Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000490370
Ethics application status
Not yet submitted
Date submitted
25/08/2008
Date registered
30/09/2008
Date last updated
30/09/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of the anaesthetic conserving device in the Intensive Care
Scientific title
Use of the anaesthetic conserving device in post operative patients requiring ventilation to assess if time to extubation and quantity of intravenous sedation can be reduced
Secondary ID [1] 702 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sedation in post-operative patients in ICU (Intensive Care Unit) 3607 0
Condition category
Condition code
Surgery 3763 3763 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Anaesthetic conserving device 'Anaconda' for sedation in post- operative cardiac patients requiring temporary ventilation. It is placed between the endotracheal tube and the ventilator tubing. It will be used until the time of extubation, or until 24 hours after commencement.
Intervention code [1] 3319 0
Treatment: Devices
Comparator / control treatment
Standard sedation with intravenous benzodiazepines and opioids. That is Midazolam at 1-10mg/hr, and morphine at 1-10mg/hr
Control group
Active

Outcomes
Primary outcome [1] 4661 0
Time to extubation
Timepoint [1] 4661 0
When extubation occurs or 24 hours post commencement of the AnaConda
Secondary outcome [1] 7878 0
Reduction in the amount of intravenous sedation required. This will be compared with non- trial post-operative cardiac patients who will solely receive intravenous agents.
Timepoint [1] 7878 0
24 Hours
Secondary outcome [2] 8189 0
Troponin levels in both groups will be measured and compared. Troponin is a cardiac enzyme which is released by damaged cardiac muscle into the bloodstream. It is measured by taking a blood test. In this study, troponin levels will be measured immediately post-operatively, and after 24 hours.
Timepoint [2] 8189 0
Post-operatively and at 24 hours.

Eligibility
Key inclusion criteria
Post operative Coronary Artery Grafting Surgery (CAGS) patients; Patients post prolonged surgery requiring short term ventilaion in ICU
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with history/family history of malignant hyperthermia. Patients with liver failure

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2008
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)

Funding & Sponsors
Funding source category [1] 3780 0
Self funded/Unfunded
Name [1] 3780 0
A/Prof Warwick Butt
Country [1] 3780 0
Australia
Primary sponsor type
Individual
Name
A/Prof Warwick Butt
Address
ICU, Alfred Hospial, Commercial Road, Prahran, VIC 3181
Country
Australia
Secondary sponsor category [1] 3391 0
None
Name [1] 3391 0
Address [1] 3391 0
Country [1] 3391 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5844 0
Ethics committee address [1] 5844 0
Ethics committee country [1] 5844 0
Date submitted for ethics approval [1] 5844 0
25/08/2008
Approval date [1] 5844 0
Ethics approval number [1] 5844 0

Summary
Brief summary
Patients who are post cardiac surgery, and frequently patients after other prolonged surgery require mechanical ventilation in the ICU until they are stable for extubation. The majority of these patients require some sedation, mainly for endotracheal tube tolerance, cough suppression and to allow routine procedures be performed.
Currently , intravenous sedatives are used in our ICU. The use of inhalational agents such as Sevoflurane and Isoflurane in the intensive care setting, has been widely described in the literature. The advantage of these agents are that they are easily titrated to effect, the level of sedation can be easily monitored, and as they are exceted by the lungs, and not by the liver and kidneys, may be more advantageous in patients with hepatic or renal impairment. Furthermore more, they have been shown to have a cardioprotective effect on those post cardiac surgery in particular and reduce the morbidity and mortality in this group.
In our study, we will enrol 10 patients post CABG surgery to receive Isoflurane via the Anaesthetic Conserving Device (AnaConDa) until the time of extubation. We believe that the time to extubation following cessation of sedation will be shorter compared to those receiving intravenous sedation. We will measure troponin levels, which is a marker of cardiac injury, and compare the levels in those receiving inhalational sedation compared to intravenous sedation.

Patients’ cardiac and respiratory status will be carefully monitored in the ICU setting, and their sedation scores measured. We believe we can reduce the amount of intravenous sedation used in this group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28875 0
Address 28875 0
Country 28875 0
Phone 28875 0
Fax 28875 0
Email 28875 0
Contact person for public queries
Name 12032 0
Eilis Condon
Address 12032 0
ICU, Alfred Hospial, Commercial Road, Prahran, VIC 3181
Country 12032 0
Australia
Phone 12032 0
0390762000
Fax 12032 0
Email 12032 0
[email protected]
Contact person for scientific queries
Name 2960 0
Eilis Condon
Address 2960 0
ICU, Alfred Hospial, Commercial Road, Prahran, VIC 3181
Country 2960 0
Australia
Phone 2960 0
0390762000
Fax 2960 0
Email 2960 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.