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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01684124
Recruitment Status : Completed
First Posted : September 12, 2012
Last Update Posted : July 11, 2013
Information provided by (Responsible Party):
Rinaldo Bellomo, Austin Health

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).

Condition or disease Intervention/treatment Phase
Critical Illness Other: conservative O2 therapy Other: standard care Phase 1 Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Before-and-after Assessment of Conservative Oxygen Therapy vs. Standard Care in Critically Ill Mechanically Ventilated Patients
Study Start Date : March 2012
Primary Completion Date : March 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Arm Intervention/treatment
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
target lower O2 saturation

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. Lactate [ Time Frame: 10 days ]
    blood lactate will be measured regularly and assessed during standard care and the intervention period

Other Outcome Measures:
  1. arrhythmias [ Time Frame: 10 days ]
    patients will have continuous ECG monitoring and arrhythmias will be recorded in the two groups

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01684124

Australia, Victoria
Austin Hospital
Melbourne, Victoria, Australia, 3079
Sponsors and Collaborators
Austin Health

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Rinaldo Bellomo, Director of ICU Research, Austin Health Identifier: NCT01684124     History of Changes
Other Study ID Numbers: AICU2012-008
First Posted: September 12, 2012    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013

Keywords provided by Rinaldo Bellomo, Austin Health:
critical illness
mechanical ventilation

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes