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Trial registered on ANZCTR


Registration number
ACTRN12615000870550
Ethics application status
Approved
Date submitted
20/06/2015
Date registered
21/08/2015
Date last updated
17/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Thoracic Trauma Endoscope Guided Intercostal Catheter Insertion
Scientific title
Phase I study to evaluate the placement accuracy of endoscope guided intercostal catheter insertion in thoracic trauma patients
Secondary ID [1] 286946 0
Nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pleural decompression and drainage for thoracic trauma 295384 0
Condition category
Condition code
Surgery 295646 295646 0 0
Surgical techniques
Injuries and Accidents 295783 295783 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Under local anesthesia and/or procedural sedation a sterilized Karl Storz Endoscope will be inserted into a 28F intercostal catheter (ICC) and under full aseptic technique inserted through a standard ICC chest incision into the pleural space by the operating emergency or trauma physician.
This will permit direct visualization and navigation of tissue planes and intra-pleural structures guiding ICC placement.
Once placed the ICC will be secured to the chest wall and chest incision closed by suturing, the endoscope will be removed and the ICC connected to an underwater chest drain.
The duration of procedure is estimated at less than 20 minutes for completion.
Intervention code [1] 292140 0
Treatment: Surgery
Intervention code [2] 292258 0
Treatment: Devices
Comparator / control treatment
A concurrent control group of 20 adult thoracic trauma patients requiring pleural decompression and drainage using the current standard, 'blind' insertion technique as well as an historical control of 100 patients to account for any Hawthorne effect. Historical data will be derived from the Alfred Trauma Registry data recorded from August to December 2014.
The current standard of 'blind' ICC insertion involves a surgical incision with blunt dissection of the chest wall and subsequent puncture of the pleura. Access to the pleura is confirmed via digital exploration using a sterile gloved finger. ICC insertion is then carried out using forceps and digital guidance before being secured to the chest wall by surgical sutures. The procedure takes up to 20 minutes from set-up to securing the ICC.
Control group
Active

Outcomes
Primary outcome [1] 295361 0
Correct placement of ICC as visualised on Chest X-ray and CT
Timepoint [1] 295361 0
First image post ICC insertion
Secondary outcome [1] 315422 0
Procedural time
Timepoint [1] 315422 0
Time from procedure commencement to completion
Secondary outcome [2] 315423 0
Hospital length of stay
Timepoint [2] 315423 0
Time from procedure commencement to discharge.
Secondary outcome [3] 315683 0
Procedural protocol violations:
Self-reported by researcher performing procedure.
Written report provided to reviewing HREC.
Timepoint [3] 315683 0
Time from procedural commencement to completion
Secondary outcome [4] 315684 0
Time to subsequent ICC repositioning or removal
Timepoint [4] 315684 0
Time from completion of initial insertion procedure to commencement of repositioning or removal procedure
Secondary outcome [5] 315685 0
Infection incidence.
Laboratory confirmed infection.
Timepoint [5] 315685 0
Time from procedure commencement to discharge.
Secondary outcome [6] 315686 0
Mortality
Timepoint [6] 315686 0
Death occurring at any time from procedural commencement to discharge

Eligibility
Key inclusion criteria
Thoracic Trauma patients; 18 -75 years of age requiring pleural decompression, intercostal catheter insertion and drainage
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Haemodynamically unstable patients

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)
Patients requiring tube thoracostomy will be identified by consultation with the emergency physicians and trauma service on admission, on days where the principle investigators are available. Those patients fitting the inclusion criteria will be prospectively allocated to the intervention group. When principle investigators are not available, patient will be allocated to the control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a Phase 1, non randomised trial.
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
Statistical methods / analysis
Information to be collected include age, sex, weight, injury diagnoses, vital signs before and during procedure, procedural time, ICC position on subsequent chest X-ray/CT scan, procedural protocol violations, subsequent ICC re-positioning or removal, infection incidence, mortality and hospital length of stay.
The data will be collected in and analysed using Stata 13.1.
Fisher’s exact test will be used to calculate the significance of differences. Kaplan-Meier analysis will be undertaken to generate tables and plots of length of time from insertion to re-insertion or removal of ICC.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Trial stopped early secondary to end of lease of intervention equipment (videoscope) from Karl-Storz. Equipment. Videoscope had been leased to other client from June 2016.
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)
VIC
Recruitment hospital [1] 3950 0
The Alfred - Prahran
Recruitment postcode(s) [1] 9861 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 291506 0
Hospital
Name [1] 291506 0
The Alfred Trauma Service
Address [1] 291506 0
Commercial Road
Melbourne
VIC 3004
Country [1] 291506 0
Australia
Primary sponsor type
Hospital
Name
The Alfred Trauma Service
Address
Commercial Road
Melbourne
VIC 3004
Country
Australia
Secondary sponsor category [1] 290185 0
None
Name [1] 290185 0
Nil
Address [1] 290185 0
Nil
Country [1] 290185 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293046 0
The Alfred Hospital Ethics Committee
Ethics committee address [1] 293046 0
Commercial Road
Melbourne
VIC 3004
Ethics committee country [1] 293046 0
Australia
Date submitted for ethics approval [1] 293046 0
23/07/2015
Approval date [1] 293046 0
21/10/2015
Ethics approval number [1] 293046 0
21/10/2015

Summary
Brief summary
We wish to demonstrate that in adult patients with thoracic trauma requiring tube thoracostomy, the insertion of a sterile, flexible endoscope into the intercostal catheter at the time of insertion will allow direct visualization and guided placement of the catheter into the ideal position.
The aim of this small, prospective, preliminary Phase 1 equivalent study is to refine the set-up, procedure, logistics and Trauma Team mechanics related to video-assisted ICC placement. It will be the basis for a larger, randomized trial to determine whether this new technique will remove the commonest complication of ICC insertion for trauma and lead to improved outcomes and a reduced length of hospital stay.
Trial website
nil
Trial related presentations / publications
nil
Public notes
Ethics approval granted on 21/10/2015

Contacts
Principal investigator
Name 58222 0
Prof Mark Fitzgerald
Address 58222 0
National Trauma Research Institute
Commercial Road
Melbourne
VIC 3004
Country 58222 0
Australia
Phone 58222 0
+61390762000
Fax 58222 0
Email 58222 0
Mark.Fitzgerald@monash.edu
Contact person for public queries
Name 58223 0
Prof Mark Fitzgerald
Address 58223 0
National Trauma Research Institute
Commercial Road
Melbourne
VIC 3004
Country 58223 0
Australia
Phone 58223 0
+61390762000
Fax 58223 0
Email 58223 0
Mark.Fitzgerald@monash.edu
Contact person for scientific queries
Name 58224 0
Prof Mark Fitzgerald
Address 58224 0
National Trauma Research Institute
Commercial Road
Melbourne
VIC 3004
Country 58224 0
Australia
Phone 58224 0
+61390762000
Fax 58224 0
Email 58224 0
Mark.Fitzgerald@monash.edu

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