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SPOTLESS 2- Prospective trial investigating the safety of peripheral vasopressors in pre-hospital and retrieval medicine

Prospective trial investigating the safety of peripheral vasopressors in pre-hospital and retrieval medicine

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000404729
Acronym
SPOTLESS 2
Enrollment
625
Registered
2022-03-09
Start date
2022-04-01
Completion date
2023-08-31
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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. -Complicatio

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

Sponsors

Robert Ley Greaves
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Healthy volunteers
No

Inclusion criteria

any patient being transferred by Lifeflight retrieval medicne receiving peripheral vasopressors, including inter facility and pre hospital work.

Exclusion criteria

- Complication of peripheral vasopressor prior to transfer - Patient not transported by LRM ie clinical improvement or decline precluding transport

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026