Efficacy of AirGLovE in Difficult Venous Access

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Device: Warm-water Immersion; Device: Airglove (TM)

• Registration Number: NCT05127668
• Lead Sponsor: Glasgow Caledonian University

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.

Study Timeline

• Study Start: 2019-03-29
• Primary Completion: 2019-04-16
• Study Completion: 2019-04-16
• Study First Submitted: 2021-09-14
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-08
• Last Update Submitted: 2021-11-08
• Study First Posted: 2021-11-19
• Last Update Posted: 2021-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Warm-water Immersion arm	Warm-water Immersion	Participants on the WWI arm were subjected to warming by immersing their forearms into a bucket of warm water at 38.5oC.
Airglove arm	Airglove (TM)	Participants on the airglove arm were subjected to warming of their forearms using the Airglove device at 38.5oC.

Primary Outcome Measures

Name	Time	Method
Name of Measurement: Change in measurement of vein diameter by ultrasound	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

Trial Locations

Locations (1)

Glasgow Calenonian University; 🇬🇧 Glasgow, South Lanarkshire, United Kingdom