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

This study has been completed.
Information provided by (Responsible Party):
Rinaldo Bellomo, Austin Health Identifier:
First received: September 7, 2012
Last updated: July 9, 2013
Last verified: July 2013
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 Intervention Phase
Critical Illness Other: conservative O2 therapy Other: standard care Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Rinaldo Bellomo, Austin Health:

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

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

Enrollment: 105
Study Start Date: March 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01684124

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

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
Study First Received: September 7, 2012
Last Updated: July 9, 2013

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

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes processed this record on September 19, 2017