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OpenTrials
Completed

NCT Number: NCT01684124

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

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).

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Austin Hospital

Melbourne, Victoria, 3079, Australia

About this study

  • Identify patients likely to require ventilation until the day after tomorrow (a time frame of 36 hours of average)
  • Deliver a conservative oxygen therapy protocol while in ICU (a time frame on average of 10 days)
  • Target an oxygen saturation between 90 and 92%
  • Adjust FiO2 to achieve target SaO2 at all times
  • Assess percentage of time patient is within target
  • Assess for safety of this approach

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

conservative O2 therapy

Other

target lower O2 saturation

Standard care

Other

Primary outcomes

  1. Difference in PaO2/FiO2 ratio from baseline to worst value

    Time frame: 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 outcomes

  1. Lactate

    Time frame: 10 days

    blood lactate will be measured regularly and assessed during standard care and the intervention period

Other outcomes

  1. arrhythmias

    Time frame: 10 days

    patients will have continuous ECG monitoring and arrhythmias will be recorded in the two groups

Sponsors and collaborators

Lead sponsor

Austin Health

Other Gov

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 12, 2012
Registry last updated
Jul 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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