Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000707965
Ethics application status
Approved
Date submitted
5/05/2011
Date registered
8/07/2011
Date last updated
10/10/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of minimally invasive cardiac output monitors in the detection of hypovolaemia in awake volunteers.
Scientific title
Awake volunteer study of controlled hypovolaemia investigating the ability of minimially invasive cardiac output monitors (LiDCO Rapid, FloTRAC, Oesophageal doppler and USCOM) in detecting known blood loss.
Secondary ID [1] 262120 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypovolaemia 265797 0
Condition category
Condition code
Anaesthesiology 265951 265951 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be monitored with an arterial line (connected to LiDCO rapid and FloTrac monitors), oesophageal doppler and suprasternal doppler.
Participants will be venesected incrementally to a 20% blood loss.
The venesection will be a once only event lasting over approximately 2 hours..
FloTrac and LiDCO are arterial pulse wave contour analysis devices that derive information about the cardiovascular system from the nature of the observered arterial waveform.
Oesophageal doppler uses ultrasound to assess blood flow in the descending aorta and interperets this flow based on the patients age and body habitus.
Suprasternal doppler (USCOM) also uses doppler to assess flow but from the suprasternal notch rather than from the oesophagus.
Intervention code [1] 264535 0
Treatment: Devices
Comparator / control treatment
All participants will be monitored with all the monitors of cardiovascular status being studied, effectively acting as their own control.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266703 0
Ability of monitor (LiDCO rapid, FloTRAC, Oesophageal doppler and USCOM) to detect a known 10% blood loss.
Timepoint [1] 266703 0
At time of 10% blood loss
Secondary outcome [1] 276221 0
Ability of above monitors to detect incremental blood loss.
Timepoint [1] 276221 0
5 minutely assessment of fluid status and monitor output up to 2 hours.
Secondary outcome [2] 279048 0
Isofuran and isoprostane levels
Timepoint [2] 279048 0
assessed at each incremental level of venesection

Eligibility
Key inclusion criteria
Healthy adult, not taking cardiovascularly active medication
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Cardiovascular medications
abnormal cardiovascular history or examination

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consenting anaesthetists able to give informed consent will be recruited to the trial.
All participants will be incrementally venesected and have all 4 monitors of cardiac output used
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3996 0
6160

Funding & Sponsors
Funding source category [1] 265022 0
Hospital
Name [1] 265022 0
Fremantle Hospital
Country [1] 265022 0
Australia
Primary sponsor type
Hospital
Name
Fremantle Hospital
Address
Alma St,
Fremantle, WA 6160
Country
Australia
Secondary sponsor category [1] 264117 0
None
Name [1] 264117 0
Address [1] 264117 0
Country [1] 264117 0
Australia
Other collaborator category [1] 252097 0
Individual
Name [1] 252097 0
Tomas Corcoran
Address [1] 252097 0
Department of Anaesthesia
Royal Perth Hospital
Perth WA 6000
Country [1] 252097 0
Australia
Other collaborator category [2] 252098 0
Individual
Name [2] 252098 0
Trevor Mori
Address [2] 252098 0
University of Western Australia
Nedlands WA 6009
Country [2] 252098 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267003 0
South Metropolitan Area Health Service Human Research Ethics Committee
Ethics committee address [1] 267003 0
Alma St,
Fremantle, WA 6160
Ethics committee country [1] 267003 0
Australia
Date submitted for ethics approval [1] 267003 0
Approval date [1] 267003 0
01/03/2011
Ethics approval number [1] 267003 0
1/10/0421

Summary
Brief summary
this study seeks to determine if minimially invasive monitors can detect blood loss in awake patients. Our hypothesis is that the monitors will be able to detect a known blood loss of 10% of estimated blood volume.
We will test this by bleeding volunteers a known amount of blood and then looking to see if the monitors detect this blood loss.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32576 0
Address 32576 0
Country 32576 0
Phone 32576 0
Fax 32576 0
Email 32576 0
Contact person for public queries
Name 15823 0
Edmond O'Loughlin
Address 15823 0
Department of Anaesthesia
Fremantle Hospital
Fremantle, WA 6160
Country 15823 0
Australia
Phone 15823 0
+ 61 8 9431 3333
Fax 15823 0
Email 15823 0
edmond.o'[email protected]
Contact person for scientific queries
Name 6751 0
Edmond O'Loughlin
Address 6751 0
Department of Anaesthesia
Fremantle Hospital
Fremantle, WA 6160
Country 6751 0
Australia
Phone 6751 0
+ 61 8 9431 3333
Fax 6751 0
Email 6751 0
edmond.o'[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
SourceTitleYear of PublicationDOI
EmbaseControlled moderate hypovolaemia in healthy volunteers is not associated with the development of oxidative stress assessed by plasma F2-isoprostanes and isofurans.2016https://dx.doi.org/10.1016/j.prostaglandins.2016.07.001
N.B. These documents automatically identified may not have been verified by the study sponsor.