Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001301550
Ethics application status
Approved
Date submitted
8/10/2024
Date registered
25/10/2024
Date last updated
25/10/2024
Date data sharing statement initially provided
25/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Analogue versus Digital Intervention in Chest Trauma (ADICT): A prospective randomized control trial on the efficacy of digital thoracostomy drain versus the analogue counterpart following major thoracic trauma
Scientific title
Analogue versus Digital Intervention in Chest Trauma (ADICT): A prospective randomized control trial on the efficacy of digital thoracostomy drain versus the analogue counterpart following major thoracic trauma in participants 16 years or older
Secondary ID [1] 313144 0
none
Universal Trial Number (UTN)
Trial acronym
ADICT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chest trauma 335404 0
pneumothorax 335510 0
haemothorax 335511 0
Condition category
Condition code
Injuries and Accidents 331972 331972 0 0
Other injuries and accidents
Respiratory 332067 332067 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
digital chest drain system for use in traumatic pneumonia/haemthorax. This drain will be connected directly to the intercostal catheter (ICC) in the same way as the current analogue drain is. Members of the trauma team (RNs or doctors) connect this train as part of the procedure when inserting an ICC. The duration of the ICC insertion / drain is dependent upon the lung reinflating, but is usually 2-3 days.
Review of electronic medical records will be used to determine this. All data will be available from the EMR. Although the digital drain offers further data (e.g. air leak) it will not be used as part of the study as comparable data can not be collected for analogue drains.
Intervention code [1] 329716 0
Treatment: Devices
Comparator / control treatment
analogue (underwater seal) drain. This is connected directly to the intercostal catheter and is currently standard practice.
Control group
Active

Outcomes
Primary outcome [1] 339583 0
Total time (hours) of intercostal catheter
Timepoint [1] 339583 0
at the end hospital admission
Secondary outcome [1] 440504 0
Hospital length of stay
Timepoint [1] 440504 0
at the end of hospital admission.
Secondary outcome [2] 440505 0
ICU length of stay
Timepoint [2] 440505 0
at the end of hospital admission.
Secondary outcome [3] 440506 0
number of intercostal drains inserted
Timepoint [3] 440506 0
at the end of hospital admission.
Secondary outcome [4] 440507 0
number of chest radiographs
Timepoint [4] 440507 0
at the end of hospital admission.
Secondary outcome [5] 440508 0
Adverse Events (drain failure, ICC reinsertion, recurrent pneumonia/haemothorax)
Timepoint [5] 440508 0
at the end of hospital admission.

Eligibility
Key inclusion criteria
traumatic chest injury requiring intercostal catheter insertion
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
pre-hospital intercostal catheter insertion
massive haemothorax
open thoracotomy in ED

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)
sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation (via an independent statistician)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The sample size calculation for the primary outcome (the total time in minutes of thoracic catheterization) has conservatively chosen the larger standard deviation value of 2.73 days observed in Pompili19. Based on the mean time of insertion of 3 days, and the standard deviation of 2.73 days, with significance level at 5% and power at 80%, a sample size of 118 participants per treatment arm is required to detect a clinically meaningful effect size of 1 day. Accounting for possible dropout rate of 10% a target total sample size of 262 participants will be required.
The distribution of baseline data will be presented by intervention arm. Continuous baseline data that is normally distributed (e.g. age) will be presented as mean ± standard deviation (SD), and non-normally distributed data (e.g. pre-hospital times) as median and interquartile range (IQR). Categorical data (e.g. sex of patient) will be presented as frequency and proportions.
The primary outcome will be analysed using the two-sample t-test and presented as the mean difference in total minutes of ICC insertion when the Thopaz drain was used compared to the Atrium. The 95% confidence interval and p-value for this difference will be presented.
Although it is expected that most patients will survive until removal of the ICC and to leave hospital, a secondary analysis will be performed on survivors.
The length of stay in hospital and in ICU will be compared between the intervention and control groups. This is expected to be positively skewed and will be presented as median (inter-quartile range) and compared using quantile regression. The number of ICCs, CXRs, and adverse events in each intervention group will be presented as frequency and proportions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
30/04/2026
Actual
Date of last data collection
Anticipated
31/07/2026
Actual
Sample size
Target
262
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27200 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 43282 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 317588 0
Commercial sector/Industry
Name [1] 317588 0
Device Technologies/Medela
Country [1] 317588 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
Country
Australia
Secondary sponsor category [1] 319891 0
None
Name [1] 319891 0
Address [1] 319891 0
Country [1] 319891 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316291 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 316291 0
Ethics committee country [1] 316291 0
Australia
Date submitted for ethics approval [1] 316291 0
Approval date [1] 316291 0
30/05/2023
Ethics approval number [1] 316291 0

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

Contacts
Principal investigator
Name 137418 0
Dr Matthew Walsh
Address 137418 0
Royal Melbourne Hospital,300 Grattan St, Parkville VIC 3052
Country 137418 0
Australia
Phone 137418 0
+61393424875
Fax 137418 0
Email 137418 0
[email protected]
Contact person for public queries
Name 137419 0
Matthew Walsh
Address 137419 0
Royal Melbourne Hospital,300 Grattan St, Parkville VIC 3052
Country 137419 0
Australia
Phone 137419 0
+61393424875
Fax 137419 0
Email 137419 0
[email protected]
Contact person for scientific queries
Name 137420 0
Matthew Walsh
Address 137420 0
Royal Melbourne Hospital,300 Grattan St, Parkville VIC 3052
Country 137420 0
Australia
Phone 137420 0
+61393424875
Fax 137420 0
Email 137420 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.