Efficacy of AirGLovE in Difficult Venous Access

NCT ID: NCT05127668

Last Updated: 2021-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-29
• Study Completion Date: 2019-04-16

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.

Conditions

Cancer

Keywords

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Airglove arm

Participants on the airglove arm were subjected to warming of their forearms using the Airglove device at 38.5oC.

Group Type: EXPERIMENTAL

Airglove (TM)

Intervention Type: 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 arm

Participants on the WWI arm were subjected to warming by immersing their forearms into a bucket of warm water at 38.5oC.

Group Type: EXPERIMENTAL

Warm-water Immersion

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Glasgow Caledonian University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Glasgow Calenonian University

Glasgow, South Lanarkshire, United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

HLS/PSWAHS/18/168

Identifier Type: -

Identifier Source: org_study_id