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

Janet E. Bray, Karen Smith, Cindy Hein, Judith Finn, Michael Stephenson, Peter Cameron, Dion Stub, Gavin D. Perkins, Hugh Grantham, Paul Bailey, Deon Brink, Natasha Dodge, Stephen Bernard

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Abstract

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 (SpO 2 ) ≥95% on >10 L/min (or 100% oxygen). Paramedics will randomise 1416 eligible cases to receive oxygen therapy targeting an SpO 2 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.

Original languageEnglish
Pages (from-to)208-213
Number of pages6
JournalResuscitation
Volume139
DOIs
Publication statusPublished - 1 Jun 2019

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Out-of-Hospital Cardiac Arrest
Oxygen
Survival
Resuscitation
Allied Health Personnel
Hyperoxia
South Australia
Victoria
Coma
Heart Arrest
Intensive Care Units
Quality of Life
Wounds and Injuries
Therapeutics
Research

Cite this

Bray, Janet E. ; Smith, Karen ; Hein, Cindy ; Finn, Judith ; Stephenson, Michael ; Cameron, Peter ; Stub, Dion ; Perkins, Gavin D. ; Grantham, Hugh ; Bailey, Paul ; Brink, Deon ; Dodge, Natasha ; Bernard, Stephen. / 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. In: Resuscitation. 2019 ; Vol. 139. pp. 208-213.
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abstract = "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 (SpO 2 ) ≥95{\%} on >10 L/min (or 100{\%} oxygen). Paramedics will randomise 1416 eligible cases to receive oxygen therapy targeting an SpO 2 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.",
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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 E.; Smith, Karen; Hein, Cindy; Finn, Judith; Stephenson, Michael; Cameron, Peter; Stub, Dion; Perkins, Gavin D.; Grantham, Hugh; Bailey, Paul; Brink, Deon; Dodge, Natasha; Bernard, Stephen.

In: Resuscitation, Vol. 139, 01.06.2019, p. 208-213.

Research output: Contribution to journalArticle

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T2 - 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

AU - Bray, Janet E.

AU - Smith, Karen

AU - Hein, Cindy

AU - Finn, Judith

AU - Stephenson, Michael

AU - Cameron, Peter

AU - Stub, Dion

AU - Perkins, Gavin D.

AU - Grantham, Hugh

AU - Bailey, Paul

AU - Brink, Deon

AU - Dodge, Natasha

AU - Bernard, Stephen

PY - 2019/6/1

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N2 - 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 (SpO 2 ) ≥95% on >10 L/min (or 100% oxygen). Paramedics will randomise 1416 eligible cases to receive oxygen therapy targeting an SpO 2 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.

AB - 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 (SpO 2 ) ≥95% on >10 L/min (or 100% oxygen). Paramedics will randomise 1416 eligible cases to receive oxygen therapy targeting an SpO 2 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.

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