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Trial registered on ANZCTR


Registration number
ACTRN12611000237987
Ethics application status
Approved
Date submitted
28/02/2011
Date registered
4/03/2011
Date last updated
25/06/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of Traditional Landmark versus Ultrasound Guided Placement of Percutaneous Tracheostomies in Adult Intensive Care Patients -­ A Randomised Controlled Trial
Scientific title
Comparison, in adult intensive care patients, of ultrasound guided versus traditional landmark guided placement of percutaneous dilatational tracheostomies to determine effect on tracheostomy position.
Secondary ID [1] 259623 0
None
Universal Trial Number (UTN)
Trial acronym
TARGET Study ­ (Traditional landmArk versus ultRasound Guided Evaluation Trial)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Positioning of percutaneous tracheostomies in relation to the tracheal midline and cranio-caudal distance from the cricoid cartilage 261182 0
Condition category
Condition code
Respiratory 259336 259336 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Real time ultrasound guidance will be used to determine tracheal midline and cranio-caudal distance (i.e number of tracheal rings) from the cricoid catilage to determine the the site of the tracheal puncture which is the initial step in a percutaneous dilatational tracheostomy. A bronchoscopic image will be taken after the puncture which will be used to evaluate the puncture position during data analysis. After the puncture, insertion of the tracheostomy will proceed as per the routine used for insertion of a percutanous dilatational tracheostomy. The entire procedure is expected to last between 15-30 minutes.
Intervention code [1] 258056 0
Treatment: Devices
Comparator / control treatment
Tracheal puncture will be carried out without the use of ultrasound, as per the traditional landmark technique (i.e using palpation to identify the landmarks and correct position for insertion of the tracheostomy tube). Puncture will be followed by taking of a bronchoscopic image and routine completion of the percutaneous dilatational tracheostomy.The entire procedure is expected to last between 15-30 minutes.
Control group
Active

Outcomes
Primary outcome [1] 262138 0
Deviation from tracheal midline in degrees as measured on bronchoscopic image scaled to standardised size and fitted to a standard protractor.
Timepoint [1] 262138 0
Bronchoscopic image used for evaluation is taken immediately after the tracheal puncture in both groups.
Primary outcome [2] 262139 0
Cranio-caudal distance from cricoid cartilage (i.e number of tracheal cartilage rings between the puncture and the cricoid cartilage) - Outcomes: <1, 1-3, >3
Timepoint [2] 262139 0
Bronchoscopic image used for evaluation is taken immediately after the tracheal puncture in both groups.
Secondary outcome [1] 273220 0
Time to wean from ventilator
Timepoint [1] 273220 0
Time point recorded once patient has been off ventilator for >24hrs
Secondary outcome [2] 273221 0
Infection - tracheostomy site
Timepoint [2] 273221 0
90 days or until decannulated (whichever occurs first)
Secondary outcome [3] 273222 0
Bleeding related to tracheostomy
Timepoint [3] 273222 0
90 days or until decannulated (whichever occurs first)

Eligibility
Key inclusion criteria
All adult intensive care patients where a decision has been made to insert a percutaneous dilatational tracheostomy
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under 18 years old
Pregnant women

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All adult intensive care patients where a decision has been made to insert a tracheostomy are potential participants in the study. The decision to insert a tracheostomy lies with the Intensive Care Specialists. All intensive Care Specialists will be aware of the study and the requirement to screen potential participants. It will be part of the study protocol for the Specialist to inform a member of the research team once a decision to insert a tracheostomy has been made. Quite often a potential need for a tracheostomy is realised well before the decision is made to insert one (depending on patient progress, etc) so research staff will also regularly contact Staff Specialists to be made aware and keep track of patients that might potentially require the intervention in order to reinforce the need to screen these patients for the study once the decision has been made.

Informed consent to be enrolled in the study will be sought from the Person Responsible at the time of consent for the tracheostomy procedure in general.

Patients where consent has been obtained will be randomly assigned to either of the study groups by drawing the top envelope from a stack of 50 (25 randomly allocated for each group - randomisation as per CONSORT guidelines). The envelopes will be identical and will not allow identification of the group allocation until they are opened.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2672 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 2673 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 3660 0
2050

Funding & Sponsors
Funding source category [1] 258520 0
Charities/Societies/Foundations
Name [1] 258520 0
Australasian Society for Ultrasound in Medicine
Address [1] 258520 0
Level 2, 511 Pacific Hwy
Crows Nest, NSW 2065
Country [1] 258520 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Missenden Road
Camperdown, NSW 2050
Country
Australia
Secondary sponsor category [1] 257657 0
None
Name [1] 257657 0
Address [1] 257657 0
Country [1] 257657 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260561 0
Sydney South West Area Health Service Human Research Ethics Committee (RPAH Zone) EC00113
Ethics committee address [1] 260561 0
Research Development Office
Royal Prince Alfred Hospital
Missenden Road
Camperdown, NSW 2050
Ethics committee country [1] 260561 0
Australia
Date submitted for ethics approval [1] 260561 0
17/01/2011
Approval date [1] 260561 0
09/02/2011
Ethics approval number [1] 260561 0
Reference number: X11-0014 & HREC/11/RPAH/17

Summary
Brief summary
The TARGET Study is a prospective, randomised controlled trial, evaluating two standard techniques of tracheal puncture during insertion of percutaneous tracheostomies: the traditional landmark method versus the ultrasound guided method.
Percutaneous Dilatational Tracheostomy (PTD) is a frequently performed invasive procedure in the Intensive Care setting, where complications both immediate and short term can contribute to significant morbidity and mortality. It is increasingly recognised that lateral (off midline) and cranio­caudal (too high up or too low down) malposition of PDTs may result in greater incidence of both short and long term complications.
The use of ultrasonography in placing tracheostomies is well described in the literature. We aim to evaluate the use of real­time ultrasound guidance for the tracheal puncture, which is the most important determining element in positioning the tracheostomy, to determine which method results in better midline and cranio­caudal placement. Better midline and cranio-caudal placement in turn may decrease complications and improve clinically significant surrogate markers of outcome.
Trial website
Trial related presentations / publications
1, Rudas M, Herkes R, Hislop R, Rajbhandari D, Seppelt I, Weisbrodt L (October 2012) Real-time Ultrasound Guided Tracheal Puncture During Percutaneous Dilatational Tracheostomy Significantly Improves First Pass Success Rate And Accuracy, Oral session presentation at the Australasian Society for Ultrasound in Medicine ASUM ASM in Sydney

2, Rudas M, Herkes R, Hislop R, Rajbhandari D, Seppelt I, Weisbrodt L, (October 2012) Real-time Ultrasound Guided Tracheal Puncture During Percutaneous Dilatational Tracheostomy Significantly Improves First Pass Success Rate And Accuracy, Oral session presentation at the Australian and New Zealand Intensive Care Society ANZICS ASM in Adelaide
Public notes

Contacts
Principal investigator
Name 32227 0
Dr Mate Rudas
Address 32227 0
Intensive Care Services
Royal Prince Alfred Hospital
Missenden Road, Camperdown
NSW 2050 Australia
Country 32227 0
Australia
Phone 32227 0
+61295157668
Fax 32227 0
Email 32227 0
rudasdoc@yahoo.com
Contact person for public queries
Name 15474 0
Dr Mate Rudas
Address 15474 0
Intensive Care Services
Royal Prince Alfred Hospital
Missenden Road, Camperdown
NSW 2050 Australia
Country 15474 0
Australia
Phone 15474 0
+61 2 9515 5513
Fax 15474 0
+61 2 9515 4373
Email 15474 0
rudasdoc@yahoo.com
Contact person for scientific queries
Name 6402 0
Dr Mate Rudas
Address 6402 0
Intensive Care Services
Royal Prince Alfred Hospital
Missenden Road, Camperdown
NSW 2050 Australia
Country 6402 0
Australia
Phone 6402 0
+61 2 9515 5513
Fax 6402 0
+61 2 9515 4373
Email 6402 0
rudasdoc@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary