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

This study is not yet open for participant recruitment.
Verified September 2012 by Austin Health
Sponsor:
Information provided by (Responsible Party):
Rinaldo Bellomo, Austin Health
ClinicalTrials.gov Identifier:
NCT01684124
First received: September 7, 2012
Last updated: September 11, 2012
Last verified: September 2012
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: 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:

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

Further study details as provided by Austin Health:

Primary Outcome Measures:
  • Difference in PaO2/FiO2 ratio from baseline to worst value [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    blood lactate will be measured regularly and assessed during standard care and the intervention period


Other Outcome Measures:
  • arrhythmias [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    patients will have continuous ECG monitoring and arrhythmias will be recorded in the two groups


Estimated Enrollment: 100
Study Start Date: October 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01684124

Locations
Australia, Victoria
Austin Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3079
Contact: Rinaldo Bellomo, MD         rinaldo.bellomo@austin.org.au    
Contact: Glenn Eastwood, RN         glenn.eastwood@austin.org.au    
Principal Investigator: Rinaldo Bellomo, MD            
Sponsors and Collaborators
Austin Health
  More Information

No publications provided

Responsible Party: Rinaldo Bellomo, Director of ICU Research, Austin Health
ClinicalTrials.gov Identifier: NCT01684124     History of Changes
Other Study ID Numbers: AICU2012-008
Study First Received: September 7, 2012
Last Updated: September 11, 2012
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Austin Health:
oxygen
critical illness
mechanical ventilation

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013