Heart ArrestPhase 2EXACTNCT02499042
rEduction of oXygen After Cardiac arresT: a Pilot Study
A Phase 2 study testing Oxygen in people with Heart Arrest, run by Monash University at 2 sites in Australia.
Trial summary
This Phase 2 study aims to determine the feasibility of paramedic titration of oxygen delivery in adult patients who have been resuscitated from OHCA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Arrest
- What is being tested?
- Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 2 sitesAustralia
- Study dates
- Jul 2015to Aug 2017
- Phase
- Phase 2
- 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)
- Out-of-hospital cardiac arrest of presumed cardiac cause
- Initial cardiac rhythm ventricular fibrillation/ ventricular tachycardia ("shockable")
- Unconscious (Glasgow Coma Scale <9)
- In cardiac arrest on ambulance arrival
- Sustained return of spontaneous circulation (>2 minutes)
- Pulse oximeter trace with oxygen saturation measured at ≥95% on bag/ reservoir with oxygen set at ≥10L/min
- Patient is spontaneous breathing or ventilated using bag/valve/oxygen reservoir via endotracheal tube or SGA (i.e. laryngeal mask airway)
Who cannot join
- Female who is known or suspected to be pregnant
- Dependant on others for activities of daily living (i.e. facilitated care or nursing home residents)
- "Not for Resuscitation" order
- EMS witnessed arrests
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
SA Ambulance Service
Adelaide, South Australia
Ambulance Victoria
Melbourne, Victoria
About this study
Official title: rEduction of oXygen After Cardiac arresT (EXACT): a Pilot Study
This Phase 2 study aims to determine the feasibility of paramedic titration of oxygen delivery in adult patients who have been resuscitated from OHCA.
Read the detailed description
This Phase 2 study aims to test whether paramedic titration of oxygen is feasible and results in an equivalent number of patients arriving at the ED with a safe oxygen level compared with the current approach of 100% oxygen.
Hypothesis: There is no difference in the proportion of OHCA patients who arrive at the emergency department with oxygen saturation greater than or equal to 90% whether they received an inspired oxygen fraction of 100% achieved by a flow rate of 10 litres per minute compared to a titrated oxygen fraction achieved by a flow rate of 2 litres per minute.
This is a Phase 2, multi-centre, prospective, randomised study to be conducted in Melbourne and Adelaide.
During cardiac arrest, the patient will receive the current standard of care with oxygen delivery (≥10L/min) by ETT/ SGA connected to bag/valve/ oxygen reservoir.
If ROSC is achieved, all the standard post resuscitation treatments will be given as per current ambulance Clinical Practice Guidelines, except for the amount of oxygen delivered.
The initial ventilation post ROSC for two minutes will be 600mL x 10L/ minute with oxygen flow rate ≥10L/min until a satisfactory pulse oximeter trace and reading is achieved.
After the eligibility criteria are met, the patients will be randomised by the opening of an opaque envelope containing a computer generated allocation to either continued oxygen >10L/min or decreased ("titrated") oxygen 2L/min with a target oxygen saturation of 90-94%.
Patients allocated to oxygen >10L minute ("standard care") will continue on this therapy to hospital.
In the 2L/min oxygen group, the oxygen flow will be changed immediately back to >10L/min if:
- The oxygen saturation falls to <90% at any time, or
- Recurrent cardiac arrest occurs, or
- The pulse oximeter trace fails Following any of these events, this high-flow oxygen will continue to hospital. If a patient is extubated or has a SGA removed post randomisation because of improving conscious state, then standard care will be used (i.e. face mask with oxygen ≥10L/min).
For patients with ROSC in whom intubation is planned, ventilation with high-flow oxygen will continue during the intubation process and randomisation will be delayed until 2 minutes after the ETT is confirmed as correctly placed using ETCO2 and the pulse oximeter trace reads ≥95%.
At ED handover, the patient will receive oxygen therapy as determined by the treating emergency medicine physician.
- Conditions
- Heart Arrest
- Being tested
- Oxygen
- Keywords
- post-resuscitation, oxygen therapy, out-of-hospital cardiac arrest
- Medical subject headings
- Heart Arrest, Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenDrug
oxygen delivery by ETT/ SGA connected to bag/valve/oxygen reservoir
| Study group | Role | What they receive |
|---|---|---|
| Oxygen reduction | Experimental | post-ROSC oxygen reduced to 2L per minute then delivered to maintain oxygen saturation 90-94% to hospital Receives: Drug: Oxygen |
| Standard Care | Active comparator | post-ROSC oxygen maintained ≥10L per minute to hospital Receives: Drug: Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygen saturation ≥90%
Oxygen saturation measured on arrival at hospital by paramedics
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- Ambulance Victoria, SA Ambulance Service, Curtin University, Flinders University
- Responsible party
- Principal investigator, Professor Stephen Bernard, Monash University
- Investigators
- Stephen Bernard, MD, Principal investigator, Monash University / Alfred Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02499042
- Sponsor's protocol ID
- CF14/2953-2014001634
- Acronym
- EXACT
- Status last verified
- Aug 2017
- First submitted
- 8 Jul 2015
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Bray JE, Hein C, Smith K, Stephenson M, Grantham H, Finn J, Stub D, Cameron P, Bernard S; EXACT Investigators. Oxygen titration after resuscitation from out-of-hospital cardiac arrest: A multi-centre, randomised controlled pilot study (the EXACT pilot trial). Resuscitation. 2018 Jul;128:211-215. doi: 10.1016/j.resuscitation.2018.04.019. Epub 2018 Apr 21.
PubMed 29684433
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- rEduction of oXygen After Cardiac arresT (EXACT): a Pilot Study
- ClinicalTrials.gov ID
- NCT02499042
- Acronym / sponsor ID
- EXACT / CF14/2953-2014001634
- Conditions
- Heart Arrest
- Keywords
- post-resuscitation, oxygen therapy, out-of-hospital cardiac arrest
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Collaborators
- Ambulance Victoria, SA Ambulance Service, Curtin University, Flinders University
- Study start
- Jul 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 15 Jul 2015 (estimated)
- 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.
This Phase 2 study aims to determine the feasibility of paramedic titration of oxygen delivery in adult patients who have been resuscitated from OHCA.
Detailed description
This Phase 2 study aims to test whether paramedic titration of oxygen is feasible and results in an equivalent number of patients arriving at the ED with a safe oxygen level compared with the current approach of 100% oxygen.
Hypothesis: There is no difference in the proportion of OHCA patients who arrive at the emergency department with oxygen saturation greater than or equal to 90% whether they received an inspired oxygen fraction of 100% achieved by a flow rate of 10 litres per minute compared to a titrated oxygen fraction achieved by a flow rate of 2 litres per minute.
This is a Phase 2, multi-centre, prospective, randomised study to be conducted in Melbourne and Adelaide.
During cardiac arrest, the patient will receive the current standard of care with oxygen delivery (≥10L/min) by ETT/ SGA connected to bag/valve/ oxygen reservoir.
If ROSC is achieved, all the standard post resuscitation treatments will be given as per current ambulance Clinical Practice Guidelines, except for the amount of oxygen delivered.
The initial ventilation post ROSC for two minutes will be 600mL x 10L/ minute with oxygen flow rate ≥10L/min until a satisfactory pulse oximeter trace and reading is achieved.
After the eligibility criteria are met, the patients will be randomised by the opening of an opaque envelope containing a computer generated allocation to either continued oxygen >10L/min or decreased ("titrated") oxygen 2L/min with a target oxygen saturation of 90-94%.
Patients allocated to oxygen >10L minute ("standard care") will continue on this therapy to hospital.
In the 2L/min oxygen group, the oxygen flow will be changed immediately back to >10L/min if:
- The oxygen saturation falls to <90% at any time, or
- Recurrent cardiac arrest occurs, or
- The pulse oximeter trace fails Following any of these events, this high-flow oxygen will continue to hospital. If a patient is extubated or has a SGA removed post randomisation because of improving conscious state, then standard care will be used (i.e. face mask with oxygen ≥10L/min).
For patients with ROSC in whom intubation is planned, ventilation with high-flow oxygen will continue during the intubation process and randomisation will be delayed until 2 minutes after the ETT is confirmed as correctly placed using ETCO2 and the pulse oximeter trace reads ≥95%.
At ED handover, the patient will receive oxygen therapy as determined by the treating emergency medicine physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygen reduction | Experimental | Drug: Oxygenpost-ROSC oxygen reduced to 2L per minute then delivered to maintain oxygen saturation 90-94% to hospital |
| Standard Care | Active comparator | Drug: Oxygenpost-ROSC oxygen maintained ≥10L per minute to hospital |
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)
- Out-of-hospital cardiac arrest of presumed cardiac cause
- Initial cardiac rhythm ventricular fibrillation/ ventricular tachycardia ("shockable")
- Unconscious (Glasgow Coma Scale <9)
- In cardiac arrest on ambulance arrival
Key exclusion criteria (4 listed)
- Female who is known or suspected to be pregnant
- Dependant on others for activities of daily living (i.e. facilitated care or nursing home residents)
- "Not for Resuscitation" order
- EMS witnessed arrests
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 |
|---|---|---|
| Oxygenoxygen delivery by ETT/ SGA connected to bag/valve/oxygen reservoir | Drug | Oxygen reduction, Standard Care |
Primary outcome
oxygen saturation ≥90%
Time frame: baseline
Oxygen saturation measured on arrival at hospital by paramedics
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
- Derived from this study: PubMed 29684433Bray JE, Hein C, Smith K, Stephenson M, Grantham H, Finn J, Stub D, Cameron P, Bernard S; EXACT Investigators. Oxygen titration after resuscitation from out-of-hospital cardiac arrest: A multi-centre, randomised controlled pilot study (the EXACT pilot trial). Resuscitation. 2018 Jul;128:211-215. doi: 10.1016/j.resuscitation.2018.04.019. Epub 2018 Apr 21.
- The Australian Resuscitation Outcomes Consortium (Aus-ROC)Link provided by the sponsor.
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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, MD principal investigator
Monash University / Alfred Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxygen in people with Heart Arrest, run by Monash University at 2 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 4 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: finished, as of the sponsor's last update on 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
oxygen saturation ≥90% (time frame: baseline). 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 NCT02499042, which also lists 1 linked publication.
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 7 Sep 2017.