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

A Before-and-after Assessment of Conservative Oxygen Therapy vs. Standard Care in Critically Ill Mechanically Ventilated Patients

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01684124
Enrollment
105
Registered
2012-09-12
Start date
2012-03-31
Completion date
2013-03-31
Last updated
2013-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

Keywords

oxygen, critical illness, mechanical ventilation

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

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

Interventions

OTHERstandard care
OTHERconservative O2 therapy

target lower O2 saturation

Sponsors

Austin Health
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Difference in PaO2/FiO2 ratio from baseline to worst value10 daysPao2/FiO2 ratio will be measured regularly and compared during standard care and the intervention period (a time frame of, on average, 10 days)

Secondary

MeasureTime frameDescription
Lactate10 daysblood lactate will be measured regularly and assessed during standard care and the intervention period

Other

MeasureTime frameDescription
arrhythmias10 dayspatients will have continuous ECG monitoring and arrhythmias will be recorded in the two groups

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026