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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03138005




Registration number
NCT03138005
Ethics application status
Date submitted
21/04/2017
Date registered
3/05/2017

Titles & IDs
Public title
Reduction of Oxygen After Cardiac Arrest
Scientific title
Reduction of Oxygen After Cardiac Arrest (EXACT): The EXACT Study
Secondary ID [1] 0 0
APP1107509
Secondary ID [2] 0 0
EXACT01
Universal Trial Number (UTN)
Trial acronym
EXACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Out-of-Hospital Cardiac Arrest 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - target SpO2 98-100%
Other interventions - target SpO2 90-94%

Active comparator: target SpO2 98-100% - Post ROSC oxygen titrated to maintain SpO2 between 98-100%

Experimental: target SpO2 90-94% - Post ROSC oxygen titrated to maintain SpO2 between 90-94%


Other interventions: 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 interventions: 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%.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Survival to hospital discharge
Timepoint [1] 0 0
At hospital discharge, participants will be followed for the duration of hospital stay, an expected average of 2-4 weeks
Secondary outcome [1] 0 0
Neurological outcome
Timepoint [1] 0 0
At hospital discharge, participants will be followed for the duration of hospital stay, an expected average of 2-4 weeks
Secondary outcome [2] 0 0
Incidence of hypoxia (SpO2<90%)
Timepoint [2] 0 0
Before ICU admission, an expected average of 4-6 hours
Secondary outcome [3] 0 0
Recurrent cardiac arrest
Timepoint [3] 0 0
Before ICU admission, an expected average of 4-6 hours
Secondary outcome [4] 0 0
Myocardial Injury
Timepoint [4] 0 0
First 24 hours of hospital admission
Secondary outcome [5] 0 0
Survival to intensive care unit discharge
Timepoint [5] 0 0
Intensive care discharge, an expected average of 7 days
Secondary outcome [6] 0 0
Length of ICU stay
Timepoint [6] 0 0
Intensive care discharge, an expected average of 7 days
Secondary outcome [7] 0 0
Length of hospital stay
Timepoint [7] 0 0
At hospital discharge, participants will be followed for the duration of hospital stay, an expected average of 2-4 weeks
Secondary outcome [8] 0 0
Cause of death during hospital stay
Timepoint [8] 0 0
At hospital discharge, participants will be followed for the duration of hospital stay, an expected average of 2-4 weeks
Secondary outcome [9] 0 0
Quality of Life SF-12
Timepoint [9] 0 0
12 months
Secondary outcome [10] 0 0
Quality of Life EQ-5D-3L
Timepoint [10] 0 0
12 months
Secondary outcome [11] 0 0
Neurological Function
Timepoint [11] 0 0
12 months
Secondary outcome [12] 0 0
Degree of recovery (GOS-E)
Timepoint [12] 0 0
12 months
Secondary outcome [13] 0 0
Survival at 12 months
Timepoint [13] 0 0
12 months

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2020
Actual
Sample size
Target
1416
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
The Queen Elizabeth Hospital - Adelaide
Recruitment hospital [3] 0 0
SA Ambulance Service - Adelaide
Recruitment hospital [4] 0 0
Lyell McEwin Hospital - Adelaide
Recruitment hospital [5] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [6] 0 0
Western Health: Footscray Hospital - Melbourne
Recruitment hospital [7] 0 0
Western Health: Sunshine Hospital - Melbourne
Recruitment hospital [8] 0 0
The Royal Melbourne Hospital - Melbourne
Recruitment hospital [9] 0 0
St Vincents Hospital - Melbourne
Recruitment hospital [10] 0 0
Northern Health: The Northern Hospital - Melbourne
Recruitment hospital [11] 0 0
Austin Hospital - Melbourne
Recruitment hospital [12] 0 0
Box Hill Hospital - Melbourne
Recruitment hospital [13] 0 0
Ambulance Victoria - Melbourne
Recruitment hospital [14] 0 0
Eastern Health: Maroondah Hospital - Melbourne
Recruitment hospital [15] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [16] 0 0
Peninusla Health: Frankston Hospital - Melbourne
Recruitment hospital [17] 0 0
Barwon Health: Geelong - Melbourne
Recruitment hospital [18] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [19] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment hospital [20] 0 0
Fiona Stanley Hospital - Perth
Recruitment hospital [21] 0 0
St John Ambulance Western Australia - Perth
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
5011 - Adelaide
Recruitment postcode(s) [3] 0 0
5063 - Adelaide
Recruitment postcode(s) [4] 0 0
5112 - Adelaide
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
3011 - Melbourne
Recruitment postcode(s) [7] 0 0
3021 - Melbourne
Recruitment postcode(s) [8] 0 0
3050 - Melbourne
Recruitment postcode(s) [9] 0 0
3065 - Melbourne
Recruitment postcode(s) [10] 0 0
3076 - Melbourne
Recruitment postcode(s) [11] 0 0
3084 - Melbourne
Recruitment postcode(s) [12] 0 0
3128 - Melbourne
Recruitment postcode(s) [13] 0 0
3130 - Melbourne
Recruitment postcode(s) [14] 0 0
3135 - Melbourne
Recruitment postcode(s) [15] 0 0
3168 - Melbourne
Recruitment postcode(s) [16] 0 0
3199 - Melbourne
Recruitment postcode(s) [17] 0 0
3220 - Melbourne
Recruitment postcode(s) [18] 0 0
6000 - Perth
Recruitment postcode(s) [19] 0 0
6009 - Perth
Recruitment postcode(s) [20] 0 0
6150 - Perth
Recruitment postcode(s) [21] 0 0
6984 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Ambulance Victoria
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
SA Ambulance Service
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
St John Ambulance Australia (Western Australia)
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Flinders University
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Curtin University
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Bernard
Address 0 0
Ambulance Victoria
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Natasha Dodge
Address 0 0
Country 0 0
Phone 0 0
+6139930039
Fax 0 0
Email 0 0
SPHPM.EXACT.Study@monash.edu
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03138005