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Clinical trial of a novel tourniquet (Vacuderm tourniquet) which aims to aid further filling of veins through a pumping mechanism

Randomised control trial of a novel tourniquet (Vacuderm tourniquet) which aims to aid further filling of veins through a pumping mechanism

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN52096917
Enrollment
160
Registered
2017-03-27
Start date
2017-01-09
Completion date
Unknown
Last updated
2021-05-17

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

Conditions

Diffficult venous access - cannulation procedure Not Applicable

Interventions

Participants are randomised to undergo cannulation using either the Vacuderm tourniquet or the control, which is the conventional standard tourniquet. Participants will be recruited on to the trial if
the second attempt will be performed after the participant has been randomised.

Sponsors

Olberon Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Emergency department patients aged 18 and over 2. Able to provide informed consent 3. Requiring venous cannulation 4. Has had a first attempt failed cannulation within the emergency department during this attendance 5. The patient has an appropriate site for cannulation in the upper limbs in the opinion of the investigator

Exclusion criteria

Exclusion criteria: 1. In the opinion of the investigator the patient has a contra-indication to use of tourniquet or blood pressure cuff (for example a low platelet count causing bruising) 2. Critically ill patients who need emergent IV access 3. Small cannula being used on patient – ie 22 gauge (blue) and smaller

Design outcomes

Primary

MeasureTime frame
Success rate of venous cannulation, measured by recording the tourniquet (Vacuderm or control tourniquet) used and whether the cannulation attempt was successful

Secondary

MeasureTime frame
1. Safety: an inspection of the tourniquet site will be carried out after 30 minutes and any adverse events will be recorded in the case report form 2. User acceptability, recorded on the case report form, whether cannulation was successful or not 3. Patient/participant satisfaction, measured using a visual analogue scale (VAS) 4. Cannula size, recorded on the case report form for the first failed attempt at cannulation and the cannula size will again be recorded after randomisation for the second attempt 5. Provisional diagnosis, recorded by the trained delegate on the case report form 6. Potassium levels - haemolysis, recorded by the trained delegate on the case report form All measured at a single timepoint

Countries

United Kingdom

Contacts

Public ContactKara Baron
kara@olberon.com+44 (0)115 802 2025

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026