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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01684124
• Other study ID #: AICU2012-008
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 7, 2012
• Last updated: July 9, 2013
• Start date: March 2012
• Est. completion date: March 2013

Study information

• Verified date: July 2013
• Source: Austin Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness

Intervention

Other:
• conservative O2 therapy
target lower O2 saturation
• standard care

Locations

Country	Name	City	State
Australia	Austin Hospital	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Austin Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	arrhythmias	patients will have continuous ECG monitoring and arrhythmias will be recorded in the two groups	10 days	No
Primary	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)	10 days	Yes
Secondary	Lactate	blood lactate will be measured regularly and assessed during standard care and the intervention period	10 days	Yes