| title_short | The EXACT protocol: A multi-centre, single-blind, randomised, parallel-group, controlled trial to determine whether early oxygen titration improves survival to hospital discharge in adult OHCA patients |
| title_sort | exact protocol: a multi-centre, single-blind, randomised, parallel-group, controlled trial to determine whether early oxygen titration improves survival to hospital discharge in adult ohca patients |
| topic | Science & Technology Life Sciences & Biomedicine Critical Care Medicine Emergency Medicine General & Internal Medicine Oxygen Hyperoxia Out-of-hospital cardiac arrest Heart arrest Post-resuscitation care HEART-ASSOCIATION GUIDELINES CARDIAC-ARREST CARDIOPULMONARY-RESUSCITATION THERAPEUTIC HYPOTHERMIA REPERFUSION INJURY INDUCTION HYPEROXIA METAANALYSIS CARE |
| url | http://hdl.handle.net/20.500.11937/79488 |