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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01684124




Registration number
NCT01684124
Ethics application status
Date submitted
7/09/2012
Date registered
12/09/2012
Date last updated
11/07/2013

Titles & IDs
Public title
An Assessment of the Feasibility and Safety of Conservative Oxygen Therapy in Critically Ill Patients
Scientific title
A Before-and-after Assessment of Conservative Oxygen Therapy vs. Standard Care in Critically Ill Mechanically Ventilated Patients
Secondary ID [1] 0 0
AICU2012-008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - conservative O2 therapy
Other interventions - standard care

Placebo Comparator: standard care - normal treatment

Active Comparator: conservative O2 therapy - a value of 90-92% O2 saturation will be targeted


Other interventions: conservative O2 therapy
target lower O2 saturation

Other interventions: standard care
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Difference in PaO2/FiO2 ratio from baseline to worst value
Timepoint [1] 0 0
10 days
Secondary outcome [1] 0 0
Lactate
Timepoint [1] 0 0
10 days

Eligibility
Key inclusion criteria
- Mechanical ventilation

- expected to be ventilated until the day after tomorrow (a tiem frame of, on average 48
hours)
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- expected to be off mechanical ventilation today or tomorrow

- carbon monoxide poisoning

- necrotizing fasciitis

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2013
Sample size
Target
Accrual to date
Final
105
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3079 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Austin Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The investigators hypothesize that it is feasible and safe to deliver a conservative approach
to oxygen therapy in mechanically ventilated critically ill patients (a tiem frame of, on
average,10 days).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01684124
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01684124