Efficacy of AirGLovE in Difficult Venous Access (EAGLE)

Glasgow Caledonian University

Status: Completed

Conditions: Cancer

Treatments: Device: Airglove (TM); Device: Warm-water Immersion

Study type: Interventional

Funder types: Other

Identifiers

NCT05127668

HLS/PSWAHS/18/168

Details and patient eligibility

About

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

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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34 participants in 2 patient groups

Airglove arm

Experimental group

Description:

Participants on the airglove arm were subjected to warming of their forearms using the Airglove device at 38.5oC.

Treatment:

Device: Airglove (TM)

Warm-water Immersion arm

Experimental group

Description:

Participants on the WWI arm were subjected to warming by immersing their forearms into a bucket of warm water at 38.5oC.

Treatment:

Device: Warm-water Immersion