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Efficacy of AirGLovE in Difficult Venous Access

Assessment by Ultrasound of the Degree of Venous Dilation, Comparison Between Venodilation by Airglove (TM) Versus Warm-water Immersion (WWI)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05127668
Acronym
EAGLE
Enrollment
34
Registered
2021-11-19
Start date
2019-03-29
Completion date
2019-04-16
Last updated
2021-11-19

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

Conditions

Cancer

Keywords

Cannulation,, Chemotherapy, Difficult venous access, Difficult venepuncture, Cancer

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.

Interventions

DEVICEAirglove (TM)

A sterile polythene-balloon was inflated around the forearm using the AirGloveTM to 38.5oC at setting number-3 for 3 minutes, then removed and the degree of venodilation assessed by ultrasound.

DEVICEWarm-water Immersion

The upper limbs (to the level of mid-humerus) of participants were immersed in a container filled with a mix of cold-and warm tap-water to 38.5oC for 3 minutes in the WWI method. Arms were towel-dried, and the degree of venodilation was assessed by ultrasound

Sponsors

Glasgow Caledonian University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

The investigator and reviewer were masked to the results

Intervention model description

Prospective cross-sectional comparative study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Name of Measurement: Change in measurement of vein diameter by ultrasoundChange from baseline measurements taken within 2 minutes of the interventionMEASUREMENT TOOL: GE Logic S8 multi-frequency linear-array transducer (L6-15MHz), two-dimension B-mode ultrasound

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026