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

NCT ID: NCT01684124

Last Updated: 2013-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-03-31

Brief Summary

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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

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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

Conditions

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Critical Illness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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standard care

normal treatment

Group Type PLACEBO_COMPARATOR

standard care

Intervention Type OTHER

conservative O2 therapy

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

Group Type ACTIVE_COMPARATOR

conservative O2 therapy

Intervention Type OTHER

target lower O2 saturation

Interventions

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conservative O2 therapy

target lower O2 saturation

Intervention Type OTHER

standard care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Austin Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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Rinaldo Bellomo

Director of ICU Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Austin Hospital

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type DERIVED
PMID: 26718090 (View on PubMed)

Other Identifiers

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AICU2012-008

Identifier Type: -

Identifier Source: org_study_id

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