Back to resultsAn Assessment of the Feasibility and Safety of Conservative Oxygen Therapy in Critically Ill Patients
Primary Purpose
Critical Illness
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
conservative O2 therapy
standard care
Sponsored by
About this trial
This is an interventional treatment trial for Critical Illness focused on measuring oxygen, critical illness, mechanical ventilation
Eligibility 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
Sites / Locations
- Austin Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
standard care
conservative O2 therapy
Arm Description
normal treatment
a value of 90-92% O2 saturation will be targeted
Outcomes
Primary Outcome Measures
Difference in PaO2/FiO2 ratio from baseline to worst value
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
blood lactate will be measured regularly and assessed during standard care and the intervention period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01684124
Brief Title
An Assessment of the Feasibility and Safety of Conservative Oxygen Therapy in Critically Ill Patients
Official Title
A Before-and-after Assessment of Conservative Oxygen Therapy vs. Standard Care in Critically Ill Mechanically Ventilated Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Austin Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
Detailed Description
Identify patients likely to require ventilation until the day after tomorrow (a time frame of 36 hours of average)
Deliver a conservative oxygen therapy protocol while in ICU (a time frame on average of 10 days)
Target an oxygen saturation between 90 and 92%
Adjust FiO2 to achieve target SaO2 at all times
Assess percentage of time patient is within target
Assess for safety of this approach
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
oxygen, critical illness, mechanical ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
standard care
Arm Type
Placebo Comparator
Arm Description
normal treatment
Arm Title
conservative O2 therapy
Arm Type
Active Comparator
Arm Description
a value of 90-92% O2 saturation will be targeted
Intervention Type
Other
Intervention Name(s)
conservative O2 therapy
Intervention Description
target lower O2 saturation
Intervention Type
Other
Intervention Name(s)
standard care
Primary Outcome Measure Information:
Title
Difference in PaO2/FiO2 ratio from baseline to worst value
Description
Pao2/FiO2 ratio will be measured regularly and compared during standard care and the intervention period (a time frame of, on average, 10 days)
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Lactate
Description
blood lactate will be measured regularly and assessed during standard care and the intervention period
Time Frame
10 days
Other Pre-specified Outcome Measures:
Title
arrhythmias
Description
patients will have continuous ECG monitoring and arrhythmias will be recorded in the two groups
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Austin Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3079
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
26718090
Citation
Eastwood GM, Tanaka A, Espinoza ED, Peck L, Young H, Martensson J, Zhang L, Glassford NJ, Hsiao YF, Suzuki S, Bellomo R. Conservative oxygen therapy in mechanically ventilated patients following cardiac arrest: A retrospective nested cohort study. Resuscitation. 2016 Apr;101:108-14. doi: 10.1016/j.resuscitation.2015.11.026. Epub 2015 Dec 21.
Results Reference
derived
Learn more about this trial
An Assessment of the Feasibility and Safety of Conservative Oxygen Therapy in Critically Ill Patients
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