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Completed

NCT Number: NCT05127668

Efficacy of AirGLovE in Difficult Venous Access

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

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Glasgow Calenonian University

Glasgow, South Lanarkshire, G4 0BA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Airglove (TM)

Device

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.

Warm-water Immersion

Device

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

Primary outcomes

  1. Name of Measurement: Change in measurement of vein diameter by ultrasound

    Time frame: Change from baseline measurements taken within 2 minutes of the intervention

    MEASUREMENT TOOL: GE Logic S8 multi-frequency linear-array transducer (L6-15MHz), two-dimension B-mode ultrasound

Sponsors and collaborators

Lead sponsor

Glasgow Caledonian University

Other

Registry information

Official study title

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

Acronym: EAGLE

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 19, 2021
Registry last updated
Nov 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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