Clinical trial NCT05127668: Efficacy of AirGLovE in Difficult Venous Access
Official title: Assessment by Ultrasound of the Degree of Venous Dilation, Comparison Between Venodilation by Airglove (TM) Versus Warm-water Immersion (WWI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Cannulation,
Chemotherapy
Difficult venous access
Difficult venepuncture
Cancer
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective cross-sectional comparative study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To determine whether Airglove™ warming device dilates upper limb veins to the same degree as the warm water immersion (WWI) method.

Detailed description: Failure to cannulate to gain intra-venous access is a common occurrence in patients undergoing chemotherapy, obese patients, intravenous drug users and those with chronic medical problems leading to peripheral venous collapse. Difficulty in gaining IV-access is a serious medical consequence since important life-saving drugs, fluids, blood transfusions, and other medication are usually given via the intravenous route. Most chemotherapy units in the UK rely on venous dilation by immersing the forearm of patients with "difficult to cannulate veins" (DTCV) into a bucket of warm water. There are however, limitations in this method such as controlling water temperature and ensuring proper sterility.

A new device Airglove™ has been developed which directs warm air over the forearm in a polythene sleeve causing venodilation. Preliminary studies in chemotherapy patients suggest that the Airglove™ causes venodilation to the extent of the warm water immersion technique, however further evidence is required with testing on normal healthy volunteers.

Aims and Objectives:

To determine whether Airglove™ warming device dilates upper limb veins to the same degree as the warm water immersion (WWI) method.

Eligibility criteria: Inclusion Criteria:

* Participants \> 18 years old
* Able to give written informed consent
* Able to understand and complete questionnaire forms independently

Exclusion Criteria:

* Participants \< 18 years old
* Participants with cancer and/or undergoing chemotherapy
* Participants with difficult to cannulate veins (DTCV)
* Participants with lymphoedema in either hand
* Participants with pre-existing Raynaud's disease
* Participants with Diabetes (Type 1 \& 2)
* Participants with generalised anxiety disorder
* Participants with diagnosis of hypertension
* Participants with any cardiovascular disease, previous stroke, episodes of DVT, recent treatment for venous thromboembolism (VTE), recently administered heparin, participants on warfarin or any anticoagulant treatment (including NOACs).
* Participants not able to give written informed consent
* Participants not able to comprehend or complete questionnaire forms independently

Primary outcomes:
measure: Name of Measurement: Change in measurement of vein diameter by ultrasound
timeFrame: Change from baseline measurements taken within 2 minutes of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Glasgow Calenonian University
state: South Lanarkshire
Study officials:
References: