Critical IllnessPhase 1/2NCT01684124
An Assessment of the Feasibility and Safety of Conservative Oxygen Therapy in Critically Ill Patients
A Phase 1/2 study testing conservative O2 therapy in people with Critical Illness, run by Austin Health at 1 site in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- conservative O2 therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2012to Mar 2013
- Phase
- Phase 1/2
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mechanical ventilation
- expected to be ventilated until the day after tomorrow (a tiem frame of, on average 48 hours)
Who cannot join
- expected to be off mechanical ventilation today or tomorrow
- carbon monoxide poisoning
- necrotizing fasciitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Before-and-after Assessment of Conservative Oxygen Therapy vs. Standard Care in Critically Ill Mechanically Ventilated Patients
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).
Read the detailed description
- Identify patients likely to require ventilation until the day after tomorrow (a time frame of 36 hours of average)
- Deliver a conservative oxygen therapy protocol while in ICU (a time frame on average of 10 days)
- Target an oxygen saturation between 90 and 92%
- Adjust FiO2 to achieve target SaO2 at all times
- Assess percentage of time patient is within target
- Assess for safety of this approach
- Conditions
- Critical Illness
- Being tested
- conservative O2 therapy, standard care
- Keywords
- oxygen, critical illness, mechanical ventilation
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conservative O2 therapyOther
target lower O2 saturation
standard careOther
| Study group | Role | What they receive |
|---|---|---|
| standard care | Placebo comparator | normal treatment Receives: Other: standard care |
| conservative O2 therapy | Active comparator | a value of 90-92% O2 saturation will be targeted Receives: Other: conservative O2 therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in PaO2/FiO2 ratio from baseline to worst value
Pao2/FiO2 ratio will be measured regularly and compared during standard care and the intervention period (a time frame of, on average, 10 days)
Measured: 10 days
Secondary outcomes (1)
Lactate
blood lactate will be measured regularly and assessed during standard care and the intervention period
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2013
- Study completionMar 2013
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 Critical IllnessStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Austin Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rinaldo Bellomo, Austin Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684124
- Sponsor's protocol ID
- AICU2012-008
- Status last verified
- Jul 2013
- First submitted
- 7 Sep 2012
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Eastwood GM, Tanaka A, Espinoza ED, Peck L, Young H, Martensson J, Zhang L, Glassford NJ, Hsiao YF, Suzuki S, Bellomo R. Conservative oxygen therapy in mechanically ventilated patients following cardiac arrest: A retrospective nested cohort study. Resuscitation. 2016 Apr;101:108-14. doi: 10.1016/j.resuscitation.2015.11.026. Epub 2015 Dec 21.
PubMed 26718090
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Before-and-after Assessment of Conservative Oxygen Therapy vs. Standard Care in Critically Ill Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT01684124
- Acronym / sponsor ID
- AICU2012-008
- Conditions
- Critical Illness
- Keywords
- oxygen, critical illness, mechanical ventilation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Austin HealthOther government
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 12 Sep 2012 (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.
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).
Detailed description
- Identify patients likely to require ventilation until the day after tomorrow (a time frame of 36 hours of average)
- Deliver a conservative oxygen therapy protocol while in ICU (a time frame on average of 10 days)
- Target an oxygen saturation between 90 and 92%
- Adjust FiO2 to achieve target SaO2 at all times
- Assess percentage of time patient is within target
- Assess for safety of this approach
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard care | Placebo comparator | Other: standard carenormal treatment |
| conservative O2 therapy | Active comparator | Other: conservative O2 therapya value of 90-92% O2 saturation will be targeted |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mechanical ventilation
- expected to be ventilated until the day after tomorrow (a tiem frame of, on average 48 hours)
Key exclusion criteria (3 listed)
- expected to be off mechanical ventilation today or tomorrow
- carbon monoxide poisoning
- necrotizing fasciitis
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 |
|---|---|---|
| conservative O2 therapytarget lower O2 saturation | Other | conservative O2 therapy |
| standard care | Other | standard care |
Primary outcome
Difference in PaO2/FiO2 ratio from baseline to worst value
Time frame: 10 days
Pao2/FiO2 ratio will be measured regularly and compared during standard care and the intervention period (a time frame of, on average, 10 days)
1 secondary outcome
Lactate
Time frame: 10 days
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 11 Jul 2013.
- Derived from this study: PubMed 26718090Eastwood GM, Tanaka A, Espinoza ED, Peck L, Young H, Martensson J, Zhang L, Glassford NJ, Hsiao YF, Suzuki S, Bellomo R. Conservative oxygen therapy in mechanically ventilated patients following cardiac arrest: A retrospective nested cohort study. Resuscitation. 2016 Apr;101:108-14. doi: 10.1016/j.resuscitation.2015.11.026. Epub 2015 Dec 21.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing conservative O2 therapy in people with Critical Illness, run by Austin Health at 1 site 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 2 inclusion and 3 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 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Difference in PaO2/FiO2 ratio from baseline to worst value (time frame: 10 days). 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 NCT01684124, 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 11 Jul 2013.