NCT01684124

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

July 11, 2013

Status Verified

July 1, 2013

Enrollment Period

1 year

First QC Date

September 7, 2012

Last Update Submit

July 9, 2013

Conditions

Critical Illness

Keywords

oxygencritical illnessmechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Lactate

    10 days

Other Outcomes (1)

  • arrhythmias

    10 days

Study Arms (2)

standard care

PLACEBO COMPARATOR

normal treatment

Other: standard care

conservative O2 therapy

ACTIVE COMPARATOR

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

Other: conservative O2 therapy

Interventions

conservative O2 therapyOTHER

target lower O2 saturation

conservative O2 therapy
standard careOTHER
standard care

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mechanical ventilation
  • expected to be ventilated until the day after tomorrow (a tiem frame of, on average 48 hours)

You may not qualify if:

  • expected to be off mechanical ventilation today or tomorrow
  • carbon monoxide poisoning
  • necrotizing fasciitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Austin Hospital

Melbourne, Victoria, 3079, Australia

Location

Related Publications (1)

  • 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.

    PMID: 26718090DERIVED

MeSH Terms

Conditions

Critical Illness

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of ICU Research

Study Record Dates

First Submitted

September 7, 2012

First Posted

September 12, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

July 11, 2013

Record last verified: 2013-07

Locations

AU(1)