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

Austin Health

Status and phase: Completed; Phase 2; Phase 1

Conditions: Critical Illness

Treatments: Other: conservative O2 therapy; Other: standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT01684124

AICU2012-008

Details and patient eligibility

About

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).

Full 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

Enrollment: 105 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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105 participants in 2 patient groups, including a placebo group

standard care

Placebo Comparator group

Description:

normal treatment

Treatment:

Other: standard care

conservative O2 therapy

Active Comparator group

Description:

a value of 90-92% O2 saturation will be targeted

Treatment:

Other: conservative O2 therapy