Out-of-Hospital Cardiac ArrestEXACTNCT03138005
Reduction of Oxygen After Cardiac Arrest
A study testing target SpO2 98-100% and target SpO2 90-94% in people with Out-of-Hospital Cardiac Arrest, run by Monash University at 21 sites in Australia.
Trial summary
The Reduction of oxygen after cardiac arrest (EXACT) is a multi-centre, randomised, controlled trial (RCT) to determine whether reducing oxygen administration to target an oxygen saturation of 90-94%, compared to 98-100%, as soon as possible following successful resuscitation from OHCA improves outcome at hospital… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-of-Hospital Cardiac Arrest
- What is being tested?
- target SpO2 98-100% and target SpO2 90-94%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 428 participants
- Where
- 21 sitesAustralia
- Study dates
- 11 Dec 2017to 5 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (age 18 years or older)
- Out-of-hospital cardiac arrest of presumed cardiac cause
- All cardiac arrest rhythms
- Unconscious (Glasgow Coma Scale <9)
- Return of spontaneous circulation
- Pulse oximeter measures oxygen saturation at ≥95% with oxygen flow set at >10L/min or FiO2 at 100%
- Patient has an endotracheal tube (ETT) or supraglottic airway (SGA) (e.g. laryngeal mask airway -LMA) and is spontaneously breathing or ventilated
- Transport is planned to a participating hospital
Who cannot join
- Female who is known or suspected to be pregnant
- Dependent on others for activities of daily living (i.e. facilitated care or nursing home residents)
- "Not for Resuscitation" order or Advanced Care Directives in place
- Pre-existing oxygen therapy (i.e. for COPD)
- Cardiac arrest due to drowning, trauma or hanging
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Australia21 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
The Queen Elizabeth Hospital
Adelaide, South Australia, 5011
SA Ambulance Service
Adelaide, South Australia, 5063
Lyell McEwin Hospital
Adelaide, South Australia, 5112
Alfred Hospital
Melbourne, Victoria, 3004
Western Health: Footscray Hospital
Melbourne, Victoria, 3011
Western Health: Sunshine Hospital
Melbourne, Victoria, 3021
The Royal Melbourne Hospital
Melbourne, Victoria, 3050
St Vincents Hospital
Melbourne, Victoria, 3065
Northern Health: The Northern Hospital
Melbourne, Victoria, 3076
Austin Hospital
Melbourne, Victoria, 3084
Box Hill Hospital
Melbourne, Victoria, 3128
Ambulance Victoria
Melbourne, Victoria, 3130
Eastern Health: Maroondah Hospital
Melbourne, Victoria, 3135
Monash Medical Centre
Melbourne, Victoria, 3168
Peninusla Health: Frankston Hospital
Melbourne, Victoria, 3199
Barwon Health: Geelong
Melbourne, Victoria, 3220
Royal Perth Hospital
Perth, Western Australia, 6000
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009
Fiona Stanley Hospital
Perth, Western Australia, 6150
St John Ambulance Western Australia
Perth, Western Australia, 6984
About this study
Official title: Reduction of Oxygen After Cardiac Arrest (EXACT): The EXACT Study
The Reduction of oxygen after cardiac arrest (EXACT) is a multi-centre, randomised, controlled trial (RCT) to determine whether reducing oxygen administration to target an oxygen saturation of 90-94%, compared to 98-100%, as soon as possible following successful resuscitation from OHCA improves outcome at hospital discharge.
Read the detailed description
Currently out-of-hospital cardiac arrest (OHCA) patients who achieve ROSC are routinely ventilated with the highest fraction of inspired oxygen (FiO2) possible (i.e. FiO2 1.0 or 100% oxygen) until admission to an intensive care unit (ICU) - usually a period of 2 to 6 hours post-ROSC.
Post-ROSC oxygen therapy begins in the field by emergency medical services (EMS). EMS typically deliver a high flow of oxygen at rate of >10L/min (~100% oxygen), and use a pulse oximeter to monitor oxygen levels (SpO2). Normal SpO2 levels are considered to be 94% to 100%. The delivery of 100% oxygen is then usually continued throughout a patient's stay in the emergency department (ED) and during any diagnostic testing (e.g. computed tomography scans and cardiac angiography). During this time, oxygen is delivered to patients who remain unconscious via a mechanical ventilator, with levels continuously monitored by pulse oximetry and periodically by a blood test called an arterial blood gas (ABG). The ABG measurements include the oxygen pressure in the blood (PaO2) in mmHg. Once a patient is admitted to the ICU, the PaO2 is assessed and the oxygen fraction is typically reduced and then titrated (reduced or increased) on the ventilator to achieve a normal level of PaO2 ("normoxia") of between 80-100mmHg.
The administration of 100% oxygen for the first hours after resuscitation is based largely on convention and not on any supportive clinical data. It has been thought that maximizing oxygen delivery for several hours might be beneficial in a patient who has suffered profound deprivation of oxygen supply ("hypoxia") during a cardiac arrest. In addition, if a lower fraction of inspired oxygen is delivered, there is a perceived risk that the patient might become hypoxic (i.e. SpO2 <90% or PaO2 <80mmHg). Until recently, there has been no particular reason to recommend a decrease in oxygen delivery to the post-arrest patient prior to admission to ICU.
However, recent systematic reviews of compelling experimental data and supportive human observational studies indicate that the administration of 100% oxygen can create "hyperoxic" levels in the early post arrest period which may lead to additional neurological injury, and thus result in worse clinical outcome. No randomised control trials have yet tested titrating oxygen administration to lower but normal levels (i.e. "normoxia").
EXACT is a Phase 3 multi-centre, randomised, controlled trial (RCT) aiming to determine whether reducing oxygen administration to target an oxygen saturation of 90-94%, compared to 98-100%, as soon as possible following successful resuscitation from OHCA improves outcome at hospital discharge.
- Conditions
- Out-of-Hospital Cardiac Arrest
- Being tested
- target SpO2 98-100%, target SpO2 90-94%
- Keywords
- Emergency Care, Prehospital, Resuscitation, Oxygen, Cardiac Arrest, Heart Arrest
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
target SpO2 98-100%Other
Prehospital, post-ROSC oxygen maintained at ≥10L/minute of oxygen (equivalent to ~100% oxygen) into SGA/ETT if hand ventilated or 100% (i.e. FiO2 of 1.0) oxygen settings if mechanically ventilated. Patients will continue on treatment to handover in the ED. Between arrival at ED and first ABG in ICU, the oxygen setting may then be decreased provided SpO2 is maintained between 98-100%.
target SpO2 90-94%Other
Prehospital, post-ROSC oxygen reduced initially to 4L/minute (i.e. approximately 70% oxygen) into SGA/ETT if hand ventilated or an air mix setting if mechanically ventilated. If oxygen saturation remains ≥94% for 5 minutes, the oxygen flow rate will be further reduced to 2L/minute (i.e. approximately 46% oxygen) and hand ventilated to target an oxygen saturation between 90-94%. This treatment will continue to patient handover in the emergency department. Between arrival at ED and first ABG in ICU, oxygen will be titrated to target a oxygen saturation of 90-94%.
| Study group | Role | What they receive |
|---|---|---|
| target SpO2 98-100% | Active comparator | Post ROSC oxygen titrated to maintain SpO2 between 98-100% Receives: Other: target SpO2 98-100% |
| target SpO2 90-94% | Experimental | Post ROSC oxygen titrated to maintain SpO2 between 90-94% Receives: Other: target SpO2 90-94% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival to hospital discharge
Survival to hospital discharge
Measured: At hospital discharge, participants will be followed for the duration of hospital stay, an expected average of 2-4 weeks
Secondary outcomes (13)
Neurological outcome
Cerebral Performance Category score
Measured: At hospital discharge, participants will be followed for the duration of hospital stay, an expected average of 2-4 weeks
Incidence of hypoxia (SpO2<90%)
Incidence of hypoxia (SpO2<90%)
Measured: Before ICU admission, an expected average of 4-6 hours
Recurrent cardiac arrest
Recurrent cardiac arrest requiring chest compressions before admission to ICU and not related to withdrawal of life sustaining-treatment
Measured: Before ICU admission, an expected average of 4-6 hours
Myocardial Injury
Median peak troponin
Measured: First 24 hours of hospital admission
Survival to intensive care unit discharge
Survival to intensive care unit discharge
Measured: Intensive care discharge, an expected average of 7 days
Length of ICU stay
Length of ICU stay
Measured: Intensive care discharge, an expected average of 7 days
Length of hospital stay
Length of hospital stay
Measured: At hospital discharge, participants will be followed for the duration of hospital stay, an expected average of 2-4 weeks
Cause of death during hospital stay
e.g. cardiogenic shock, re-arrest with no ROSC, treatment withdrawn -hypoxic brain injury, brain death
Measured: At hospital discharge, participants will be followed for the duration of hospital stay, an expected average of 2-4 weeks
Quality of Life SF-12
The SF-12 Health Survey (SF-12) is a 12-item questionnaire used to assess health outcomes from the patient's perspective.
Measured: 12 months
Quality of Life EQ-5D-3L
Quality of life assessment using the EQ-5D-3L descriptive system that comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.
Measured: 12 months
Neurological Function
Modified Rankin Score
Measured: 12 months
Degree of recovery (GOS-E)
Extended Glasgow Outcome Scale
Measured: 12 months
Survival at 12 months
Survival at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start11 Dec 2017
- Primary completion5 Aug 2020
- Study completion5 Aug 2020
Why it stopped: Pandemic reduced enrolment and changed clinical protocols
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Out-of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 428 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- Ambulance Victoria, SA Ambulance Service, St John Ambulance Australia (Western Australia), Flinders University, Curtin University
- Responsible party
- Principal investigator, Professor Stephen Bernard, Monash University
- Investigators
- Stephen Bernard, Principal investigator, Ambulance Victoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138005
- Sponsor's protocol ID
- EXACT01
- Other IDs
- APP1107509
- Acronym
- EXACT
- Status last verified
- Sep 2025
- First submitted
- 21 Apr 2017
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
http://www.ambulance.vic.gov.au/Media/docs/VACAR-Annual-Report-201112-39a60ff4-083f-4893-af52-efeef570f6d1-0.pdf
Kaneda T, Ku K, Inoue T, Onoe M, Oku H. Postischemic reperfusion injury can be attenuated by oxygen tension control. Jpn Circ J. 2001 Mar;65(3):213-8. doi: 10.1253/jcj.65.213.
PubMed 11266197Richards EM, Fiskum G, Rosenthal RE, Hopkins I, McKenna MC. Hyperoxic reperfusion after global ischemia decreases hippocampal energy metabolism. Stroke. 2007 May;38(5):1578-84. doi: 10.1161/STROKEAHA.106.473967. Epub 2007 Apr 5.
PubMed 17413048Pilcher J, Weatherall M, Shirtcliffe P, Bellomo R, Young P, Beasley R. The effect of hyperoxia following cardiac arrest - A systematic review and meta-analysis of animal trials. Resuscitation. 2012 Apr;83(4):417-22. doi: 10.1016/j.resuscitation.2011.12.021. Epub 2012 Jan 5.
PubMed 22226734Balan IS, Fiskum G, Hazelton J, Cotto-Cumba C, Rosenthal RE. Oximetry-guided reoxygenation improves neurological outcome after experimental cardiac arrest. Stroke. 2006 Dec;37(12):3008-13. doi: 10.1161/01.STR.0000248455.73785.b1. Epub 2006 Oct 26.
PubMed 17068310Saugstad OD. Resuscitation of newborn infants: from oxygen to room air. Lancet. 2010 Dec 11;376(9757):1970-1. doi: 10.1016/S0140-6736(10)60543-0. Epub 2010 Jul 19. No abstract available.
PubMed 20663546Hellstrom-Westas L, Forsblad K, Sjors G, Saugstad OD, Bjorklund LJ, Marsal K, Kallen K. Earlier Apgar score increase in severely depressed term infants cared for in Swedish level III units with 40% oxygen versus 100% oxygen resuscitation strategies: a population-based register study. Pediatrics. 2006 Dec;118(6):e1798-804. doi: 10.1542/peds.2006-0102.
PubMed 17142501Kilgannon JH, Jones AE, Shapiro NI, Angelos MG, Milcarek B, Hunter K, Parrillo JE, Trzeciak S; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Association between arterial hyperoxia following resuscitation from cardiac arrest and in-hospital mortality. JAMA. 2010 Jun 2;303(21):2165-71. doi: 10.1001/jama.2010.707.
PubMed 20516417Bellomo R, Bailey M, Eastwood GM, Nichol A, Pilcher D, Hart GK, Reade MC, Egi M, Cooper DJ; Study of Oxygen in Critical Care (SOCC) Group. Arterial hyperoxia and in-hospital mortality after resuscitation from cardiac arrest. Crit Care. 2011;15(2):R90. doi: 10.1186/cc10090. Epub 2011 Mar 8.
PubMed 21385416Ihle JF, Bernard S, Bailey MJ, Pilcher DV, Smith K, Scheinkestel CD. Hyperoxia in the intensive care unit and outcome after out-of-hospital ventricular fibrillation cardiac arrest. Crit Care Resusc. 2013 Sep;15(3):186-90.
PubMed 23944204Suzuki S, Eastwood GM, Glassford NJ, Peck L, Young H, Garcia-Alvarez M, Schneider AG, Bellomo R. Conservative oxygen therapy in mechanically ventilated patients: a pilot before-and-after trial. Crit Care Med. 2014 Jun;42(6):1414-22. doi: 10.1097/CCM.0000000000000219.
PubMed 24561566Kuisma M, Boyd J, Voipio V, Alaspaa A, Roine RO, Rosenberg P. Comparison of 30 and the 100% inspired oxygen concentrations during early post-resuscitation period: a randomised controlled pilot study. Resuscitation. 2006 May;69(2):199-206. doi: 10.1016/j.resuscitation.2005.08.010. Epub 2006 Feb 24.
PubMed 16500018Young P, Bailey M, Bellomo R, Bernard S, Dicker B, Freebairn R, Henderson S, Mackle D, McArthur C, McGuinness S, Smith T, Swain A, Weatherall M, Beasley R. HyperOxic Therapy OR NormOxic Therapy after out-of-hospital cardiac arrest (HOT OR NOT): a randomised controlled feasibility trial. Resuscitation. 2014 Dec;85(12):1686-91. doi: 10.1016/j.resuscitation.2014.09.011. Epub 2014 Sep 28.
PubMed 25261605Young P, Pilcher J, Patel M, Cameron L, Braithwaite I, Weatherall M, Beasley R. Delivery of titrated oxygen via a self-inflating resuscitation bag. Resuscitation. 2013 Mar;84(3):391-4. doi: 10.1016/j.resuscitation.2012.08.330. Epub 2012 Sep 3.
PubMed 22955052Bernard SA, Smith K, Cameron P, Masci K, Taylor DM, Cooper DJ, Kelly AM, Silvester W; Rapid Infusion of Cold Hartmanns Investigators. Induction of prehospital therapeutic hypothermia after resuscitation from nonventricular fibrillation cardiac arrest*. Crit Care Med. 2012 Mar;40(3):747-53. doi: 10.1097/CCM.0b013e3182377038.
PubMed 22020244
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Oxygen After Cardiac Arrest (EXACT): The EXACT Study
- ClinicalTrials.gov ID
- NCT03138005
- Acronym / sponsor ID
- EXACT / EXACT01
- Conditions
- Out-of-Hospital Cardiac Arrest
- Keywords
- Emergency Care, Prehospital, Resuscitation, Oxygen, Cardiac Arrest, Heart Arrest
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pandemic reduced enrolment and changed clinical protocols
- Enrolment
- 428 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Collaborators
- Ambulance Victoria, SA Ambulance Service, St John Ambulance Australia (Western Australia), Flinders University, Curtin University
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 5 Aug 2020 (actual)
- Study completion
- 5 Aug 2020 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Reduction of oxygen after cardiac arrest (EXACT) is a multi-centre, randomised, controlled trial (RCT) to determine whether reducing oxygen administration to target an oxygen saturation of 90-94%, compared to 98-100%, as soon as possible following successful resuscitation from OHCA improves outcome at hospital discharge.
Detailed description
Currently out-of-hospital cardiac arrest (OHCA) patients who achieve ROSC are routinely ventilated with the highest fraction of inspired oxygen (FiO2) possible (i.e. FiO2 1.0 or 100% oxygen) until admission to an intensive care unit (ICU) - usually a period of 2 to 6 hours post-ROSC.
Post-ROSC oxygen therapy begins in the field by emergency medical services (EMS). EMS typically deliver a high flow of oxygen at rate of >10L/min (~100% oxygen), and use a pulse oximeter to monitor oxygen levels (SpO2). Normal SpO2 levels are considered to be 94% to 100%. The delivery of 100% oxygen is then usually continued throughout a patient's stay in the emergency department (ED) and during any diagnostic testing (e.g. computed tomography scans and cardiac angiography). During this time, oxygen is delivered to patients who remain unconscious via a mechanical ventilator, with levels continuously monitored by pulse oximetry and periodically by a blood test called an arterial blood gas (ABG). The ABG measurements include the oxygen pressure in the blood (PaO2) in mmHg. Once a patient is admitted to the ICU, the PaO2 is assessed and the oxygen fraction is typically reduced and then titrated (reduced or increased) on the ventilator to achieve a normal level of PaO2 ("normoxia") of between 80-100mmHg.
The administration of 100% oxygen for the first hours after resuscitation is based largely on convention and not on any supportive clinical data. It has been thought that maximizing oxygen delivery for several hours might be beneficial in a patient who has suffered profound deprivation of oxygen supply ("hypoxia") during a cardiac arrest. In addition, if a lower fraction of inspired oxygen is delivered, there is a perceived risk that the patient might become hypoxic (i.e. SpO2 <90% or PaO2 <80mmHg). Until recently, there has been no particular reason to recommend a decrease in oxygen delivery to the post-arrest patient prior to admission to ICU.
However, recent systematic reviews of compelling experimental data and supportive human observational studies indicate that the administration of 100% oxygen can create "hyperoxic" levels in the early post arrest period which may lead to additional neurological injury, and thus result in worse clinical outcome. No randomised control trials have yet tested titrating oxygen administration to lower but normal levels (i.e. "normoxia").
EXACT is a Phase 3 multi-centre, randomised, controlled trial (RCT) aiming to determine whether reducing oxygen administration to target an oxygen saturation of 90-94%, compared to 98-100%, as soon as possible following successful resuscitation from OHCA improves outcome at hospital discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| target SpO2 98-100% | Active comparator | Other: target SpO2 98-100%Post ROSC oxygen titrated to maintain SpO2 between 98-100% |
| target SpO2 90-94% | Experimental | Other: target SpO2 90-94%Post ROSC oxygen titrated to maintain SpO2 between 90-94% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults (age 18 years or older)
- Out-of-hospital cardiac arrest of presumed cardiac cause
- All cardiac arrest rhythms
- Unconscious (Glasgow Coma Scale <9)
- Return of spontaneous circulation
Key exclusion criteria (5 listed)
- Female who is known or suspected to be pregnant
- Dependent on others for activities of daily living (i.e. facilitated care or nursing home residents)
- "Not for Resuscitation" order or Advanced Care Directives in place
- Pre-existing oxygen therapy (i.e. for COPD)
- Cardiac arrest due to drowning, trauma or hanging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| target SpO2 98-100%Prehospital, post-ROSC oxygen maintained at ≥10L/minute of oxygen (equivalent to ~100% oxygen) into SGA/ETT if hand ventilated or 100% (i.e. FiO2 of 1.0) oxygen settings if mechanically ventilated. Patients will continue on treatment to handover in the ED. Between arrival at ED and first ABG in ICU, the oxygen setting may then be decreased provided SpO2 is maintained between 98-100%. | Other | target SpO2 98-100% |
| target SpO2 90-94%Prehospital, post-ROSC oxygen reduced initially to 4L/minute (i.e. approximately 70% oxygen) into SGA/ETT if hand ventilated or an air mix setting if mechanically ventilated. If oxygen saturation remains ≥94% for 5 minutes, the oxygen flow rate will be further reduced to 2L/minute (i.e. approximately 46% oxygen) and hand ventilated to target an oxygen saturation between 90-94%. This treatment will continue to patient handover in the emergency department. Between arrival at ED and first ABG in ICU, oxygen will be titrated to target a oxygen saturation of 90-94%. | Other | target SpO2 90-94% |
Primary outcome
Survival to hospital discharge
Time frame: At hospital discharge, participants will be followed for the duration of hospital stay, an expected average of 2-4 weeks
Survival to hospital discharge
13 secondary outcomes
Neurological outcome
Time frame: At hospital discharge, participants will be followed for the duration of hospital stay, an expected average of 2-4 weeks
Incidence of hypoxia (SpO2<90%)
Time frame: Before ICU admission, an expected average of 4-6 hours
Recurrent cardiac arrest
Time frame: Before ICU admission, an expected average of 4-6 hours
Myocardial Injury
Time frame: First 24 hours of hospital admission
Survival to intensive care unit discharge
Time frame: Intensive care discharge, an expected average of 7 days
Length of ICU stay
Time frame: Intensive care discharge, an expected average of 7 days
Length of hospital stay
Time frame: At hospital discharge, participants will be followed for the duration of hospital stay, an expected average of 2-4 weeks
Cause of death during hospital stay
Time frame: At hospital discharge, participants will be followed for the duration of hospital stay, an expected average of 2-4 weeks
Quality of Life SF-12
Time frame: 12 months
Quality of Life EQ-5D-3L
Time frame: 12 months
Neurological Function
Time frame: 12 months
Degree of recovery (GOS-E)
Time frame: 12 months
Survival at 12 months
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Pandemic reduced enrolment and changed clinical protocols). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Backgroundhttp://www.ambulance.vic.gov.au/Media/docs/VACAR-Annual-Report-201112-39a60ff4-083f-4893-af52-efeef570f6d1-0.pdf
- Background: PubMed 11266197Kaneda T, Ku K, Inoue T, Onoe M, Oku H. Postischemic reperfusion injury can be attenuated by oxygen tension control. Jpn Circ J. 2001 Mar;65(3):213-8. doi: 10.1253/jcj.65.213.
- Background: PubMed 17413048Richards EM, Fiskum G, Rosenthal RE, Hopkins I, McKenna MC. Hyperoxic reperfusion after global ischemia decreases hippocampal energy metabolism. Stroke. 2007 May;38(5):1578-84. doi: 10.1161/STROKEAHA.106.473967. Epub 2007 Apr 5.
- Background: PubMed 22226734Pilcher J, Weatherall M, Shirtcliffe P, Bellomo R, Young P, Beasley R. The effect of hyperoxia following cardiac arrest - A systematic review and meta-analysis of animal trials. Resuscitation. 2012 Apr;83(4):417-22. doi: 10.1016/j.resuscitation.2011.12.021. Epub 2012 Jan 5.
- Background: PubMed 17068310Balan IS, Fiskum G, Hazelton J, Cotto-Cumba C, Rosenthal RE. Oximetry-guided reoxygenation improves neurological outcome after experimental cardiac arrest. Stroke. 2006 Dec;37(12):3008-13. doi: 10.1161/01.STR.0000248455.73785.b1. Epub 2006 Oct 26.
- Background: PubMed 20663546Saugstad OD. Resuscitation of newborn infants: from oxygen to room air. Lancet. 2010 Dec 11;376(9757):1970-1. doi: 10.1016/S0140-6736(10)60543-0. Epub 2010 Jul 19. No abstract available.
- Background: PubMed 17142501Hellstrom-Westas L, Forsblad K, Sjors G, Saugstad OD, Bjorklund LJ, Marsal K, Kallen K. Earlier Apgar score increase in severely depressed term infants cared for in Swedish level III units with 40% oxygen versus 100% oxygen resuscitation strategies: a population-based register study. Pediatrics. 2006 Dec;118(6):e1798-804. doi: 10.1542/peds.2006-0102.
- Background: PubMed 20516417Kilgannon JH, Jones AE, Shapiro NI, Angelos MG, Milcarek B, Hunter K, Parrillo JE, Trzeciak S; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Association between arterial hyperoxia following resuscitation from cardiac arrest and in-hospital mortality. JAMA. 2010 Jun 2;303(21):2165-71. doi: 10.1001/jama.2010.707.
- Background: PubMed 21385416Bellomo R, Bailey M, Eastwood GM, Nichol A, Pilcher D, Hart GK, Reade MC, Egi M, Cooper DJ; Study of Oxygen in Critical Care (SOCC) Group. Arterial hyperoxia and in-hospital mortality after resuscitation from cardiac arrest. Crit Care. 2011;15(2):R90. doi: 10.1186/cc10090. Epub 2011 Mar 8.
- Background: PubMed 23944204Ihle JF, Bernard S, Bailey MJ, Pilcher DV, Smith K, Scheinkestel CD. Hyperoxia in the intensive care unit and outcome after out-of-hospital ventricular fibrillation cardiac arrest. Crit Care Resusc. 2013 Sep;15(3):186-90.
- Background: PubMed 24561566Suzuki S, Eastwood GM, Glassford NJ, Peck L, Young H, Garcia-Alvarez M, Schneider AG, Bellomo R. Conservative oxygen therapy in mechanically ventilated patients: a pilot before-and-after trial. Crit Care Med. 2014 Jun;42(6):1414-22. doi: 10.1097/CCM.0000000000000219.
- Background: PubMed 16500018Kuisma M, Boyd J, Voipio V, Alaspaa A, Roine RO, Rosenberg P. Comparison of 30 and the 100% inspired oxygen concentrations during early post-resuscitation period: a randomised controlled pilot study. Resuscitation. 2006 May;69(2):199-206. doi: 10.1016/j.resuscitation.2005.08.010. Epub 2006 Feb 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Bernard principal investigator
Ambulance Victoria
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing target SpO2 98-100% and target SpO2 90-94% in people with Out-of-Hospital Cardiac Arrest, run by Monash University at 21 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Pandemic reduced enrolment and changed clinical protocols). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival to hospital discharge (time frame: At hospital discharge, participants will be followed for the duration of hospital stay, an expected average of 2-4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03138005, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.