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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rinaldo Bellomo, Austin Health
ClinicalTrials.gov Identifier:
NCT01684124
First received: September 7, 2012
Last updated: July 9, 2013
Last verified: July 2013
  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:


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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684124

Locations
Australia, Victoria
Austin Hospital
Melbourne, Victoria, Australia, 3079
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: July 9, 2013
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 July 22, 2014