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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01684124
First Posted: September 12, 2012
Last Update Posted: July 11, 2013
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.
Information provided by (Responsible Party):
Rinaldo Bellomo, Austin Health
  Purpose
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
  Eligibility

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
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT01684124


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rinaldo Bellomo, Director of ICU Research, Austin Health
ClinicalTrials.gov Identifier: NCT01684124     History of Changes
Other Study ID Numbers: AICU2012-008
First Submitted: September 7, 2012
First Posted: September 12, 2012
Last Update Posted: July 11, 2013
Last Verified: July 2013

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

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes