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

Phase 1

Completed

• Conditions: Critical Illness
• Interventions: Other: conservative O2 therapy; Other: standard care

• Registration Number: NCT01684124
• Lead Sponsor: Austin Health

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

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-09-07
• Study First Submitted QC: 2012-09-11
• Study First Posted: 2012-09-12
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-09
• Last Update Posted: 2013-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
conservative O2 therapy	conservative O2 therapy	a value of 90-92% O2 saturation will be targeted
standard care	standard care	normal treatment

Primary Outcome Measures

Name	Time	Method
Difference in PaO2/FiO2 ratio from baseline to worst value	10 days	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

Name	Time	Method
Lactate	10 days	blood lactate will be measured regularly and assessed during standard care and the intervention period

Trial Locations

Locations (1)

Austin Hospital; 🇦🇺 Melbourne, Victoria, Australia