Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01684124
Recruitment Status : Completed
First Posted : September 12, 2012
Last Update Posted : July 11, 2013
Sponsor:
Information provided by (Responsible Party):
Rinaldo Bellomo, 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).

Condition or disease Intervention/treatment Phase
Critical Illness Other: conservative O2 therapy Other: standard care Phase 1 Phase 2

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Before-and-after Assessment of Conservative Oxygen Therapy vs. Standard Care in Critically Ill Mechanically Ventilated Patients
Study Start Date : March 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Placebo Comparator: standard care
normal treatment
Other: standard care
Active Comparator: conservative O2 therapy
a value of 90-92% O2 saturation will be targeted
Other: conservative O2 therapy
target lower O2 saturation




Primary Outcome Measures :
  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 Outcome Measures :
  1. Lactate [ Time Frame: 10 days ]
    blood lactate will be measured regularly and assessed during standard care and the intervention period


Other Outcome Measures:
  1. arrhythmias [ Time Frame: 10 days ]
    patients will have continuous ECG monitoring and arrhythmias will be recorded in the two groups



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684124


Locations
Layout table for location information
Australia, Victoria
Austin Hospital
Melbourne, Victoria, Australia, 3079
Sponsors and Collaborators
Austin Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Rinaldo Bellomo, Director of ICU Research, Austin Health
ClinicalTrials.gov Identifier: NCT01684124    
Other Study ID Numbers: AICU2012-008
First Posted: September 12, 2012    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013
Keywords provided by Rinaldo Bellomo, Austin Health:
oxygen
critical illness
mechanical ventilation
Additional relevant MeSH terms:
Layout table for MeSH terms
Critical Illness
Disease Attributes
Pathologic Processes