Efficacy of AirGLovE in Difficult Venous Access (EAGLE)

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

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

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Device: Airglove (TM); Device: Warm-water Immersion

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • South Lanarkshire
    • Glasgow, South Lanarkshire, United Kingdom, G4 0BA
      • Glasgow Calenonian University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Airglove arm; Participants on the airglove arm were subjected to warming of their forearms using the Airglove device at 38.5oC.	Device: Airglove (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.
Experimental: Warm-water Immersion arm; Participants on the WWI arm were subjected to warming by immersing their forearms into a bucket of warm water at 38.5oC.	Device: Warm-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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Name of Measurement: Change in measurement of vein diameter by ultrasound	MEASUREMENT TOOL: GE Logic S8 multi-frequency linear-array transducer (L6-15MHz), two-dimension B-mode ultrasound	Change from baseline measurements taken within 2 minutes of the intervention

Collaborators and Investigators

• Sponsor: Glasgow Caledonian University

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2019
• Primary Completion (Actual): April 16, 2019
• Study Completion (Actual): April 16, 2019

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: November 8, 2021
• First Posted (Actual): November 19, 2021

Study Record Updates

• Last Update Posted (Actual): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 8, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Cancer; Chemotherapy; Cannulation,; Difficult venous access; Difficult venepuncture
• Other Study ID Numbers: HLS/PSWAHS/18/168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No