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Trial registered on ANZCTR


Registration number
ACTRN12622000404729
Ethics application status
Approved
Date submitted
15/02/2022
Date registered
9/03/2022
Date last updated
20/02/2023
Date data sharing statement initially provided
9/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
SPOTLESS 2- Prospective trial investigating the safety of peripheral vasopressors in pre-hospital and retrieval medicine
Scientific title
Prospective trial investigating the safety of peripheral vasopressors in pre-hospital and retrieval medicine
Secondary ID [1] 306431 0
nil
Universal Trial Number (UTN)
Trial acronym
SPOTLESS 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sepsis 325265 0
shock 325266 0
haemorrhage 325267 0
trauma 325268 0
Condition category
Condition code
Emergency medicine 322667 322667 0 0
Resuscitation
Emergency medicine 322668 322668 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
New Standard Operating Procedure on how to run peripheral vasopressors safely
-Using peripheral Cannulae in the arms or below the knees
-Must be <5cm long
-Infusing Adrenaline or Noradrenaline via pump or syringe driver (B-Braun)
-Treatment as felt indicated by treating retrieval clinician in liaison with retrieval co-ordinator
-Duration of treatment recorded as arrival of team with patient to handover at receiving facility, so includes ground, air and any road legs to transfer.
-Complications followed out to 24 hours post handover at receiving
-Infusions will be run per protocol involving dedicated lines, regular line obs and guidance on site and type of canula and patency checks prior to use.

Guideline based on internal audit data and literature, was an update on last 2016 guideline. It will be attached to this document and available.

Due to the configuration on pumps, initial recording will be in mcg/min, audit range for this was 1-50mcg/min with medians for adrenaline and noradrenaline peripherally of around 12mcg/min. As this study includes children mcg/kg/min will also be provided in write up based on known patients weights also collected.

Compliance is asked with tick box questions in the data collection page. Adverse events are investigated via internal and external governance and adherence to the guideline would be part of any investigation.

Care based on updated SOP and education from retrospective study was planned to be reaudited with a new data capture page dedicated to peripheral vasopressors as specific questions related to it.
This new data capture became live on 1st April 2022. Data from this prospectively collected cohort will be included in the analysis from 1st April onwards. Full ethics was received on 18/7/22 and at that stage 116 patients had already been captured
Intervention code [1] 322865 0
Prevention
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330465 0
Complications of peripheral vasopressors graded by severity and type
Tissue
-minor: skin reactions requiring no treatment
-moderate: any reaction requiring topical or infiltrative treatment
-severe: any reaction with tissue loss requiring debridement or surgical intervention
Operational
Minor: line kinks/disconnects with pressure alarms but no hypotension
Moderate: line kinks/disconnects with hypotension or delayed recognition
Severe: Line dislodged requiring transfer to another line or any prolonged >5 minute hypotension due to peripheral vasopressor

outcome is assessed by data linkage to medical records using a mix of medical and nursing notes, skin assessments as part of this and any operation notes and clinical photography will give a good assessment of any complications.
Timepoint [1] 330465 0
within 24 hours of transport
Secondary outcome [1] 406323 0
- What is the complication rate in the use of peripheral vasopressors in this population?
o Including: What is the incidence of complications up to 24 hours post retrieval to destination hospital
o What are the types of complication: local, systemic etc, also stratified by harm: no treatment required but evidence of extravasation, minor morbidity (ie skin necrosis), major morbidity (tissue damage requiring debridement, systemic hypotension with associated complications)
o What treatment is required to manage complications, both immediately and within the first 24 hours in hospital post retrieval
- What sites and types of access are used
- Which monitoring is used: invasive or non-invasive blood pressure, whilst on peripheral vasopressors
- What are the indications for peripheral vasopressor use
- What is the dosage and peak doses of peripheral vasopressors

data is collected via data linkage to medical records
Timepoint [1] 406323 0
during transit

Eligibility
Key inclusion criteria
any patient being transferred by Lifeflight retrieval medicne receiving peripheral vasopressors, including inter facility and pre hospital work.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Complication of peripheral vasopressor prior to transfer
- Patient not transported by LRM ie clinical improvement or decline precluding transport

Study design
Purpose of the study
Prevention
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Previous literature from ED and ICU has shown complications of 2-7% and internal audit has shown rates of 3.7-5%.
A sample size of 400 was chosen in order to be able to achieve a 80% power for an alpha of 0.05 comparing a 7% event at upper limit with our reported of 3.7%.

Simple means for study population demographics
percentages for indications, complications and sites
p values for complications

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/03/2022
Actual
1/04/2022
Date of last participant enrolment
Anticipated
31/03/2024
Actual
Date of last data collection
Anticipated
31/03/2024
Actual
Sample size
Target
400
Accrual to date
300
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 310778 0
Commercial sector/Industry
Name [1] 310778 0
Lifeflight Retrieval Medicine
Country [1] 310778 0
Australia
Primary sponsor type
Individual
Name
Robert Ley Greaves
Address
Lifeflight Retrieval Medicine
43 Pandanus Avenue Brisbane Airport
4008
Brisbane
Queensland
Country
Australia
Secondary sponsor category [1] 312017 0
Individual
Name [1] 312017 0
Andrew Holgate
Address [1] 312017 0
Lifeflight Retrieval Medicine
43 Pandanus Avenue Brisbane Airport
4008
Brisbane
Queensland
Country [1] 312017 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310353 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 310353 0
Butterfeild Street
Herston 4029
Brisbane
Queensland
Ethics committee country [1] 310353 0
Australia
Date submitted for ethics approval [1] 310353 0
22/02/2022
Approval date [1] 310353 0
18/07/2022
Ethics approval number [1] 310353 0
HREC/2022/QRBW/84346

Summary
Brief summary

Peripheral vasopressors are safe and effective to use in pre-hospital and retrieval medicine with a similar risk profile to administration in Emergency departments

Prospective data collection on the use of peripheral vasopressors in prehospital and retrieval medicine. Studying patients transported by Lifeflight retrieval medicine who operate across Queensland in Australia.
Primary outcome is safety with secondary endpoints including monitoring and indication as well as site and type of access.
Trial website
Trial related presentations / publications
Public notes
Data collection had started already for internal audit purposes after a change in standard operating procedure before ethics for this study was granted, so listed recruitment is as of 1st April 2022 when data collection for the audit began.

Contacts
Principal investigator
Name 117350 0
Dr Robert Ley Greaves
Address 117350 0
Lifeflight Retrieval Medicine
43 Pandanus Avenue
Brisbane Airport 4008
Brisbane
Queensland
Country 117350 0
Australia
Phone 117350 0
+61 416621858
Fax 117350 0
Email 117350 0
[email protected]
Contact person for public queries
Name 117351 0
Robert Ley Greaves
Address 117351 0
Lifeflight Retrieval Medicine
43 Pandanus Avenue
Brisbane Airport 4008
Brisbane
Queensland
Country 117351 0
Australia
Phone 117351 0
+61 416621858
Fax 117351 0
Email 117351 0
[email protected]
Contact person for scientific queries
Name 117352 0
Robert Ley Greaves
Address 117352 0
Lifeflight Retrieval Medicine
43 Pandanus Avenue
Brisbane Airport 4008
Brisbane
Queensland
Country 117352 0
Australia
Phone 117352 0
+61 416621858
Fax 117352 0
Email 117352 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Conditional on ethics
When will data be available (start and end dates)?
after completion estimated March 2024
data available for 5 years post completion
Available to whom?
Authors for meta-analysis with Ethical approval
Available for what types of analyses?
meta-analysis
How or where can data be obtained?
formal request to authors via email to PI ([email protected]) and RBWH HREC ethics committee


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.