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CompletedNCT01684124Updated Jul 11, 2013

An Assessment of the Feasibility and Safety of Conservative Oxygen Therapy in Critically Ill Patients

A Phase 1/2 interventional study of conservative O2 therapy and standard care in Critical Illness, sponsored by Austin Health. Completed at 1 site in Australia. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2013-07-11.

Sponsored by Austin Health · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
105
Allocation
Non-randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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 the detailed description
  1. Identify patients likely to require ventilation until the day after tomorrow (a time frame of 36 hours of average)
  2. Deliver a conservative oxygen therapy protocol while in ICU (a time frame on average of 10 days)
  3. Target an oxygen saturation between 90 and 92%
  4. Adjust FiO2 to achieve target SaO2 at all times
  5. Assess percentage of time patient is within target
  6. Assess for safety of this approach
02

Conditions studied

  • Critical Illness

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Keywords

  • oxygen
  • critical illness
  • mechanical ventilation
03

In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.

This study's enrollment of 105 is above the median of 90 across 979 interventional studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Austin Health is the lead sponsor of 41 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Mechanical ventilation
  • expected to be ventilated until the day after tomorrow (a tiem frame of, on average 48 hours)

Exclusion criteria

Exclusion Criteria:

  • expected to be off mechanical ventilation today or tomorrow
  • carbon monoxide poisoning
  • necrotizing fasciitis
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
105 participants (actual)

Study arms

  • Placebo comparator
    standard care

    normal treatment

    Other: standard care

  • Active comparator
    conservative O2 therapy

    a value of 90-92% O2 saturation will be targeted

    Other: conservative O2 therapy

Interventions

  • Otherconservative O2 therapy

    target lower O2 saturation

  • Otherstandard care
06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 10 days

Secondary outcomes

  1. Lactate

    blood lactate will be measured regularly and assessed during standard care and the intervention period

    Time frame: 10 days

Other outcomes

  1. arrhythmias

    patients will have continuous ECG monitoring and arrhythmias will be recorded in the two groups

    Time frame: 10 days

07

Study locations

1 site
  • Austin Hospital
    Melbourne, Victoria 3079, Australia
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01684124
Lead sponsor
Austin Health
Responsible party
Rinaldo Bellomo (Director of ICU Research, Austin Health) — Principal investigator
First posted
Sep 12, 2012
Start date
Mar 2012
Primary completion
Mar 2013
Completion
Mar 2013
Last update
Jul 11, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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