Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000066886
Ethics application status
Not yet submitted
Date submitted
4/01/2012
Date registered
12/01/2012
Date last updated
12/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Continuous Measurement of Oxygen Consumption from the Airway in intubated Patients attached to a Ventilator Circuit - An Observational Study
Scientific title
Continuous Measurement of Oxygen Consumption from the Airway in Intubated Patients attached to a Ventilator Circuit - An Observational Study
Secondary ID [1] 279691 0
Nil Known
Universal Trial Number (UTN)
U1111-1125-8113
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
We seek to produce a simple, easy-to-use, cost-effective oxygen consumption measurement device. 279163 0
Condition category
Condition code
Cardiovascular 279350 279350 0 0
Normal development and function of the cardiovascular system
Respiratory 285560 285560 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Inspired and expired oxygen fraction are sampled sequentially using a common electrode. Mixed expired pCO2 is measured. Oxygen is precision added to the mixed expired gas until, allowing for water vapour and CO2, the mixed expired pO2 equals the inspired pO2. The rate of oxygen addition then equals the oxygen consumption.
The duration of observation will be about 6 hours.
Intervention code [1] 283716 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286118 0
Continuous measurement of oxygen consumption.
The rate of 02 consumption is equal to the rate of 02 addition when the corrected expired p02 is equal to the inspired p02.
Timepoint [1] 286118 0
Whilst the patient is intubated and attached to a ventilator circuit for up to 24 hours.
Secondary outcome [1] 295182 0
nil
Timepoint [1] 295182 0
n/a

Eligibility
Key inclusion criteria
Intubated Patients attached to a ventilator circuit.
Pregnant women included
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients not requiring to be intubated.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284354 0
Hospital
Name [1] 284354 0
Monash Medical Centre
Country [1] 284354 0
Australia
Primary sponsor type
Hospital
Name
Monash Medical Centre
Address
Monash Medical Centre
246 Clayton Road
Clayton, Victoria, 3168
Country
Australia
Secondary sponsor category [1] 283292 0
None
Name [1] 283292 0
Address [1] 283292 0
Country [1] 283292 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286315 0
Ethics committee address [1] 286315 0
Ethics committee country [1] 286315 0
Date submitted for ethics approval [1] 286315 0
19/09/2011
Approval date [1] 286315 0
Ethics approval number [1] 286315 0
11310A

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33387 0
Address 33387 0
Country 33387 0
Phone 33387 0
Fax 33387 0
Email 33387 0
Contact person for public queries
Name 16634 0
A/Prof Geoffrey Parkin
Address 16634 0
Intensive Care Unit
Monash Medical Centre
246 Clayton Road
Clayton, Victoria 3168
Country 16634 0
Australia
Phone 16634 0
+61 3 9594 3277
Fax 16634 0
+61 3 9594 6297
Email 16634 0
[email protected]
Contact person for scientific queries
Name 7562 0
A/Prof Geoffrey Parkin
Address 7562 0
Intensive Care Unit
Monash Medical Centre
246 Clayton Road
Clayton, Victoria 3168
Country 7562 0
Australia
Phone 7562 0
+61 3 9594 3277
Fax 7562 0
+61 3 9594 6297
Email 7562 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.