Efficacy of AirGLovE in Difficult Venous Access

Cancer Clinical Trial

— EAGLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05127668
• Other study ID #: HLS/PSWAHS/18/168
• Status: Completed
• Phase: N/A
• Start date: March 29, 2019
• Est. completion date: April 16, 2019

Study information

• Verified date: November 2021
• Source: Glasgow Caledonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 16, 2019
• Est. primary completion date: April 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.
• 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

Locations

Country	Name	City	State
United Kingdom	Glasgow Calenonian University	Glasgow	South Lanarkshire

Sponsors (1)

Lead Sponsor	Collaborator
Glasgow Caledonian University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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